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The way a baby is positioned in the uterus just before birth can have a big effect on labor and delivery. This positioning is called fetal presentation.

Babies twist, stretch and tumble quite a bit during pregnancy. Before labor starts, however, they usually come to rest in a way that allows them to be delivered through the birth canal headfirst. This position is called cephalic presentation. But there are other ways a baby may settle just before labor begins.

Following are some of the possible ways a baby may be positioned at the end of pregnancy.

Head down, face down

When a baby is head down, face down, the medical term for it is the cephalic occiput anterior position. This the most common position for a baby to be born in. With the face down and turned slightly to the side, the smallest part of the baby's head leads the way through the birth canal. It is the easiest way for a baby to be born.

Head down, face up

When a baby is head down, face up, the medical term for it is the cephalic occiput posterior position. In this position, it might be harder for a baby's head to go under the pubic bone during delivery. That can make labor take longer.

Most babies who begin labor in this position eventually turn to be face down. If that doesn't happen, and the second stage of labor is taking a long time, a member of the health care team may reach through the vagina to help the baby turn. This is called manual rotation.

In some cases, a baby can be born in the head-down, face-up position. Use of forceps or a vacuum device to help with delivery is more common when a baby is in this position than in the head-down, face-down position. In some cases, a C-section delivery may be needed.

Frank breech

When a baby's feet or buttocks are in place to come out first during birth, it's called a breech presentation. This happens in about 3% to 4% of babies close to the time of birth. The baby shown below is in a frank breech presentation. That's when the knees aren't bent, and the feet are close to the baby's head. This is the most common type of breech presentation.

If you are more than 36 weeks into your pregnancy and your baby is in a frank breech presentation, your health care professional may try to move the baby into a head-down position. This is done using a procedure called external cephalic version. It involves one or two members of the health care team putting pressure on your belly with their hands to get the baby to roll into a head-down position.

If the procedure isn't successful, or if the baby moves back into a breech position, talk with a member of your health care team about the choices you have for delivery. Most babies in a frank breech position are born by planned C-section.

Complete and incomplete breech

A complete breech presentation, as shown below, is when the baby has both knees bent and both legs pulled close to the body. In an incomplete breech, one or both of the legs are not pulled close to the body, and one or both of the feet or knees are below the baby's buttocks. If a baby is in either of these positions, you might feel kicking in the lower part of your belly.

If you are more than 36 weeks into your pregnancy and your baby is in a complete or incomplete breech presentation, your health care professional may try to move the baby into a head-down position. This is done using a procedure called external cephalic version. It involves one or two members of the health care team putting pressure on your belly with their hands to get the baby to roll into a head-down position.

If the procedure isn't successful, or if the baby moves back into a breech position, talk with a member of your health care team about the choices you have for delivery. Many babies in a complete or incomplete breech position are born by planned C-section.

When a baby is sideways — lying horizontal across the uterus, rather than vertical — it's called a transverse lie. In this position, the baby's back might be:

• Down, with the back facing the birth canal.
• Sideways, with one shoulder pointing toward the birth canal.
• Up, with the hands and feet facing the birth canal.

Although many babies are sideways early in pregnancy, few stay this way when labor begins.

If your baby is in a transverse lie during week 37 of your pregnancy, your health care professional may try to move the baby into a head-down position. This is done using a procedure called external cephalic version. External cephalic version involves one or two members of your health care team putting pressure on your belly with their hands to get the baby to roll into a head-down position.

If the procedure isn't successful, or if the baby moves back into a transverse lie, talk with a member of your health care team about the choices you have for delivery. Many babies who are in a transverse lie are born by C-section.

If you're pregnant with twins and only the twin that's lower in the uterus is head down, as shown below, your health care provider may first deliver that baby vaginally.

Then, in some cases, your health care team may suggest delivering the second twin in the breech position. Or they may try to move the second twin into a head-down position. This is done using a procedure called external cephalic version. External cephalic version involves one or two members of the health care team putting pressure on your belly with their hands to get the baby to roll into a head-down position.

Your health care team may suggest delivery by C-section for the second twin if:

• An attempt to deliver the baby in the breech position is not successful.
• You do not want to try to have the baby delivered vaginally in the breech position.
• An attempt to move the baby into a head-down position is not successful.
• You do not want to try to move the baby to a head-down position.

In some cases, your health care team may advise that you have both twins delivered by C-section. That might happen if the lower twin is not head down, the second twin has low or high birth weight as compared to the first twin, or if preterm labor starts.

• Landon MB, et al., eds. Normal labor and delivery. In: Gabbe's Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021. https://www.clinicalkey.com. Accessed May 19, 2023.
• Holcroft Argani C, et al. Occiput posterior position. https://www.updtodate.com/contents/search. Accessed May 19, 2023.
• Frequently asked questions: If your baby is breech. American College of Obstetricians and Gynecologists https://www.acog.org/womens-health/faqs/if-your-baby-is-breech. Accessed May 22, 2023.
• Hofmeyr GJ. Overview of breech presentation. https://www.updtodate.com/contents/search. Accessed May 22, 2023.
• Strauss RA, et al. Transverse fetal lie. https://www.updtodate.com/contents/search. Accessed May 22, 2023.
• Chasen ST, et al. Twin pregnancy: Labor and delivery. https://www.updtodate.com/contents/search. Accessed May 22, 2023.
• Cohen R, et al. Is vaginal delivery of a breech second twin safe? A comparison between delivery of vertex and non-vertex second twins. The Journal of Maternal-Fetal & Neonatal Medicine. 2021; doi:10.1080/14767058.2021.2005569.
• Marnach ML (expert opinion). Mayo Clinic. May 31, 2023.

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What Is Cephalic Position?

The ideal fetal position for labor and delivery

• Why It's Best

Risks of Other Positions

• Determining Position
• Turning a Fetus

The cephalic position is when a fetus is head down when it is ready to enter the birth canal. This is one of a few variations of how a fetus can rest in the womb and is considered the ideal one for labor and delivery.

About 96% of babies are born in the cephalic position. Most settle into it between the 32nd and 36th weeks of pregnancy . Your healthcare provider will monitor the fetus's position during the last weeks of gestation to ensure this has happened by week 36.

If the fetus is not in the cephalic position at that point, the provider may try to turn it. If this doesn't work, some—but not all—practitioners will attempt to deliver vaginally, while others will recommend a Cesarean (C-section).

Getty Images

Why Is the Cephalic Position Best?

During labor, contractions dilate the cervix so the fetus has adequate room to come through the birth canal. The cephalic position is the easiest and safest way for the baby to pass through the birth canal.

If the fetus is in a noncephalic position, delivery becomes more challenging. Different fetal positions have a range of difficulties and varying risks.

A small percentage of babies present in noncephalic positions. This can pose risks both to the fetus and the mother, and make labor and delivery more challenging. It can also influence the way in which someone can deliver.

A fetus may actually find itself in any of these positions throughout pregnancy, as the move about the uterus. But as they grow, there will be less room to tumble around and they will settle into a final position.

It is at this point that noncephalic positions can pose significant risks.

Cephalic Posterior

A fetus may also present in an occiput or cephalic posterior position. This means they are positioned head down, but they are facing the abdomen instead of the back.

This position is also nicknamed "sunny-side up."

Presenting this way increases the chance of a painful and prolonged delivery.

There are three different types of breech fetal positioning:

• Frank breech: The legs are up with the feet near the head.
• Footling breech: One or both legs is lowered over the cervix.
• Complete breech: The fetus is bottom-first with knees bent.

A vaginal delivery is most times a safe way to deliver. But with breech positions, a vaginal delivery can be complicated.

When a baby is born in the breech position, the largest part—its head—is delivered last. This can result in them getting stuck in the birth canal (entrapped). This can cause injury or death.

The umbilical cord may also be damaged or slide down into the mouth of the womb, which can reduce or cut off the baby's oxygen supply.

Some providers are still comfortable performing a vaginal birth as long as the fetus is doing well. But breech is always a riskier delivery position compared with the cephalic position, and most cases require a C-section.

Likelihood of a Breech Baby

You are more likely to have a breech baby if you:

• Go into early labor before you're full term
• Have an abnormally shaped uterus, fibroids , or too much amniotic fluid
• Are pregnant with multiples
• Have placenta previa (when the placenta covers the cervix)

Transverse Lie

In transverse lie position, the fetus is presenting sideways across the uterus rather than vertically. They may be:

• Down, with the back facing the birth canal
• With one shoulder pointing toward the birth canal
• Up, with the hands and feet facing the birth canal

If a transverse lie is not corrected before labor, a C-section will be required. This is typically the case.

Determining Fetal Position

Your healthcare provider can determine if your baby is in cephalic presentation by performing a physical exam and ultrasound.

In the final weeks of pregnancy, your healthcare provider will feel your lower abdomen with their hands to assess the positioning of the baby. This includes where the head, back, and buttocks lie

If your healthcare provider senses that the fetus is in a breech position, they can use ultrasound to confirm their suspicion.

Turning a Fetus So They Are in Cephalic Position

External cephalic version (ECV) is a common, noninvasive procedure to turn a breech baby into cephalic position while it's still in the uterus.

This is only considered if a healthcare provider monitors presentation progress in the last trimester and notices that a fetus is maintaining a noncephalic position as your delivery date approaches.

External Cephalic Version (ECV)

ECV involves the healthcare provider applying pressure to your stomach to turn the fetus from the outside. They will attempt to rotate the head forward or backward and lift the buttocks in an upward position. Sometimes, they use ultrasound to help guide the process.

The best time to perform ECV is about 37 weeks of pregnancy. Afterward, the fetal heart rate will be monitored to make sure it’s within normal levels. You should be able to go home after having ECV done.

ECV has a 50% to 60% success rate. However, even if it does work, there is still a chance the fetus will return to the breech position before birth.

Natural Methods For Turning a Fetus

There are also natural methods that can help turn a fetus into cephalic position. There is no medical research that confirms their efficacy, however.

• Changing your position: Sometimes a fetus will move when you get into certain positions. Two specific movements that your provider may recommend include: Getting on your hands and knees and gently rocking back and forth. Another you could try is pushing your hips up in the air while laying on your back with your knees bent and feet flat on the floor (bridge pose).
• Playing stimulating sounds: Fetuses gravitate to sound. You may be successful at luring a fetus out of breech position by playing music or a recording of your voice near your lower abdomen.
• Chiropractic care: A chiropractor can try the Webster technique. This is a specific chiropractic analysis and adjustment which enables chiropractors to establish balance in the pregnant person's pelvis and reduce undue stress to the uterus and supporting ligaments.
• Acupuncture: This is a considerably safe way someone can try to turn a fetus. Some practitioners incorporate moxibustion—the burning of dried mugwort on certain areas of the body—because they believe it will enhance the chances of success.

A Word From Verywell

While most babies are born in cephalic position at delivery, this is not always the case. And while some fetuses can be turned, others may be more stubborn.

This may affect your labor and delivery wishes. Try to remember that having a healthy baby, and staying well yourself, are your ultimate priorities. That may mean diverting from your best laid plans.

Speaking to your healthcare provider about turning options and the safest route of delivery may help you adjust to this twist and feel better about how you will move ahead.

Glezerman M. Planned vaginal breech delivery: current status and the need to reconsider . Expert Rev Obstet Gynecol. 2012;7(2):159-166. doi:10.1586/eog.12.2

Cleveland Clinic. Fetal positions for birth .

MedlinePlus. Breech birth .

UT Southwestern Medical Center. Can you turn a breech baby around?

The American College of Obstetricians and Gynecologists. If your baby is breech .

Roecker CB. Breech repositioning unresponsive to Webster technique: coexistence of oligohydramnios .  Journal of Chiropractic Medicine . 2013;12(2):74-78. doi:10.1016/j.jcm.2013.06.003

By Cherie Berkley, MS Berkley is a journalist with a certification in global health from Johns Hopkins University and a master's degree in journalism.

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

StatPearls [Internet].

Delivery, face and brow presentation.

Julija Makajeva ; Mohsina Ashraf .

Affiliations

Last Update: January 9, 2023 .

• Continuing Education Activity

Face and brow presentation is a malpresentation during labor when the presenting part is either the face or, in the case of brow presentation, it is the area between the orbital ridge and the anterior fontanelle. This activity reviews the evaluation and management of these two presentations and explains the interprofessional team's role in safely managing delivery for both the mother and the baby.

• Identify the mechanism of labor in the face and brow presentation.
• Differentiate potential maternal and fetal complications during the face and brow presentations.
• Evaluate different management approaches for the face and brow presentation.
• Introduction

The term presentation describes the leading part of the fetus or the anatomical structure closest to the maternal pelvic inlet during labor. The presentation can roughly be divided into the following classifications: cephalic, breech, shoulder, and compound. Cephalic presentation is the most common and can be further subclassified as vertex, sinciput, brow, face, and chin. The most common presentation in term labor is the vertex, where the fetal neck is flexed to the chin, minimizing the head circumference. Face presentation is an abnormal form of cephalic presentation where the presenting part is the mentum. This typically occurs because of hyperextension of the neck and the occiput touching the fetal back. Incidence of face presentation is rare, accounting for approximately 1 in 600 of all presentations. [1] [2] [3]  In brow presentation, the neck is not extended as much as in face presentation, and the leading part is the area between the anterior fontanelle and the orbital ridges. Brow presentation is considered the rarest of all malpresentation, with a prevalence of 1 in 500 to 1 in 4000 deliveries. [3]

Both face and brow presentations occur due to extension of the fetal neck instead of flexion; therefore, conditions that would lead to hyperextension or prevent flexion of the fetal neck can all contribute to face or brow presentation. These risk factors may be related to either the mother or the fetus. Maternal risk factors are preterm delivery, contracted maternal pelvis, platypelloid pelvis, multiparity, previous cesarean section, and black race. Fetal risk factors include anencephaly, multiple loops of cord around the neck, masses of the neck, macrosomia, and polyhydramnios. [2] [4] [5]  These malpresentations are usually diagnosed during the second stage of labor when performing a digital examination. Palpating orbital ridges, nose, malar eminences, mentum, mouth, gums, and chin in face presentation is possible. Based on the position of the chin, face presentation can be further divided into mentum anterior, posterior, or transverse. In brow presentation, the anterior fontanelle and face can be palpated except for the mouth and the chin. Brow presentation can then be further described based on the position of the anterior fontanelle as frontal anterior, posterior, or transverse. Diagnosing the exact presentation can be challenging, and face presentation may be misdiagnosed as frank breech. To avoid any confusion, a bedside ultrasound scan can be performed. [6]  Ultrasound imaging can show a reduced angle between the occiput and the spine or the chin is separated from the chest. However, ultrasound does not provide much predictive value for the outcome of labor. [7]

• Anatomy and Physiology

Before discussing the mechanism of labor in the face or brow presentation, it is crucial to highlight some anatomical landmarks and their measurements. 

Planes and Diameters of the Pelvis

The 3 most important planes in the female pelvis are the pelvic inlet, mid-pelvis, and pelvic outlet. Four diameters can describe the pelvic inlet: anteroposterior, transverse, and 2 obliques. Furthermore, based on the landmarks on the pelvic inlet, there are 3 different anteroposterior diameters named conjugates: true conjugate, obstetrical conjugate, and diagonal conjugate. Only the latter can be measured directly during the obstetric examination. The shortest of these 3 diameters is obstetrical conjugate, which measures approximately 10.5 cm and is the distance between the sacral promontory and 1 cm below the upper border of the symphysis pubis. This measurement is clinically significant as the fetal head must pass through this diameter during the engagement phase. The transverse diameter measures about 13.5 cm and is the widest distance between the innominate line on both sides. The shortest distance in the mid pelvis is the interspinous diameter and usually is only about 10 cm. 

Fetal Skull Diameters

There are 6 distinguished longitudinal fetal skull diameters:

• Suboccipito-bregmatic: from the center of anterior fontanelle (bregma) to the occipital protuberance, measuring 9.5 cm. This is the diameter presented in the vertex presentation. 
• Suboccipito-frontal: from the anterior part of bregma to the occipital protuberance, measuring 10 cm 
• Occipito-frontal: from the root of the nose to the most prominent part of the occiput, measuring 11.5 cm
• Submento-bregmatic: from the center of the bregma to the angle of the mandible, measuring 9.5 cm. This is the diameter in the face presentation where the neck is hyperextended. 
• Submento-vertical: from the midpoint between fontanelles and the angle of the mandible, measuring 11.5 cm 
• Occipito-mental: from the midpoint between fontanelles and the tip of the chin, measuring 13.5 cm. It is the presenting diameter in brow presentation. 

Cardinal Movements of Normal Labor

• Neck flexion
• Internal rotation
• Extension (delivers head)
• External rotation (restitution)
• Expulsion (delivery of anterior and posterior shoulders)

Some key movements are impossible in the face or brow presentations. Based on the information provided above, it is obvious that labor be arrested in brow presentation unless it spontaneously changes to the face or vertex, as the occipito-mental diameter of the fetal head is significantly wider than the smallest diameter of the female pelvis. Face presentation can, however, be delivered vaginally, and further mechanisms of face delivery are explained in later sections.

• Indications

As mentioned previously, spontaneous vaginal delivery can be successful in face presentation. However, the main indication for vaginal delivery in such circumstances would be a maternal choice. It is crucial to have a thorough conversation with a mother, explaining the risks and benefits of vaginal delivery with face presentation and a cesarean section. Informed consent and creating a rapport with the mother is an essential aspect of safe and successful labor.

• Contraindications

Vaginal delivery of face presentation is contraindicated if the mentum is lying posteriorly or is in a transverse position. In such a scenario, the fetal brow is pressing against the maternal symphysis pubis, and the short fetal neck, which is already maximally extended, cannot span the surface of the maternal sacrum. In this position, the diameter of the head is larger than the maternal pelvis, and it cannot descend through the birth canal. Therefore, the cesarean section is recommended as the safest mode of delivery for mentum posterior face presentations. Attempts to manually convert face presentation to vertex, manual or forceps rotation of the persistent posterior chin to anterior are contraindicated as they can be dangerous. Persistent brow presentation itself is a contraindication for vaginal delivery unless the fetus is significantly small or the maternal pelvis is large.

Continuous electronic fetal heart rate monitoring is recommended for face and brow presentations, as heart rate abnormalities are common in these scenarios. One study found that only 14% of the cases with face presentation had no abnormal traces on the cardiotocograph. [8]  External transducer devices are advised to prevent damage to the eyes. When internal monitoring is inevitable, monitoring devices on bony parts should be placed carefully. 

Consultations that are typically requested for patients with delivery of face/brow presentation include the following:

• Experienced midwife, preferably looking after laboring women 1:1
• Senior obstetrician 
• Neonatal team - in case of need for resuscitation 
• Anesthetic team - to provide necessary pain control (eg, epidural)
• Theatre team  - in case of failure to progress, an emergency cesarean section is required.
• Preparation

No specific preparation is required for face or brow presentation. However, discussing the labor options with the mother and birthing partner and informing members of the neonatal, anesthetic, and theatre co-ordinating teams is essential.

• Technique or Treatment

Mechanism of Labor in Face Presentation

During contractions, the pressure exerted by the fundus of the uterus on the fetus and the pressure of the amniotic fluid initiate descent. During this descent, the fetal neck extends instead of flexing. The internal rotation determines the outcome of delivery. If the fetal chin rotates posteriorly, vaginal delivery would not be possible, and cesarean section is permitted. The approach towards mentum-posterior delivery should be individualized, as the cases are rare. Expectant management is acceptable in multiparous women with small fetuses, as a spontaneous mentum-anterior rotation can occur. However, there should be a low threshold for cesarean section in primigravida women or women with large fetuses.

The pubis is described as mentum-anterior when the fetal chin is rotated towards the maternal symphysis. In these cases, further descent through the vaginal canal continues, with approximately 73% of cases delivering spontaneously. [9]  The fetal mentum presses on the maternal symphysis pubis, and the head is delivered by flexion. The occiput is pointing towards the maternal back, and external rotation happens. Shoulders are delivered in the same manner as in vertex delivery.

Mechanism of Labor in Brow Presentation

As this presentation is considered unstable, it is usually converted into a face or an occiput presentation. Due to the cephalic diameter being wider than the maternal pelvis, the fetal head cannot engage; thus, brow delivery cannot occur. Unless the fetus is small or the pelvis is very wide, the prognosis for vaginal delivery is poor. With persistent brow presentation, a cesarean section is required for safe delivery.

• Complications

As the cesarean section is becoming a more accessible mode of delivery in malpresentations, the incidence of maternal and fetal morbidity and mortality during face presentation has dropped significantly. [10]  However, some complications are still associated with the nature of labor in face presentation. Due to the fetal head position, it is more challenging for the head to engage in the birth canal and descend, resulting in prolonged labor. Prolonged labor itself can provoke fetal distress and arrhythmias. If the labor arrests or signs of fetal distress appear on CTG, the recommended next step in management is an emergency cesarean section, which in itself carries a myriad of operative and post-operative complications. Finally, due to the nature of the fetal position and prolonged duration of labor in face presentation, neonates develop significant edema of the skull and face. Swelling of the fetal airway may also be present, resulting in respiratory distress after birth and possible intubation.

• Clinical Significance

During vertex presentation, the fetal head flexes, bringing the chin to the chest, forming the smallest possible fetal head diameter, measuring approximately 9.5 cm. With face and brow presentation, the neck hyperextends, resulting in greater cephalic diameters. As a result, the fetal head engages later, and labor progresses more slowly. Failure to progress in labor is also more common in both presentations compared to the vertex presentation. Furthermore, when the fetal chin is in a posterior position, this prevents further flexion of the fetal neck, as browns are pressing on the symphysis pubis. As a result, descending through the birth canal is impossible. Such presentation is considered undeliverable vaginally and requires an emergency cesarean section. Manual attempts to change face presentation to vertex or manual or forceps rotation to mentum anterior are considered dangerous and discouraged.

• Enhancing Healthcare Team Outcomes

A multidisciplinary team of healthcare experts supports the woman and her child during labor and the perinatal period. For a face or brow presentation to be appropriately diagnosed, an experienced midwife and obstetrician must be involved in the vaginal examination and labor monitoring. As fetal anomalies, such as anencephaly or goiter, can contribute to face presentation, sonographers experienced in antenatal scanning should also be involved in the care. It is advised to inform the anesthetic and neonatal teams in advance of the possible need for emergency cesarean section and resuscitation of the neonate. [11] [12]

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Disclosure: Julija Makajeva declares no relevant financial relationships with ineligible companies.

Disclosure: Mohsina Ashraf declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

• Cite this Page Makajeva J, Ashraf M. Delivery, Face and Brow Presentation. [Updated 2023 Jan 9]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Why Is Cephalic Presentation Ideal For Childbirth?

5   Dec   2017 | 8 min Read

During labour, contractions stretch your birth canal so that your baby has adequate room to come through during birth. The cephalic presentation is the safest and easiest way for your baby to pass through the birth canal.

If your baby is in a non-cephalic position, delivery can become more challenging. Different fetal positions pose a range of difficulties and varying risks and may not be considered ideal birthing positions.

Two Kinds of Cephalic Positions

There are two kinds of cephalic positions:

• Cephalic occiput anterior , where your baby’s head is down and is facing toward your back.
• Cephalic occiput posterior , where your baby is positioned head down, but they are facing your abdomen instead of your back. This position is also nicknamed ‘sunny-side-up’ and can increase the chances of prolonged and painful delivery. 

How to Know if Your Baby is In a Cephalic Position?

You can feel your baby’s position by rubbing your hand on your belly. If you feel your little one’s stomach in the upper stomach, then your baby is in a cephalic position. But if you feel their kicks in the lower stomach, then it could mean that your baby is in a breech position.

You can also determine whether your baby is in the anterior or posterior cephalic position. If your baby is in the anterior position, you may feel their movement underneath your ribs and your belly button could also pop out. If your baby is in the posterior position, then you may feel their kicks in their abdomen, and your stomach may appear rounded up instead of flat. 

You can also determine your baby’s position through an ultrasound scan or a physical examination at your healthcare provider’s office. 

Benefits of Cephalic Presentation in Pregnancy

Cephalic presentation is one of the most ideal birth positions, and has the following benefits:

• It is the safest way to give birth as your baby’s position is head-down and prevents the risk of any injuries.
• It can help your baby move through the delivery canal as safely and easily as possible.
• It increases the chances of smooth labour and delivery.

Are There Any Risks Involved in Cephalic Position?

Conditions like a cephalic posterior position in addition to a narrow pelvis of the mother can increase the risk of pregnancy complications during delivery. Some babies in the head-first cephalic presentation might have their heads tilted backward. This may, in some rare cases, cause preterm delivery.

What are the Risks Associated with Other Birth Positions?

A small percentage of babies may settle into a non-cephalic position before their birth. This can pose risks to both your and your baby’s health, and also influence the way in which you deliver. 

In the next section, we have discussed a few positions that your baby can settle in throughout pregnancy, as they move around the uterus. But as they grow old, there will be less space for them to tumble around, and they will settle into their final position. This is when non-cephalic positions can pose a risk.  

Breech Position

There are three types of breech fetal positioning:

• Frank breech : Your baby’s legs stick straight up along with their feet near their head.
• Footling breech: One or both of your baby’s legs are lowered over your cervix.
• Complete breech: Your baby is positioned bottom-first with their knees bent.

If your baby is in a breech position , vaginal delivery is considered complicated. When a baby is born in breech position, the largest part of their body, that is, their head is delivered last. This can lead to injury or even fetal distress. Moreover, the umbilical cord may also get damaged or get wrapped around your baby’s neck, cutting off their oxygen supply.  

If your baby is in a breech position, your healthcare provider may recommend a c-section, or they may try ways to flip your baby’s position in a cephalic presentation.

Transverse Lie

In this position, your baby settles in sideways across the uterus rather than being in a vertical position. They may be:

• Head-down, with their back facing the birth canal
• One shoulder pointing toward the birth canal
• Up with their hands and feet facing the birth canal

If your baby settles in this position, then your healthcare provider may suggest a c-section to reduce the risk of distress in your baby and other pregnancy complications.

Turning Your Baby Into A Cephalic Position

External cephalic version (ECV) is a common, and non-invasive procedure that helps turn your baby into a cephalic position while they are in the womb. However, your healthcare provider may only consider this procedure if they consider you have a stable health condition in the last trimester, and if your baby hasn’t changed their position by the 36th week.

You can also try some natural remedies to change your baby’s position, such as:

• Lying in a bridge position: Movements like bridge position can sometimes help move your baby into a more suitable position. Lie on your back with your feet flat on the ground and your legs bent. Raise your pelvis and hips into a bridge position and hold for 5-10 minutes. Repeat several times daily.
• Chiropractic care: A chiropractor can help with the adjustment of your baby’s position and also reduce stress in them.
• Acupuncture: After your doctor’s go-ahead, you can also consider acupuncture to get your baby to settle into an ideal birthing position.

While most babies settle in a cephalic presentation by the 36th week of pregnancy, some may lie in a breech or transverse position before birth. Since the cephalic position is considered the safest, your doctor may recommend certain procedures to flip your baby’s position to make your labour and delivery smooth. You may also try the natural methods that we discussed above to get your baby into a safe birthing position and prevent risks or other pregnancy complications. 

When Should A Baby Be In A Cephalic Position?

Your baby would likely naturally drop into a cephalic position between weeks 37 to 40 of your pregnancy .

Is Cephalic Position Safe?

Research shows that 95% of babies take the cephalic position a few weeks or days before their due date. It is considered to be the safest position. It ensures a smooth birthing process.

While most of the babies are in cephalic position at delivery, this is not always the case. If you have a breech baby, you can discuss the available options for delivery with your doctor.

Does cephalic presentation mean labour is near?

Head-down is the ideal position for your baby within your uterus during birth. This is known as the cephalic position. This posture allows your baby to pass through the delivery canal more easily and safely.

Can babies change from cephalic to breech?

The external cephalic version (ECV) is the most frequent procedure used for turning a breech infant.

How can I keep my baby in a cephalic position?

While your baby naturally gets into this position, you can try some exercises to ensure that they settle in cephalic presentation. Exercises such as breech tilt, forward-leaning position (spinning babies program), cat and camel pose can help.

Stitches after a normal delivery : How many stitches do you need after a vaginal delivery? Tap this post to know.

Vaginal birth after caesarean delivery : Learn all about the precautions to consider before having a vaginal delivery after a c-section procedure. 

How many c-sections can you have : Tap this post to know the total number of c-sections that you can safely have.

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Fetal Presentation, Position, and Lie (Including Breech Presentation)

• Key Points |

Abnormal fetal lie or presentation may occur due to fetal size, fetal anomalies, uterine structural abnormalities, multiple gestation, or other factors. Diagnosis is by examination or ultrasonography. Management is with physical maneuvers to reposition the fetus, operative vaginal delivery , or cesarean delivery .

Terms that describe the fetus in relation to the uterus, cervix, and maternal pelvis are

Fetal presentation: Fetal part that overlies the maternal pelvic inlet; vertex (cephalic), face, brow, breech, shoulder, funic (umbilical cord), or compound (more than one part, eg, shoulder and hand)

Fetal position: Relation of the presenting part to an anatomic axis; for vertex presentation, occiput anterior, occiput posterior, occiput transverse

Fetal lie: Relation of the fetus to the long axis of the uterus; longitudinal, oblique, or transverse

Normal fetal lie is longitudinal, normal presentation is vertex, and occiput anterior is the most common position.

Abnormal fetal lie, presentation, or position may occur with

Fetopelvic disproportion (fetus too large for the pelvic inlet)

Fetal congenital anomalies

Uterine structural abnormalities (eg, fibroids, synechiae)

Multiple gestation

Several common types of abnormal lie or presentation are discussed here.

Transverse lie

Fetal position is transverse, with the fetal long axis oblique or perpendicular rather than parallel to the maternal long axis. Transverse lie is often accompanied by shoulder presentation, which requires cesarean delivery.

Breech presentation

There are several types of breech presentation.

Frank breech: The fetal hips are flexed, and the knees extended (pike position).

Complete breech: The fetus seems to be sitting with hips and knees flexed.

Single or double footling presentation: One or both legs are completely extended and present before the buttocks.

Types of breech presentations

Breech presentation makes delivery difficult ,primarily because the presenting part is a poor dilating wedge. Having a poor dilating wedge can lead to incomplete cervical dilation, because the presenting part is narrower than the head that follows. The head, which is the part with the largest diameter, can then be trapped during delivery.

Additionally, the trapped fetal head can compress the umbilical cord if the fetal umbilicus is visible at the introitus, particularly in primiparas whose pelvic tissues have not been dilated by previous deliveries. Umbilical cord compression may cause fetal hypoxemia.

Predisposing factors for breech presentation include

Preterm labor

Uterine abnormalities

Fetal anomalies

If delivery is vaginal, breech presentation may increase risk of

Umbilical cord prolapse

Birth trauma

Perinatal death

Face or brow presentation

In face presentation, the head is hyperextended, and position is designated by the position of the chin (mentum). When the chin is posterior, the head is less likely to rotate and less likely to deliver vaginally, necessitating cesarean delivery.

Brow presentation usually converts spontaneously to vertex or face presentation.

Occiput posterior position

The most common abnormal position is occiput posterior.

The fetal neck is usually somewhat deflexed; thus, a larger diameter of the head must pass through the pelvis.

Progress may arrest in the second phase of labor. Operative vaginal delivery or cesarean delivery is often required.

Position and Presentation of the Fetus

If a fetus is in the occiput posterior position, operative vaginal delivery or cesarean delivery is often required.

In breech presentation, the presenting part is a poor dilating wedge, which can cause the head to be trapped during delivery, often compressing the umbilical cord.

For breech presentation, usually do cesarean delivery at 39 weeks or during labor, but external cephalic version is sometimes successful before labor, usually at 37 or 38 weeks.

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Presentation and position of baby through pregnancy and at birth

9-minute read

If you are concerned about your baby’s movements, contact your doctor or midwife for advice immediately.

• If you baby is in a breech presentation, your doctor may recommend trying a technique called an external cephalic version to try and move your baby while they are still in the uterus for an easier birth.

What does presentation and position mean?

Presentation refers to the part of your baby’s body that is facing downwards in the direction of the birth canal.

Position refers to where your baby’s occiput (the bottom part of the back of their head) is in relation to your body.

If your baby is in a breech presentation , then position refers to where your baby’s sacrum (lower back) is in relation to your body.

People — including medical professionals — sometimes use these terms incorrectly. Sometimes when speaking about babies in breech presentation, the word ‘position’ will be used to refer to their presentation. For example, you may read information or hear people say ‘breech position’ instead of ‘breech presentation’.

What are the different types of presentation my baby could be in during pregnancy and birth?

Most babies present headfirst, also known as cephalic presentation. Most babies that are headfirst will be vertex presentation. This means that the crown of their head sits at the opening of your birth canal.

In rare cases, your baby can be headfirst but in face or brow presentation, which may not be suitable for vaginal birth.

If your baby is in a breech presentation, their feet or bottom will be closest to your birth canal. The 3 most common types of breech presentation are:

• frank or extended breech — where your baby’s legs are straight up in front of their body, with their feet up near their face
• complete or flexed breech — where your baby is in a sitting position with their legs crossed in front of their body and their feet near their bottom
• footling breech — where one or both of your baby’s feet are hanging below their bottom, so the foot or feet are coming first

Read more on breech presentation .

What are the different positions my baby could be in during pregnancy and birth?

If your baby is headfirst, the 3 main types of presentation are:

• anterior – when the back of your baby’s head is at the front of your belly
• lateral – when the back of your baby’s head is facing your side
• posterior – when the back of your baby’s head is towards your back

How will I know what presentation and position my baby is in?

Your doctor or midwife can usually work out your baby’s presentation by feeling your abdomen. They may also double check it with a portable ultrasound. Your baby’s presentation is usually checked around 36 weeks .

Your doctor or midwife will also confirm your baby’s head position in labour by examining your belly and using an ultrasound , and they may also do a vaginal examination . During the vaginal examination they are feeling for certain ridges on your baby’s head called sutures and fontanelles that help them work out which way your baby is positioned.

What is the ideal presentation and position for baby to be in for a vaginal birth?

For a vaginal birth, your baby will ideally be headfirst with the back of their head at the front of your belly, also known as being in the anterior position. This position is best for labour and birth since it means that the smallest part of your baby’s head goes down the birth canal first.

When does a baby usually get in the ideal presentation and position for birth?

Your baby will usually be in a headfirst position by 37 weeks of pregnancy. Around 3 in every 100 babies will be in breech presentation after 37 weeks.

Your baby’s position can change with your contractions during labour as they move down the birth canal, so their exact position can change during labour.

What are my options if baby isn't in the ideal presentation or position for a vaginal birth?

If your baby is in a breech presentation, your doctor may recommend a technique called an external cephalic version (ECV) to try and move your baby while they are still in the uterus . An ECV involves your doctor using their hands to apply pressure on your belly and help turn your baby to a headfirst position. It has a 1 in 2 chance of success and is a safe option in most pregnancies.

There is no evidence to show that alternative therapies, such as exercises, acupuncture or chiropractic treatments, help your baby change from a breech presentation to headfirst.

If your baby remains breech, your doctor may discuss having a breech vaginal birth. Not all doctors and hospitals offer this option. They may also suggest you birth your baby with a planned caesarean section .

If your baby’s presentation is headfirst but the position of your baby’s head is not ideal for labour, it can lead to a longer labour, and potential complications . The position of your baby’s head will often change as your labour progresses. If it doesn’t, sometimes you can still give birth without assistance, or you may need your doctor to help turn your baby’s head or help your birth with a vacuum or forceps .

Any procedure or decision for a type of birth will only go ahead with your consent . You will be able to discuss all the options with your doctor, and based on your preferences for yourself and your baby’s safety, make a decision together .

Resources and support

The Royal Australian and New Zealand College of Obstetrics and Gynaecology has a factsheet about the options available to you if your baby is in a breech presentation at the end of your pregnancy .

Mercy Perinatal has information on external cephalic version (ECV) safety and benefits if your baby is in a breech presentation at the end of your pregnancy.

The Women’s Hospital has information about the different presentations and positions your baby could be in, and how it can affect your birthing experience.

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Last reviewed: October 2023

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External cephalic version (ecv), malpresentation, breech pregnancy, search our site for.

• Foetal Version
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Breech presentation and turning the baby

In preparation for a safe birth, your health team will need to turn your baby if it is in a bottom first ‘breech’ position.

Read more on WA Health website

Breech Presentation at the End of your Pregnancy

Breech presentation occurs when your baby is lying bottom first or feet first in the uterus (womb) rather than the usual head first position. In early pregnancy, a breech position is very common.

Read more on RANZCOG - Royal Australian and New Zealand College of Obstetricians and Gynaecologists website

External Cephalic Version for Breech Presentation - Pregnancy and the first five years

This information brochure provides information about an External Cephalic Version (ECV) for breech presentation

Read more on NSW Health website

When a baby is positioned bottom-down late in pregnancy, this is called the breech position. Find out about 3 main types and safe birthing options.

Read more on Pregnancy, Birth & Baby website

Malpresentation is when your baby is in an unusual position as the birth approaches. It may be possible to move the baby, but a caesarean may be safer.

Labour complications

Even if you’re healthy and well prepared for childbirth, there’s always a chance of unexpected problems. Learn more about labour complications.

ECV is a procedure to try to move your baby from a breech position to a head-down position. This is performed by a trained doctor.

Having a baby

The articles in this section relate to having a baby – what to consider before becoming pregnant, pregnancy and birth, and after your baby is born.

Anatomy of pregnancy and birth - pelvis

Your pelvis helps to carry your growing baby and is tailored for vaginal births. Learn more about the structure and function of the female pelvis.

Planned or elective caesarean

There are important things to consider if you are having a planned or elective caesarean such as what happens during and after the procedure.

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Chapter 27:  Compound Presentations

George Tawagi

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Prolapse of hand and arm or foot and leg.

• MANAGEMENT OF COMPOUND PRESENTATIONS
• Full Chapter
• Supplementary Content

A presentation is compound when there is prolapse of one or more of the limbs along with the head or the breech, both entering the pelvis at the same time. Footling breech or shoulder presentations are not included in this group. Associated prolapse of the umbilical cord occurs in 15 to 20 percent of cases.

Easily detectable compound presentations occur probably once in 500 to 1000 confinements. It is impossible to establish the exact incidence because:

Spontaneous correction occurs frequently, and examination late in labor cannot provide the diagnosis

Minor degrees of prolapse are detected only by early and careful vaginal examination

Classification of Compound Presentation

Upper limb (arm–hand), one or both

Lower limb (leg–foot), one or both

Arm and leg together

Breech presentation with prolapse of the hand or arm

By far the most frequent combination is that of the head with the hand ( Fig. 27-1 ) or arm. In contrast, the head–foot and breech–arm groups are uncommon, about equally so. Prolapse of both hand and foot alongside the head is rare. All combinations may be complicated by prolapse of the umbilical cord, which then becomes the major problem.

FIGURE 27-1.

Compound presentation: head and hand.

The etiology of compound presentation includes all conditions that prevent complete filling and occlusion of the pelvic inlet by the presenting part. The most common causal factor is prematurity. Others include high presenting part with ruptured membranes, polyhydramnios, multiparity, a contracted pelvis, pelvic masses, and twins. It is also more common with inductions of labor involving floating presenting parts. Another predisposing factor is external cephalic version. During the process of external version, a fetal limb (commonly the hand–arm, but occasionally the foot) can become “trapped” before the fetal head and thus become the presenting part when labor ensues.

Diagnosis is made by vaginal examination, and in many cases, the condition is not noted until labor is well advanced and the cervix is fully dilated.

The condition is suspected when:

There is delay of progress in the active phase of labor

Engagement fails to occur

The fetal head remains high and deviated from the midline during labor, especially after the membranes rupture

In the absence of complications and with conservative management, the results should be no worse than with other presentations.

Mechanism of Labor

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Obstetric and Newborn Care I

10.02 key terms related to fetal positions.

a. “Lie” of an Infant.

Lie refers to the position of the spinal column of the fetus in relation to the spinal column of the mother. There are two types of lie, longitudinal and transverse. Longitudinal indicates that the baby is lying lengthwise in the uterus, with its head or buttocks down. Transverse indicates that the baby is lying crosswise in the uterus.

b. Presentation/Presenting Part.

Presentation refers to that part of the fetus that is coming through (or attempting to come through) the pelvis first.

(1) Types of presentations (see figure 10-1). The vertex or cephalic (head), breech, and shoulder are the three types of presentations. In vertex or cephalic, the head comes down first. In breech, the feet or buttocks comes down first, and last–in shoulder, the arm or shoulder comes down first. This is usually referred to as a transverse lie.

(2) Percentages of presentations.

(a) Head first is the most common-96 percent.

(b) Breech is the next most common-3.5 percent.

(c) Shoulder or arm is the least common-5 percent.

(3) Specific presentation may be evaluated by several ways.

(a) Abdominal palpation-this is not always accurate.

(b) Vaginal exam–this may give a good indication but not infallible.

(c) Ultrasound–this confirms assumptions made by previous methods.

(d) X-ray–this confirms the presentation, but is used only as a last resort due to possible harm to the fetus as a result of exposure to radiation.

c. Attitude.

This is the degree of flexion of the fetus body parts (body, head, and extremities) to each other. Flexion is resistance to the descent of the fetus down the birth canal, which causes the head to flex or bend so that the chin approaches the chest.

(1) Types of attitude (see figure 10-2).

(a) Complete flexion. This is normal attitude in cephalic presentation. With cephalic, there is complete flexion at the head when the fetus “chin is on his chest.” This allows the smallest cephalic diameter to enter the pelvis, which gives the fewest mechanical problems with descent and delivery.

(b) Moderate flexion or military attitude. In cephalic presentation, the fetus head is only partially flexed or not flexed. It gives the appearance of a military person at attention. A larger diameter of the head would be coming through the passageway.

(c) Poor flexion or marked extension. In reference to the fetus head, it is extended or bent backwards. This would be called a brow presentation. It is difficult to deliver because the widest diameter of the head enters the pelvis first. This type of cephalic presentation may require a C/Section if the attitude cannot be changed.

(d) Hyperextended. In reference to the cephalic position, the fetus head is extended all the way back. This allows a face or chin to present first in the pelvis. If there is adequate room in the pelvis, the fetus may be delivered vaginally.

(2) Areas to look at for flexion.

(a) Head-discussed in previous paragraph, 10-2c(1).

(b) Thighs-flexed on the abdomen.

(c) Knees-flexed at the knee joints.

(d) Arches of the feet-rested on the anterior surface of the legs.

(e) Arms-crossed over the thorax.

(3) Attitude of general flexion. This is when all of the above areas are flexed appropriately as described.

d. Station.

This refers to the depth that the presenting part has descended into the pelvis in relation to the ischial spines of the mother’s pelvis. Measurement of the station is as follows:

(1) The degree of advancement of the presenting part through the pelvis is measured in centimeters.

(2) The ischial spines is the dividing line between plus and minus stations.

(3) Above the ischial spines is referred to as -1 to -5, the numbers going higher as the presenting part gets higher in the pelvis (see figure10-3).

(4) The ischial spines is zero (0) station.

(5) Below the ischial spines is referred to +1 to +5, indicating the lower the presenting part advances.

e. Engagement.

This refers to the entrance of the presenting part of the fetus into the true pelvis or the largest diameter of the presenting part into the true pelvis. In relation to the head, the fetus is said to be engaged when it reaches the midpelvis or at a zero (0) station. Once the fetus is engaged, it (fetus) does not go back up. Prior to engagement occurring, the fetus is said to be “floating” or ballottable.

f. Position.

This is the relationship between a predetermined point of reference or direction on the presenting part of the fetus to the pelvis of the mother.

(1) The maternal pelvis is divided into quadrants.

(a) Right and left side, viewed as the mother would.

(b) Anterior and posterior. This is a line cutting the pelvis in the middle from side to side. The top half is anterior and the bottom half is posterior.

(c) The quadrants never change, but sometimes it is confusing because the student or physician’s viewpoint changes.

NOTE: Remember that when you are describing the quadrants, view them as the mother would.

(2) Specific points on the fetus.

(a) Cephalic or head presentation.

1 Occiput (O). This refers to the Y sutures on the top of the head.

2 Brow or fronto (F). This refers to the diamond sutures or anterior fontanel on the head.

3 Face or chin presentation (M). This refers to the mentum or chin.

(b) Breech or butt presentation.

1 Sacrum or coccyx (S). This is the point of reference.

2 Breech birth is associated with a higher perinatal mortality.

(c) Shoulder presentation.

1 This would be seen with a transverse lie.

2. Scapula (Sc) or its upper tip, the acromion (A) would be used for the point of reference.

(3) Coding of positions.

(a) Coding simplifies explaining the various positions.

1 The first letter of the code tells which side of the pelvis the fetus reference point is on (R for right, L for left).

2 The second letter tells what reference point on the fetus is being used (Occiput-O, Fronto-F, Mentum-M, Breech-S, Shoulder-Sc or A).

3 The last letter tells which half of the pelvis the reference point is in (anterior-A, posterior-P, transverse or in the middle-T).

(b) Each presenting part has the possibility of six positions. They are normally recognized for each position–using “occiput” as the reference point.

1 Left occiput anterior (LOA).

2 Left occiput posterior (LOP).

3 Left occiput transverse (LOT).

4 Right occiput anterior (ROA).

5. Right occiput posterior (ROP).

6 Right occiput transverse (ROT).

(c) A transverse position does not use a first letter and is not the same as a transverse lie or presentation.

1 Occiput at sacrum (O.S.) or occiput at posterior (O.P.).

2 Occiput at pubis (O.P.) or occiput at anterior (O.A.).

(4) Types of breech presentations (see figure10-4).

(a) Complete or full breech. This involves flexion of the fetus legs. It looks like the fetus is sitting in a tailor fashion. The buttocks and feet appear at the vaginal opening almost simultaneously.

A–Complete. B–Frank. C–Incomplete.

(b) Frank and single breech. The fetus thighs are flexed on his abdomen. His legs are against his trunk and feet are in his face (foot-in-mouth posture). This is the most common and easiest breech presentation to deliver.

(c) Incomplete breech. The fetus feet or knees will appear first. His feet are labeled single or double footing, depending on whether 1 or 2 feet appear first.

(5) Observations about positions (see figure 10-5).

(a) LOA and ROA positions are the most common and permit relatively easy delivery.

(b) LOP and ROP positions usually indicate labor may be longer and harder, and the mother will experience severe backache.

(c) Knowing positions will help you to identify where to look for FHT’s.

1 Breech. This will be upper R or L quad, above the umbilicus.

2 Vertex. This will be lower R or L quad, below the umbilicus.

(d) An occiput in the posterior quadrant means that you will feel lumpy fetal parts, arms and legs (see figure 10-5 A). If delivered in that position, the infant will come out looking up.

(e) An occiput in the anterior quadrant means that you will feel a more smooth back (see figure 10-5 B). If delivered in that position, the infant will come out looking down at the floor.

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Fetal Cephalic Presentation During Pregnancy

What Is Cephalic Position?

Types of cephalic position, benefits of cephalic presentation, risks of cephalic position, what are some other positions and their associated risks, when does a foetus get into the cephalic position, how do you know if baby is in cephalic position, how to turn a breech baby into cephalic position, natural ways to turn a baby into cephalic position.

If your baby is moving around in the womb, it’s a good sign as it tells you that your baby is developing just fine. A baby starts moving around in the belly at around 14 weeks. And their first movements are usually called ‘ quickening’ or ‘fluttering’.

A baby can settle into many different positions throughout the pregnancy, and it’s alright. But it is only when you have reached your third and final trimester that the position of your baby in your womb will matter the most. The position that your baby takes at the end of the gestation period will most likely be how your baby will make its appearance in the world. Out of all the different positions that your baby can settle into, the cephalic position at 36 weeks is considered the best position. Read on to learn more about fetal cephalic presentation.

When it comes to cephalic presentation meaning, the following can be considered. A baby is in the cephalic position when he is in a head-down position. This is the best position for them to come out in. In case of a ‘cephalic presentation’, the chances of a smooth delivery are higher. This position is where your baby’s head has positioned itself close to the birth canal, and the feet and bottom are up. This is the best position for your baby to be in for safe and healthy delivery.

Your doctor will begin to keep an eye on the position of your baby at around 34 weeks to 36 weeks . The closer you get to your due date, the more important it is that your baby takes the cephalic position. If your baby is not in this position, your doctor will try gentle nudges to get your baby in the right position.

Though it is pretty straightforward, the cephalic position actually has two types, which are explained below:

1. Cephalic Occiput Anterior

Most babies settle in this position. Out of all the babies who settle in the cephalic position, 95% of them will settle this way. This is when a baby is in the head-down position but is facing the mother’s back. This is the preferred position as the baby is able to slide out more easily than in any other position.

2. Cephalic Occiput Posterior

In this position, the baby is in the head-down position but the baby’s face is turned towards the mother’s belly. This type of cephalic presentation is not the best position for delivery as the baby’s head could get stuck owing to its wide position. Almost 5% of the babies in cephalic presentation settle into this position. Babies who come out in this position are said to come out ‘sunny side up’.

Cephalic presentation, where the baby’s head is positioned down towards the birth canal, is the most common and optimal fetal presentation for childbirth. This positioning facilitates a smoother delivery process for both the mother and the baby. Here are several benefits associated with cephalic presentation:

1. Reduced risk of complications

Cephalic presentation decreases the likelihood of complications during labor and delivery , such as umbilical cord prolapse or shoulder dystocia, which can occur with other presentations.

2. Easier vaginal delivery

With the baby’s head positioned first, vaginal delivery is generally easier and less complicated compared to other presentations, resulting in a smoother labor process for the mother.

3. Lower risk of birth injuries

Cephalic presentation reduces the risk of birth injuries to the baby, such as head trauma or brachial plexus injuries, which may occur with other presentations, particularly breech or transverse positions.

4. Faster progression of labor

Babies in cephalic presentation often help to stimulate labor progression more effectively through their positioning, potentially shortening the duration of labor and reducing the need for medical interventions.

5. Better fetal oxygenation

Cephalic presentation typically allows for optimal positioning of the baby’s head, which facilitates adequate blood flow and oxygenation, contributing to the baby’s well-being during labor and delivery.

Factors such as the cephalic posterior position of the baby and a narrow maternal pelvis can increase the likelihood of complications during childbirth. Occasionally, infants in the cephalic presentation may exhibit a backward tilt of their heads, potentially leading to preterm delivery in rare instances.

In addition to cephalic presentation, there are several other fetal positions that can occur during pregnancy and childbirth, each with its own associated risks. These positions can impact the delivery process and may require different management strategies. Here are two common fetal positions and their associated risks:

1. Breech Presentation

• Babies in breech presentation, where the buttocks or feet are positioned to enter the birth canal first, are at higher risk of birth injuries such as hip dysplasia or brachial plexus injuries.
• Breech presentation can lead to complications during labor and delivery, including umbilical cord prolapse, entrapment of the head, or difficulty delivering the shoulders, necessitating interventions such as cesarean section.

2. Transverse Lie Presentation

• Transverse lie , where the baby is positioned sideways across the uterus, often leads to prolonged labor and increases the likelihood of cesarean section due to difficulties in the baby’s descent through the birth canal.
• The transverse position of the baby may result in compression of the umbilical cord during labor, leading to decreased oxygen supply and potential fetal distress. This situation requires careful monitoring and intervention to ensure the baby’s well-being.

When a foetus is moving into the cephalic position, it is known as ‘head engagement’. The baby stars getting into this position in the third trimester, between the 32nd and the 36th weeks, to be precise. When the head engagement begins, the foetus starts moving down into the pelvic canal. At this stage, very little of the baby is felt in the abdomen, but more is felt moving downward into the pelvic canal in preparation for birth.

You may think that in order to find out if your baby has a cephalic presentation, an ultrasound is your only option. This is not always the case. You can actually find out the position of your baby just by touching and feeling their movements.

By rubbing your hand on your belly, you might be able to feel their position. If your baby is in the cephalic position, you might feel their kicks in the upper stomach. Whereas, if the baby is in the breech position, you might feel their kicks in the lower stomach.

Even in the cephalic position, it may be possible to tell if your baby is in the anterior position or in the posterior position. When your baby is in the anterior position, they may be facing your back. You may be able to feel your baby move underneath your ribs. It is likely that your belly button will also pop out.

When your baby is in the posterior position, you will usually feel your baby start to kick you in your stomach. When your baby has its back pressed up against your back, your stomach may not look rounded out, but flat instead.

Mothers whose placentas have attached in the front, something known as anterior placenta , you may not be able to feel the movements of your baby as well as you might like to.

Breech babies can make things complicated. Both the mother and the baby will face some problems. A breech baby is positioned head-up and bottom down. In order to deliver the baby, the birth canal needs to open a lot wider than it has to in the cephalic position. Besides this, your baby can get an arm or leg entangled while coming out.

If your baby is in the breech position, there are some things that you can do to encourage the baby to get into the cephalic position. There are a few exercises that could help such as pelvic tilts , swimming , spending a bit of time upside down, and belly dancing are a few ways you can try yourself to get your baby into the head-down position .

If this is not working either, your doctor will try an ECV (External Cephalic Version) . Here, your doctor will be hands-on, applying some gentle, but firm pressure to your tummy. In order to reach a cephalic position, the baby will need to be rolled into a bottom’s up position. This technique is successful around 50% of the time. When this happens, you will be able to have a normal vaginal delivery.

Though it sounds simple enough to get the fetal presentation into cephalic, there are some risks involved with ECV. If your doctor notices your baby’s heart rate starts to become problematic, the doctor will stop the procedure right away.

Encouraging a baby to move into the cephalic position, where the head is down towards the birth canal, is often desirable for smoother labor and delivery. While medical interventions may be necessary in some cases, there are natural methods that pregnant individuals can try to help facilitate this positioning. Here are several techniques that may help turn a baby into the cephalic position:

1. Optimal Maternal Positioning

Maintaining positions such as kneeling, hands and knees, or pelvic tilts may encourage the baby to move into the cephalic position by utilizing gravity and reducing pressure on the pelvis.

2. Spinning Babies Techniques

Specific exercises and positions recommended by the Spinning Babies organization, such as Forward-Leaning Inversion or the Sidelying Release, aim to promote optimal fetal positioning and may help encourage the baby to turn cephalic.

3. Chiropractic Care or Acupuncture

Some individuals find that chiropractic adjustments or acupuncture sessions with qualified practitioners can help address pelvic misalignment or relax tight muscles, potentially creating more space for the baby to maneuver into the cephalic position.

4. Prenatal Yoga and Swimming

Engaging in gentle exercises like prenatal yoga or swimming may help promote relaxation, reduce stress on the uterine ligaments, and encourage the baby to move into the cephalic position naturally. These activities also support overall physical and mental well-being during pregnancy.

1. What factors influence whether my baby will be in cephalic presentation?

Several factors can influence your baby’s position during pregnancy, including the shape and size of your uterus, the strength of your abdominal muscles, the amount of amniotic fluid, and the position of the placenta . Additionally, your baby’s own movements and preferences play a role.

2. Is it necessary for my baby to be in cephalic presentation for a vaginal delivery?

While cephalic presentation is considered the optimal position for vaginal delivery, some babies born in non-cephalic presentations can still be safely delivered vaginally with the guidance of a skilled healthcare provider. However, certain non-cephalic presentations may increase the likelihood of needing a cesarean section.

3. What can I do to encourage my baby to stay in the cephalic presentation?

Maintaining good posture, avoiding positions that encourage the baby to settle into a breech or transverse lie, staying active with gentle exercises, and avoiding excessive reclining can all help encourage your baby to remain in the cephalic presentation. Additionally, discussing any concerns with your healthcare provider and following their recommendations can be beneficial.

This was all about fetus with cephalic presentation. Most babies get into the cephalic position on their own. This is the most ideal situation as there will be little to no complications during normal vaginal labour. There are different cephalic positions, but these should not cause a lot of issues. If your baby is in any position other than cephalic in pregnancy, you may need C-Section . Keep yourself updated on the smallest of progress during your pregnancy so that you are aware of everything that is going on. Go for regular check-ups as your doctor will be able to help you if a complication arises during acephalic presentation at 20, 28 and 30 weeks.

References/Resources:

1. Glezerman. M; Planned vaginal breech delivery: current status and the need to reconsider (Expert Review of Obstetrics & Gynecology); Taylor & Francis Online; https://www.tandfonline.com/doi/full/10.1586/eog.12.2 ; January 2014

2. Feeling your baby move during pregnancy; UT Southwestern Medical Center; https://utswmed.org/medblog/fetal-movements/

3. Fetal presentation before birth; Mayo Clinic; https://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/in-depth/fetal-positions/art-20546850

4. Fetal Positions; Cleveland Clinic; https://my.clevelandclinic.org/health/articles/9677-fetal-positions-for-birth

5. FAQs: If Your Baby Is Breech; American College of Obstetricians and Gynecologists; https://www.acog.org/womens-health/faqs/if-your-baby-is-breech

6. Roecker. C; Breech repositioning unresponsive to Webster technique: coexistence of oligohydramnios (Journal of Chiropractic Medicine); Science Direct; https://www.sciencedirect.com/science/article/abs/pii/S1556370713000588 ; June 2013

7. Presentation and position of baby through pregnancy and at birth; Pregnancy, Birth & Baby; https://www.pregnancybirthbaby.org.au/presentation-and-position-of-baby-through-pregnancy-and-at-birth

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Cephalic presentation

A cephalic presentation or head presentation or head-first presentation is a situation at childbirth where the fetus is in a longitudinal lie and the head enters the pelvis first; the most common form of cephalic presentation is the vertex presentation where the occiput is the leading part (the part that first enters the birth canal). All other presentations are abnormal (malpresentations) which are either more difficult to deliver or not deliverable by natural means. Non-cephalic presentations are the breech presentation (3.5%) and the shoulder presentation (0.5%). In vertex presentations the head of the fetus most commonly faces to the right and slightly to the rear. This position is said to be the most usual one because the fetus is thus best accommodated to the shape of the uterus. In face presentation it may be necessary to turn the fetus before delivery if the chin is directed backward.

Bedside ultrasound can be employed to confirm the presentation and position of the fetal presenting part. Particular mention should be noted in the case of breech presentation due to its increased risks regarding fetal morbidity and mortality compared with the cephalic presenting fetus. In breech presentation the buttocks or the legs are the first to pass through the pelvis. The feet may be alongside the buttocks, or the legs may be extended against the face. Because the head is the last part of the fetus to be delivered in breech birth, there is some danger that the fetus will be asphyxiated; there is also danger that the umbilical cord will be compressed during birth of the head. About 25% of fetuses will be in breech presentation at 28 weeks, and this decreases to about 3% to 4% of term pregnancies 1 . Most of these patients will be delivered by cesarean delivery. Transverse presentation, which occurs only once in several hundred labors, requires turning of the fetus before vaginal delivery or else delivery by cesarean section.

The movement of the fetus to cephalic presentation is called head engagement. It occurs in the third trimester. In head engagement, the fetal head descends into the pelvic cavity so that only a small part (or none) of it can be felt abdominally. The perineum and cervix are further flattened and the head may be felt vaginally. Head engagement is known colloquially as the baby drop, and in natural medicine as the lightening because of the release of pressure on the upper abdomen and renewed ease in breathing. However, it severely reduces bladder capacity, increases pressure on the pelvic floor and the rectum, and the mother may experience the perpetual sensation that the fetus will “fall out” at any moment.

In the vertex presentation the head is flexed and the occiput leads the way. This is the most common configuration and seen at term in 95% of singletons. If the head is extended, the face becomes the leading part. Face presentations account for less than 1% of presentations at term. In the sinicipital presentation the large fontanelle is the presenting part; with further labor the head will either flex or extend more so that in the end this presentation leads to a vertex or face presentation. In the brow presentation the head is slightly extended, but less than in the face presentation. The chin presentation is a variant of the face presentation with maximum extension of the head.

Many factors determine the optimal way to deliver a baby. A vertex presentation is the ideal situation for a vaginal birth, however, occiput posterior positions tend to proceed more slowly, often requiring an intervention in the form of forceps, vacuum extraction, or Cesarean section 2 . In a large study, a majority of brow presentations were delivered by Cesarean section, however, because of ‘postmaturity’, factors other than labor dynamics may have played a role 3 . Most face presentations can be delivered vaginally as long as the chin is anterior; there is no increase in fetal or maternal mortality  4 . Mento-posterior positions cannot be delivered vaginally in most cases (unless rotated) and are candidates for Cesarean section in contemporary management 4 .

Vertex presentation

The vertex is the area of the vault bounded anteriorly by the anterior fontanelle and the coronal suture, posteriorly by the posterior fontanelle and the lambdoid suture and laterally by 2 lines passing through the parietal eminences.

In the vertex presentation the occiput typically is anterior and thus in an optimal position to negotiate the pelvic curve by extending the head. In an occiput posterior position, labor becomes prolonged and more operative interventions are deemed necessary. The prevalence of the persistent occiput posterior is given as 4.7%.

The vertex presentations are further classified according to the position of the occiput, it being right, left, or transverse, and anterior or posterior:

• Left Occipito-Anterior (LOA), Left Occipito-Posterior (LOP), Left Occipito-Transverse (LOT);
• Right Occipito-Anterior (ROA), Right Occipito-Posterior (ROP), Right Occipito-Transverse (ROT);

The Occipito-Anterior position is ideal for birth – it means that the baby is lined up so as to fit through the pelvis as easily as possible. The baby is head down, facing the spine, with its back anterior. In this position, the baby’s chin is tucked onto its chest, so that the smallest part of its head will be applied to the cervix first. The position is usually “Left Occiput Anterior”, or LOA. Occasionally, the baby may be “Right Occiput Anterior”, or ROA.

Figure 1. Vertex presentation

Face presentation

Factors that predispose to face presentation are prematurity, macrosomia, anencephaly and other malformations, cephalopelvic disproportion, and polyhydramnios 5 . In an uncomplicated face presentation duration of labor is not altered. Perinatal losses with face presentation occur with traumatic version and extraction and midforceps procedures. Duff 6 indicates that the prevalence of face presentations is about 1/500–600, while Benedetti et al. 7 found it to be 1/1,250 term deliveries.

Face presentations are classified according to the position of the chin (mentum):

• Left Mento-Anterior (LMA), Left Mento-Posterior (LMP), Left Mento-Transverse (LMT);
• Right Mento-Anterior (RMA), Right Mento-Posterior (RMP), Right Mento-Transverse (RMT);

Brow presentation

While some consider the brow presentation as an intermediate stage towards the face presentation, others disagree. Thus Bhal et al. indicated that both conditions are about equally common (1/994 face and 1/755 brow positions), and that prematurity was more common with face while postmaturity was more common with brow positions 3 .

Oskie presentation

The Oskie presentation is similar to the Occipito-Anterior position, where the baby is head down, facing the spine, with back on the ventral side of the uterus; however, in this position, while the torso is aligned with the mother’s longitudinal axis, the legs of the fetus are extended straight along the frontal axis of the mother, as if the baby is creating a right angle with its body. For the Oskie position to occur the baby’s head must be far down the pelvis in order to allow room for leg extension, typically the arms are bent, tucked against the baby’s body. There are no known complications for labor and delivery. This presentation is rare and is not well researched.

• Shanahan MM, Gray CJ. External Cephalic Version. [Updated 2019 Jun 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482475 [ ↩ ]
• [Effects of persistent occiput posterior presentation on mode of delivery]. Z Geburtshilfe Perinatol. 1994 Aug;198(4):117-9. https://www.ncbi.nlm.nih.gov/pubmed/7975796 [ ↩ ]
• A population study of face and brow presentation. J Obstet Gynaecol. 1998 May;18(3):231-5. https://www.ncbi.nlm.nih.gov/pubmed/15512065 [ ↩ ][ ↩ ]
• [Face presentation: retrospective study of 32 cases at term]. Gynecol Obstet Fertil. 2006 May;34(5):393-6. Epub 2006 Apr 21. https://www.ncbi.nlm.nih.gov/pubmed/16630740 [ ↩ ][ ↩ ]
• Face and brow presentation: independent risk factors. J Matern Fetal Neonatal Med. 2008 Jun;21(6):357-60. doi: 10.1080/14767050802037647. https://www.ncbi.nlm.nih.gov/pubmed/18570114 [ ↩ ]
• Diagnosis and management of face presentation. Obstet Gynecol. 1981 Jan;57(1):105-12. https://www.ncbi.nlm.nih.gov/pubmed/7005774 [ ↩ ]
• Face presentation at term. Obstet Gynecol. 1980 Feb;55(2):199-202. https://www.ncbi.nlm.nih.gov/pubmed/7352081 [ ↩ ]

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If Your Baby Is Breech

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In the last weeks of pregnancy, a fetus usually moves so his or her head is positioned to come out of the vagina first during birth. This is called a vertex presentation . A breech presentation occurs when the fetus’s buttocks, feet, or both are in place to come out first during birth. This happens in 3–4% of full-term births.

It is not always known why a fetus is breech. Some factors that may contribute to a fetus being in a breech presentation include the following:

You have been pregnant before.

There is more than one fetus in the uterus (twins or more).

There is too much or too little amniotic fluid .

The uterus is not normal in shape or has abnormal growths such as fibroids .

The placenta covers all or part of the opening of the uterus ( placenta previa )

The fetus is preterm .

Occasionally fetuses with certain birth defects will not turn into the head-down position before birth. However, most fetuses in a breech presentation are otherwise normal.

Your health care professional may be able to tell which way your fetus is facing by placing his or her hands at certain points on your abdomen. By feeling where the fetus's head, back, and buttocks are, it may be possible to find out what part of the fetus is presenting first. An ultrasound exam or pelvic exam may be used to confirm it.

External cephalic version (ECV) is an attempt to turn the fetus so that he or she is head down. ECV can improve your chance of having a vaginal birth. If the fetus is breech and your pregnancy is greater than 36 weeks your health care professional may suggest ECV.

ECV will not be tried if:

You are carrying more than one fetus

There are concerns about the health of the fetus

You have certain abnormalities of the reproductive system

The placenta is in the wrong place

The placenta has come away from the wall of the uterus ( placental abruption )

ECV can be considered if you have had a previous cesarean delivery .

The health care professional performs ECV by placing his or her hands on your abdomen. Firm pressure is applied to the abdomen so that the fetus rolls into a head-down position. Two people may be needed to perform ECV. Ultrasound also may be used to help guide the turning.

The fetus's heart rate is checked with fetal monitoring before and after ECV. If any problems arise with you or the fetus, ECV will be stopped right away. ECV usually is done near a delivery room. If a problem occurs, a cesarean delivery can be performed quickly, if necessary.

Complications may include the following:

Prelabor rupture of membranes

Changes in the fetus's heart rate

Placental abruption

Preterm labor

More than one half of attempts at ECV succeed. However, some fetuses who are successfully turned with ECV move back into a breech presentation. If this happens, ECV may be tried again. ECV tends to be harder to do as the time for birth gets closer. As the fetus grows bigger, there is less room for him or her to move.

Most fetuses that are breech are born by planned cesarean delivery. A planned vaginal birth of a single breech fetus may be considered in some situations. Both vaginal birth and cesarean birth carry certain risks when a fetus is breech. However, the risk of complications is higher with a planned vaginal delivery than with a planned cesarean delivery.

In a breech presentation, the body comes out first, leaving the baby’s head to be delivered last. The baby’s body may not stretch the cervix enough to allow room for the baby’s head to come out easily. There is a risk that the baby’s head or shoulders may become wedged against the bones of the mother’s pelvis. Another problem that can happen during a vaginal breech birth is a prolapsed umbilical cord . It can slip into the vagina before the baby is delivered. If there is pressure put on the cord or it becomes pinched, it can decrease the flow of blood and oxygen through the cord to the baby.

Although a planned cesarean birth is the most common way that breech fetuses are born, there may be reasons to try to avoid a cesarean birth.

A cesarean delivery is major surgery. Complications may include infection, bleeding, or injury to internal organs.

The type of anesthesia used sometimes causes problems.

Having a cesarean delivery also can lead to serious problems in future pregnancies, such as rupture of the uterus and complications with the placenta.

With each cesarean delivery, these risks increase.

If you are thinking about having a vaginal birth and your fetus is breech, your health care professional will review the risks and benefits of vaginal birth and cesarean birth in detail. You usually need to meet certain guidelines specific to your hospital. The experience of your health care professional in delivering breech babies vaginally also is an important factor.

Amniotic Fluid : Fluid in the sac that holds the fetus.

Anesthesia : Relief of pain by loss of sensation.

Breech Presentation : A position in which the feet or buttocks of the fetus would appear first during birth.

Cervix : The lower, narrow end of the uterus at the top of the vagina.

Cesarean Delivery : Delivery of a fetus from the uterus through an incision made in the woman’s abdomen.

External Cephalic Version (ECV) : A technique, performed late in pregnancy, in which the doctor attempts to manually move a breech baby into the head-down position.

Fetus : The stage of human development beyond 8 completed weeks after fertilization.

Fibroids : Growths that form in the muscle of the uterus. Fibroids usually are noncancerous.

Oxygen : An element that we breathe in to sustain life.

Pelvic Exam : A physical examination of a woman’s pelvic organs.

Placenta : Tissue that provides nourishment to and takes waste away from the fetus.

Placenta Previa : A condition in which the placenta covers the opening of the uterus.

Placental Abruption : A condition in which the placenta has begun to separate from the uterus before the fetus is born.

Prelabor Rupture of Membranes : Rupture of the amniotic membranes that happens before labor begins. Also called premature rupture of membranes (PROM).

Preterm : Less than 37 weeks of pregnancy.

Ultrasound Exam : A test in which sound waves are used to examine inner parts of the body. During pregnancy, ultrasound can be used to check the fetus.

Umbilical Cord : A cord-like structure containing blood vessels. It connects the fetus to the placenta.

Uterus : A muscular organ in the female pelvis. During pregnancy, this organ holds and nourishes the fetus.

Vagina : A tube-like structure surrounded by muscles. The vagina leads from the uterus to the outside of the body.

Vertex Presentation : A presentation of the fetus where the head is positioned down.

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Published: January 2019

Last reviewed: August 2022

Copyright 2024 by the American College of Obstetricians and Gynecologists. All rights reserved. Read copyright and permissions information . This information is designed as an educational aid for the public. It offers current information and opinions related to women's health. It is not intended as a statement of the standard of care. It does not explain all of the proper treatments or methods of care. It is not a substitute for the advice of a physician. Read ACOG’s complete disclaimer .

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• Volume 14, Issue 9
• Comparative effectiveness trial of metformin versus insulin for the treatment of gestational diabetes in the USA: clinical trial protocol for the multicentre DECIDE study
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• http://orcid.org/0000-0002-8043-556X Kartik K Venkatesh 1 ,
• Cora MacPherson 2 ,
• Rebecca G Clifton 3 ,
• Camille E Powe 4 ,
• Anna Bartholomew 5 ,
• Donna Gregory 1 ,
• Anne Trinh 6 ,
• Ann Scheck McAlearney 6 ,
• Lauren G Fiechtner 7 ,
• Patrick Catalano 8 ,
• Donna Rice 9 ,
• Sharon Cross 6 ,
• Huban Kutay 1 ,
• Steven Gabbe 10 ,
• William A Grobman 6 ,
• Maged M Costantine 6 ,
• Ashley N Battarbee 11 ,
• Kim Boggess 12 ,
• Vivek Katukuri 13 ,
• Kacey Eichelberger 14 ,
• Tania Esakoff 15 ,
• Maisa N Feghali 16 ,
• Lori Harper 17 ,
• Anjali Kaimal 18 ,
• Martha Kole-White 19 ,
• Hector Mendez-Figueroa 20 ,
• Malgorzata Mlynarczyk 21 ,
• Anthony Sciscione 22 ,
• Lydia Shook 4 ,
• Nasim C Sobhani 23 ,
• David M Stamilio 24 ,
• Erika Werner 25 ,
• Samantha Wiegand 26 ,
• Chloe A Zera 27 ,
• Noelia M Zork 28 ,
• George Saade 21 ,
• Mark B Landon 1
• 1 Department of Obstetrics and Gynecology , The Ohio State University , Columbus , Ohio , USA
• 2 Department of Epidemiology , George Washington University School of Public Health and Health Services , Washington , District of Columbia , USA
• 3 George Washington University School of Public Health and Health Services , Washington , District of Columbia , USA
• 4 Massachusetts General Hospital , Boston , Massachusetts , USA
• 5 College of Medicine , The Ohio State University , Columbus , Ohio , USA
• 6 The Ohio State University , Columbus , Ohio , USA
• 7 Mass General Hospital for Children , Boston , Massachusetts , USA
• 8 Department of Obstetrics and Gynecology , Tufts University , Medford , Oregon , USA
• 9 DiabetesSisters , Raleigh , North Carolina , USA
• 10 Ohio State University College of Medicine , Columbus , Ohio , USA
• 11 The University of Alabama , Birmingham , Alabama , USA
• 12 The University of North Carolina , Chapel Hill , North Carolina , USA
• 13 University of New Mexico School of Medicine , Albuquerque , New Mexico , USA
• 14 Prisma Health , Greenville , South Carolina , USA
• 15 Cedars-Sinai Medical Center , Los Angeles , California , USA
• 16 University of Pittsburgh , Pittsburgh , Pennsylvania , USA
• 17 The University of Texas , Austin , Texas , USA
• 18 University of South Florida , Tampa , Florida , USA
• 19 Brown University , Providence , Rhode Island , USA
• 20 The University of Texas Health Science Center , Houston , Texas , USA
• 21 EVMS , Norfolk , Virginia , USA
• 22 Christiana Care Health Services Inc , Wilmington , Delaware , USA
• 23 UCSF , San Francisco , California , USA
• 24 Wake Forest University School of Medicine , Winston-Salem , North Carolina , USA
• 25 Tufts Medical Center , Boston , Massachusetts , USA
• 26 Premier Health Miami Valley Hospital , Dayton , Ohio , USA
• 27 Department of Obstetrics and Gynecology , BIDMC , Boston , Massachusetts , USA
• 28 Columbia University Irving Medical Center , New York , New York , USA
• Correspondence to Dr Kartik K Venkatesh; kartik.venkatesh{at}osumc.edu

Introduction Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use.

Methods and analysis In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org .

Ethics and dissemination The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings.

Trial registration number NCT06445946 .

• Diabetes in pregnancy
• Clinical Trial
• Maternal medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2024-091176

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STRENGTHS AND LIMITATIONS OF THIS STUDY

DECIDE ( www.decidestudy.org ) is a patient-centred and pragmatic comparative-effectiveness randomised control trial that will compare oral metformin versus injectable insulin for the prevention of adverse pregnancy outcomes and the safety of postpartum outcomes among pregnant individuals with gestational diabetes mellitus who require pharmacotherapy and for their exposed children.

Strengths of the DECIDE trial include a non-inferiority clinical trial design, assessment of postpartum outcomes to confirm safety, integration of patient-reported outcomes and inclusion of a racially, ethnically and geographically diverse population.

Limitations of the DECIDE trial include no follow-up beyond 2 years post partum and assessment of participant and infant anthropometry and adiposity by physical exam instead of imaging.

Challenges of this trial will include recruitment across 20 US sites and postpartum retention.

Introduction

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy and affects nearly 400 000 or ~1 in 10 pregnant individuals in the USA every year. 1–3 The incidence of GDM has more than doubled in the past decade in an environment of rising prevalence of advanced reproductive age and obesity. 4 5 Moreover, GDM has risen inequitably among racially and ethnically minoritised and lower-income individuals. 2 6 More than one in four infants born to individuals with GDM will experience an adverse neonatal outcome, such as large-for-gestational age (LGA) birth weight, hypoglycaemia or hyperbilirubinaemia. 7–9 After delivery, individuals with prior GDM are at >10 fold increased risk of diabetes, and infants exposed to GDM are at 2-fold increased risk of obesity. 10 11

The goal of GDM treatment is to achieve optimal glycaemic control and prevent adverse pregnancy outcomes. 9 12 The initial therapeutic approach is dietary modification and regular exercise, 12 13 but >1 in 4 individuals will not achieve glucose control with these interventions. 13–15 When pharmacological treatment is needed, guidelines from the American Diabetes Association (ADA) and American College of Obstetricians and Gynecologists (ACOG) recommend insulin as the first-line medication, 14 16 while the Society for Maternal-Fetal Medicine states both insulin and metformin are reasonable medication options. 17

In the past, insulin has been the first-line option because it provides glycaemic control, improves pregnancy outcomes and does not cross the placenta. 7 18 19 An alternative to insulin is metformin, which also provides glycaemic control and improves pregnancy outcomes ( table 1 ). 18–20

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Advantages versus disadvantages of metformin versus insulin

Patients and providers may prefer metformin to insulin because it is convenient to take as an oral pill, well-tolerated, cheaper and practical when medication is needed for a brief time period. Additionally, metformin does not cause hypoglycaemia and reduces gestational weight gain. Metformin use is increasing in clinical practice—while insulin remains the most common medication for GDM, one in three individuals with GDM in the USA were prescribed metformin by late 2018. 21 22 Yet metformin has limitations, including that more than one in four individuals will ultimately need supplemental insulin to achieve glucose control, and there is known placental transfer. Historically, another oral agent, glyburide, had been used, but guidelines have since advised against its use following trials that showed it did not appear to be efficacious. 18 23

Follow-up data on metformin from individuals with prior GDM and their exposed children are limited. 24 Extant data suggest that children exposed to metformin had similar body fat composition but slightly higher body mass index (BMI) compared with those exposed to insulin 25 26 ; but recent population-based data show no difference in BMI. 27 However, these studies were limited due to inadequate randomised controlled trial (RCT) follow-up and observed heterogeneity in the effect across different study sites. Also, whether participant metabolic health postpartum varies based on prior metformin versus insulin exposure in pregnancy requires further study. 28

Deciding between metformin and insulin can be challenging for patients and providers given variation in treatment guidelines, provider recommendations and lack of conclusive comparative efficacy and safety data. 29 Understanding whether patients take medications as directed, how satisfied they are with their medication decision, and how their medication decision impacts their pregnancy experience may help to explain observed heterogeneity of treatment effects (HTE). 30 Patient perspectives on barriers to and facilitators of metformin versus insulin use may identify opportunities to improve outcomes. 31

DECIDE: A Comparative Effectiveness Trial of Oral Metformin vs Injectable Insulin for the Treatment of Gestational Diabetes is a randomised, patient-centred, open-label and pragmatic comparative effectiveness trial in pregnancy with postpartum follow-up. This protocol is written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. 32

Aims and hypotheses

Primary aims.

Aim 1: To evaluate whether pregnant individuals randomised to metformin are not inferior to pregnant individuals randomised to insulin for the composite adverse neonatal outcome (LGA birth weight, hypoglycaemia, hyperbilirubinemia or death).

Aim 2: To evaluate whether mean BMI at 2 years of age is higher in the offspring of pregnant individuals randomised to metformin.

Aim 3: To understand facilitators and barriers associated with metformin versus insulin use and HTE to facilitate evidence-based pharmacotherapy.

Primary hypotheses

Aim 1: We hypothesise that metformin is not inferior or worse than insulin by an absolute margin or difference of more than 8% in the composite adverse neonatal outcome.

Aim 2: We hypothesise that metformin does not result in increased child BMI at 2 years (not inferior by an absolute margin of 0.31 kg/m 2 ) compared with insulin.

Aim 3: We hypothesise that patient-reported factors associated with metformin compared with insulin use will be different, which is important to identify to enable clinical implementation of study findings.

Secondary aims

We will compare outcomes at delivery between pregnant individuals randomised to metformin versus insulin (hypertensive disorder of pregnancy, gestational weight gain, mode of delivery and obstetric anal sphincter injuries) and their infants (preterm birth, mechanical ventilation, neonatal intensive care unit (NICU) admission, oxygen support, respiratory distress syndrome and small-for-gestational-age at birth); as well as the frequency of treatment supplementation with insulin among pregnant individuals randomised to metformin.

We will compare outcomes at 2 years post partum between individuals randomised to metformin versus insulin (obesity, anthropometry, adiposity, diabetes, cholesterol and hypertension) and their children (obesity, anthropometry and adiposity).

We will compare patient-reported outcomes (PROs) at randomisation (mental and physical health; Diabetes Knowledge Questionnaire (DKQ), Diabetes Distress Scale (DDS) and Diabetes Management Self-Efficacy Scale (DMSES); lifestyle; health behaviours and diet), and at 6 weeks and 2 years post partum for the individual (pregnancy and childbirth experiences; treatment adherence and satisfaction; Maternal-Infant Bonding Scale (MIBS); lactation practices; lifestyle; health behaviours and diet) and child (lifestyle; health behaviours and diet).

Methods and analysis

DECIDE is a randomised, controlled, open-label, patient-centred and pragmatic multicentre comparative effectiveness trial that is designed to determine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed pregnant individuals and children and to identify patient-reported factors associated with metformin versus insulin that facilitate and enable implementation of study findings ( online supplemental file 1 ).

Supplemental material

The DECIDE Study Consortium includes 20 clinical sites under a clinical coordinating centre (CCC) and an independent data coordinating centre (DCC). The consortium is governed by a steering committee and guided by a patient advisory board and stakeholder engagement group. Data management, coordination and analysis will be completed by the DCC, led by the study statisticians (CM and RGC). Participant data will be collected, stored and maintained in OpenClinica, a browser-independent electronic data capture system. Enrolled individuals will be randomised in a 1:1 ratio of metformin to insulin within the web-based data management system according to a computer-generated permuted block design with variable block sizes. Randomisation will be stratified by study site.

Individuals will be recruited across 20 US clinical sites with diabetes and prenatal care programmes ( figure 1 ). These sites have been selected with the goal of achieving racial and ethnic, urban and rural, and geographical diversity at both academic and community-based medical centres. Individuals who continue to receive routine prenatal care in their local community, and then receive high-risk prenatal and diabetes care from the clinical site will also be eligible for study participation. After delivery, individuals and their infants will be followed up with data ascertainment at 6 weeks and 2 years post partum.

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Geographic distribution of DECIDE sites across the USA. CCC, clinical coordinating centre; DCC, data coordinating centre.

Inclusion criteria

Inclusion criteria are age >18 years, singleton pregnancy, gestational age between 20 0/7 and 31 6/7 weeks, GDM diagnosis between 20 0/7 and 31 6/7 weeks, requiring medication for glycaemic control, and willingness and ability to attend 2-year follow-up visit ( table 2 ). The decision to initiate medication will be consistent with current US recommendations, defined as ≥30% elevation of either fasting or 1-hour or 2-hour postprandial glucose values in the prior week.

Inclusion and exclusion criteria

Exclusion criteria

We will exclude individuals who have known underlying chronic kidney disease; a fetus with a chromosomal, genetic or major structural malformation; contraindication to metformin or insulin; pregestational diabetes (either type 1 or 2); early-onset GDM <20 weeks; prior haemoglobin A1c >6.5%; concurrent enrollment in a trial with a primary aim that influences the primary study outcome; planned delivery at an outside clinical site where access to medical records cannot be obtained for outcome data abstraction; language barrier (appropriate translation resources unavailable at the site); participation in this trial in a previous pregnancy and fasting hyperglycaemia defined as >115 mg/dL for ≥50% glucose values in the past week ( table 2 ). We include fasting hyperglycaemia as an exclusion criterion as prior data suggest that individuals with this finding are likely to require insulin to achieve glycaemic control. 20

Recruitment

The start date for recruitment is 1 August 2024 and is anticipated to end by 1 May 2026, with final data collection at the 2-year follow-up ending on 1 May 2028. All individuals who present for prenatal care at sites in the DECIDE Study Consortium will be screened for eligibility. Individuals who meet study criteria will be approached for participation by study staff, which will include a study pamphlet with a weblink and QR code ( www.decidestudy.org ) and a 3 min video about GDM medication management ( https://youtu.be/CGmYCmF4vDo ). After eligibility is confirmed, individuals will be asked to participate after study information is given. Individuals who agree will complete the written informed consent process (see online supplemental file 2 for sample consent document). Reasons for ineligibility and rates of declining to participate will be collected. The patient advisory board will review recruitment and retention materials to create participant-friendly information and to assist with provider trainings. 33

Pregnancy (aim 1)

Baseline visit.

A research team member or healthcare provider will ask patients if they are interested in joining the study either in person or virtually. Those who are interested will be given an orientation to the study by a research team member ( figure 2 ). Written informed consent will be obtained in English or Spanish. Enrolled individuals will be randomised in a 1:1 ratio to metformin or insulin. Study staff will inform the provider about randomisation arm via telephone, email and the electronic medical record. Because this is an open label, non-blinded pragmatic trial comparing two treatments that are standard of care, individuals allocated to either arm will obtain their medication from their preferred pharmacy with a prescription from their provider, which will account for brand of insulin on formularies of their insurance plans.

Flow diagram of DECIDE study events.

Using defined data fields, we will record participant demographics, medical history and obstetric characteristics. Participants will complete standardised surveys at randomisation to assess lifestyle, health behaviours, diet, mental and physical health during pregnancy, DKQ, DDS and DMSES.

Follow-up visits

Consistent with a pragmatic trial, all dosing changes will be performed by the participant’s provider. The frequency of participant clinical encounters will be about every 2 weeks, which is standard clinical practice for GDM management, 34 with virtual or in-person clinic visits at the discretion of the provider. Study staff will visit with participants monthly (preferably in person and otherwise virtually), ask them about adherence to assigned treatment, review side effects related to their medication including nausea and symptoms of hypoglycaemia and assess medication adherence. Additionally, study staff will review and abstract the following information from the participant’s medical record: capillary blood glucose log values or continuous glucose monitoring logs for the past 1 week period, current metformin and insulin dosing, type(s) of insulin, and gestational weight gain. Finally, study staff will assess for adverse events (AEs) and serious AEs (SAEs) at each study visit.

The assigned treatment (insulin vs metformin) will be discontinued at delivery. The provider will have the responsibility for intrapartum and postpartum management. Data on intrapartum and postpartum glycaemic management will be abstracted by the study team. 35 Additionally, participant and infant data will be collected from the EHR until hospital discharge. We will collect comprehensive antepartum and intrapartum data, such as labour and delivery details; glycaemic control and neonatal outcomes. To address concerns about placental transfer of medication and fetal safety, cord blood and placental samples will be collected when possible for further analyses.

Postpartum follow-up through 2 years (aim 2)

~6 weeks post partum.

At ~6–8 weeks post partum, participants will complete standardised surveys with the study team in person, by a virtual platform, or by mail, per participant and site preference. This visit will include standardised measures to assess treatment adherence and satisfaction, lactation, lifestyle, health behaviours, diet, pregnancy and childbirth experience, and MIBS. Additional participant and child postpartum data through the ~6 weeks postpartum visit will be collected from the EHR. Testing for diabetes at the postpartum visit is standard of care. We will collect these results and emphasise best practices to increase uptake of diabetes screening. 36 Research staff will actively maintain contact with participants every 6 months after delivery by telephone, email or post.

2-years post partum

At or after 2 years post partum, participants will be invited to return for an in-person assessment and physical exam of both the participant and child. Participants will complete standardised surveys to assess lifestyle, health behaviours and diet in the mother and child. Physical exam of the child will include growth (weight and height), anthropometry (arm and abdominal circumference) and adiposity (skinfolds) measurements. For the participant, blood pressure, height, weight, anthropometry (waist and hip circumferences) and adiposity (skinfolds) will be obtained. The assessor at the visit will be masked to study arm assignment. A calibrated scale with stadiometer will be used for weight and height, a tape measure for anthropometry and callipers for skinfold measurements. As has been done in prior GDM cohorts (co-I PC), all sites will undergo central training and assessment in these techniques to promote standardisation of measurements and adherence to the study protocol. 37 38 Ongoing training and strict monitoring of the study team measurement techniques will be performed and regular assessment of interobserver variation will be conducted via training videos every 6 months. For the postpartum individual, blood will be obtained using standard venipuncture techniques, including for haemoglobin A1c, cholesterol panel and 2-hour 75 g oral glucose tolerance test using standardised collection procedures. 39

Mixed-methods assessment (aim 3)

In years 2–4 of the study, 150 individuals across all sites will be invited to complete a 30–45 min interview approximately 6 weeks after delivery. Individuals will be purposefully recruited from each study site and across each year of the study to ensure diversity with respect to race and ethnicity, age, insurance status and study arm. Participants will be given the option to be interviewed by phone or via video (eg, zoom).

A semistructured interview guide has been developed and refined based on feedback from patients and experts on qualitative research methods ( online supplemental file 2 ). These interviews will be performed centrally at OSU under the supervision of co-I ASM. The guide will include open-ended questions in the following domains: DECIDE trial participation, GDM and pregnancy, medications to treat GDM, experiences taking medication to treat GDM, and GDM and postpartum health. 31 During the interviews, participants will be asked to describe their experiences using metformin and/or insulin with question probes to address specific aspects of their experiences, including barriers to and facilitators of metformin and insulin use, and the factors that might improve adherence and pregnancy experience. The draft guide will be pilot tested and finalised prior to use in the study. All interviews will be audio recorded and transcribed verbatim to allow rigorous qualitative analysis.

Patient and public involvement

Patient and stakeholder interactions have helped develop the research question, comparators, study participants characteristics and relevant outcomes. 31 The DECIDE investigator team will engage key opinion leaders, patients with a history of GDM or living with diabetes and stakeholders, including public and private-sector insurers, advocacy organisations and professional societies, to elicit feedback through the Patient Advisory Board (co-I SC) and Stakeholder Engagement Board (co-I AT), both of which were established for this study and DiabetesSisters (co-I DR), a national patient advocacy organisation dedicated to women living with diabetes. The team will draw on participatory learning approaches, such as adaptive management, rapid assessments, data-driven decision-making and human-centred design to codevelop recommendations to inform project improvement.

The outcomes in this study include both clinical outcomes and PROs that cumulatively measure obstetric and perinatal morbidity and mortality that impact quality of life, well-being and pregnancy experience. Clinical outcomes relevant to contemporary practice are based on prior GDM pharmacotherapy trials, 20 23 40 meta-analyses comparing treatment strategies for GDM to prevent adverse outcomes, 18 19 26 engagement with stakeholder organisations and providers, 41 and core outcome sets for GDM that used a Delphi methodology. 42 43 PROs 44 are based on validated and standardised instruments that address birth experiences, living with diabetes, and treatment experiences and adherence; systematic reviews of prior qualitative studies of patient experiences with GDM; and testimonials from affected individuals and their families. 29 30 45–47

Primary clinical outcomes

The primary pregnancy outcome (aim 1) is a neonatal composite adverse outcome of LGA birth weight, hypoglycaemia, hyperbilirubinaemia and/or death ( table 3 ). 48 This measure is based on neonatal outcomes causally related to glycaemic control and consistent with that used in recent trials 23 and meta-analyses. 19

Primary and secondary outcomes

In the follow-up at 2 years, the primary child outcome is BMI as a continuous measure, which is consistent with prior GDM RCT follow-up studies and meta-analyses. 18 19 40 An updated sex-adjusted US reference will be used for standardisation of height and weight for age. 49 Anthropometry will be measured with standardised protocols that have been successfully implemented in prior GDM cohorts at birth (co-I PC). 37 38 50

Secondary clinical outcomes

Secondary pregnancy outcomes ( table 3 ) include neonatal outcomes (preterm birth, small-for-gestational-age, NICU admission, mechanical ventilation by duration, oxygen support by type and duration, and respiratory distress syndrome by clinical features and oxygen or respiratory support for any time during the first 72 hours after birth and participant outcomes (hypertensive disorder of pregnancy, mode of delivery, total gestational weight gain and obstetric anal sphincter injuries).

In the follow-up at 2 years, secondary child outcomes include obesity and measures of adiposity and anthropometry. Secondary participant outcomes at 2 years will include type 2 diabetes, obesity, pre-diabetes, hypertension, metabolic profile, and measures of anthropometry and adiposity.

Patient-reported measures

At randomisation, baseline assessments will include mental and physical health (PROMIS Global Short Form 51 52 ; DKQ, 53 DDS, 54 DMSES 55 and social determinants of health (Accountable Health Communities Health-Related Social Needs Screening Tool 56 and Williams Everyday Discrimination Scale 57 ( table 3 ).

At ~6 weeks postpartum follow-up visit, PROs will include treatment adherence and satisfaction Treatment Satisfaction Questionnaire for Medication 58 and Acceptability of Treatment 20 ; infant feeding practices (CDC Infant Feeding Practices, selected questions) 59 ; pregnancy and childbirth experience (Birth Satisfaction Scale-Revised Indicator) 60 ; MIBS 61 ; International Physical Activity Questionnaire (IPAQ), short-form 62 ; Mini-EAT (Eating Assessment Tool) 63 and the Brief Infant Sleep Questionnaire-Revised Short Form (selected questions). 64

At 2 years, PROs of the postpartum individual will include IPAQ, long-form 62 ; Mini-EAT 63 ; social determinants of health 56 ; mental and physical health 51 and of the child will include CDC Child Health and Diet Survey (selected questions) 65 ; Movement Behaviour Questionnaire (selected questions) 66 ; Brief Infant Sleep Questionnaire-Revised Short Form (selected questions) 64 and the Child Eating Behaviour Questionnaire. 67

Pharmacotherapy management

Study guidelines for metformin and insulin management including initiation, dosing, titration and monitoring have been developed based on current clinical guidelines. 68 Pharmacotherapy will be initiated when ≥30% of fasting and/or postprandial glucose values are elevated in the past week. Given this is a pragmatic trial, clinical practice may vary slightly across sites based on local standard-of-care and individualised provider–patient decision-making.

Treatment initiation and titration

Metformin (either extended or immediate release) will be started at 500 mg two times per day and titrated to a maximum daily dose of 2500 mg. Participants randomised to metformin will be given uniform advice by study personnel on how to minimise gastrointestinal distress, such as taking study tablets prior to meals and using antiemetics.

Providers will be encouraged to use trimester-specific and weight-based insulin dosing criteria for both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some participants may be managed with a single dose of intermediate-acting or long-acting insulin at night to treat isolated fasting hyperglycaemia, while others may require additional treatment of postprandial hyperglycaemia with shorter-acting insulin. The sites’ insulin formularies may include rapid (Novolog, Humalog and Aspart), intermediate (Humulin N, Novolin N and NPH) and long-acting insulins (detemir, Lantus and degludec) with comparable efficacy in pregnancy. Participant insurance coverage will be considered when selecting insulin type.

We will standardise the incorporation of best practices regarding metformin and insulin titration per ADA and ACOG guidelines. Providers at each site will be instructed on the study protocol and trained on study procedures, including glycaemic monitoring ~1–2 weeks and uptitration. Glucose assessment by those participants electing self-monitored blood glucose monitoring will be performed at fasting and three times postprandial; those who elect continuous glucose monitoring will be asked to similarly document their fasting and postprandial values. Adherence to these goals will be monitored by research staff monthly from participant interviews and medical record review. Concerns regarding protocol adherence will be discussed with site PIs. Weekly participant glucose logs and total metformin and insulin doses and type of insulin will be recorded and considered in data analysis.

Treatment supplementation

Participants receiving metformin will have insulin supplemented (ie, addition of insulin to base regimen of metformin) only if they have not achieved euglycaemia for at least 30% of glucose values after approaching the maximum daily dose of metformin (>2000 mg or the maximum tolerated dose). Participants will be asked to continue taking metformin after treatment supplementation with insulin, which is generally the current clinical practice. In rare circumstances (0%–2%) in which severe gastrointestinal distress or intolerable side effects are present with metformin, participants may be prescribed insulin before reaching the maximum daily dose of metformin (2500 mg) or switched to insulin entirely. 69 Reasons that patients and providers decide on treatment supplementation will be collected.

Data safety and monitoring

An independent data safety monitoring board (DSMB) has been created to provide oversight of trial accrual and of privacy and safety of study participants. DSMB members have appropriate expertise (obstetrics and gynaecology, maternal–fetal medicine, endocrinology, neonatology, bioethics and biostatistics). The DSMB will meet to review the protocol prior to study initiation and then yearly to review study progress. The DCC will provide reports to the DSMB that include recruitment, protocol adherence and safety outcomes.

Detailed information about AEs and SAEs will be collected and evaluated throughout the trial. If a patient develops an SAE, the primary clinician in collaboration with the site PI will ascertain the safety of continuing the intervention. All unanticipated and possibly study-related AEs and SAEs will be reported to the IRB per regulatory reporting guidelines. Metformin may be temporarily stopped in the setting of acute kidney injury or intravenous contrast administration. Metformin has been reported to be very rarely associated with lactic acidosis (<10 cases per 100 000 patient-years), although the validity of this association has been challenged. 70 We will include lactic acidosis on metformin as a safety stopping rule.

Statistical analysis plan

Sample size and power.

Published data suggest that upwards of 30% of individuals with GDM have an associated adverse neonatal outcome. Using data from recent meta-analyses that compared the two treatment regimens, 18 19 71 and the most recent RCT (although comparing glyburide to insulin) that assessed the same primary composite outcome as in our study, 23 we estimate the frequency of the primary composite perinatal outcome to be 28% with insulin. To be conservative, we have used an estimate of 25%.

We have chosen a non-inferiority trial design because metformin’s advantages in terms of cost and ease (eg, oral, no refrigeration needed, less costly) suggest that metformin may be the preferred first-line treatment for GDM if it were found to be non-inferior to insulin in terms of efficacy and safety. 41 A non-inferiority margin of 8% was selected for the primary outcome based on a survey and interviews we conducted in January to June 2021 with each of our 20 site PIs, all of whom are maternal-fetal medicine specialists, as well as interviews with 144 patients. This conservative margin is also consistent with recent non-inferiority RCTs for GDM. 23 Additionally, we estimate that 20% of individuals who are randomised to metformin will require supplemental insulin, 21 which is lower than prior trials because we will exclude those with fasting hyperglycaemia (>115 mg/dL for >50% in the prior week) who are at the highest risk of failing metformin. 20

Based on the above assumptions, we plan to enrol 1572 individuals to determine if metformin is non-inferior to insulin for the composite primary outcome, with 90% power, one-sided significance level of 0.025, a loss to follow-up at delivery of 2% and 20% supplementation with insulin in addition to metformin.

For the 2-year follow-up, if outcomes are obtained on 1415 participants (ie, a loss to follow-up rate of 10%), there will be 90% power to rule out an effect size of at least 0.172 SD. This translates to a 0.31 unit difference in BMI or a 0.29 kg mean difference in child weight. 25 There will be 80% power to rule out an effect size of at least 0.149 SD, or a 0.27 unit difference in BMI or a 0.25 kg mean difference.

Analyses for pregnancy outcomes (aim 1)

We will use descriptive statistics to characterise participants to determine comparability of treatment groups at baseline. As an intention-to-treat analysis, the comparison is between individuals randomised to start metformin regardless of whether they later required supplemental insulin or stopped metformin due to side effects and switched to insulin versus individuals randomised to start on insulin. Analyses of the primary outcome will consist of summarising the proportions of trial participants with the primary endpoint for each group and calculating the corresponding between-group risk difference (insulin minus metformin) with 95% CIs.

Data analyses will adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines and follow the intention-to-treat principle in which patients are analysed in the group to which they were randomised, regardless of whether they received the assigned intervention or altered their assigned medication prior to delivery. Metformin will be determined as non-inferior if the lower 95% confidence limit for the risk difference is −8 percentage points or greater (ie, closer to 0). If treatment groups differ on a pretreatment factor known to be a risk factor for the outcome, the analysis will adjust for these differences and an adjusted risk difference will be reported. If metformin is determined to be non-inferior to insulin, a superiority test will be conducted without adjusting the type I error, with metformin considered superior if the lower 95% confidence limit for the risk difference is more than 0.

Interim analyses

Since the sample size estimate is based on the assumption that the primary endpoint rate will be 25% in the insulin group, it is important to evaluate this proportion in the study after 20% of the participants (N=315) have delivered. In addition, the proportion of patients in the metformin group who require supplemental insulin will be reported. Once 50% of the participants have delivered (N=786), a formal interim analysis will be performed to determine whether metformin is inferior to insulin, with an upper boundary for the stopping rule for harm based on a one-sided type I error of 0.025 and the Lan-DeMets generalisation of the O’Brien-Fleming boundary. If the upper confidence bound for the risk difference is less than 0, the DSMB will evaluate this in the context of the other safety outcomes. We also plan to calculate conditional power given the observed data and conditional on future data showing no difference between treatment strategies. If the conditional power is high (>90%) that the neonatal composite rate will be more that 8% higher in the metformin arm, the DSMB will consider termination for futility, although any decision to terminate the study would not be reached solely on statistical grounds but on a number of clinical and statistical considerations.

Analyses for postpartum follow-up through 2 years (aim 2)

Child BMI is the primary outcome at 2 years of age. Analyses will consist of summarising the mean BMI standardised for age and sex for each group and calculating the corresponding between-group mean difference with 95% CIs using generalised linear models. Metformin will be determined as non-inferior to insulin if the lower 95% confidence limit for the mean difference is 0.31 units or greater (ie, closer to 0). Additional analyses as detailed above for the primary neonatal composite in the RCT will be performed, including for measures of child adiposity and anthropometry. Fetal sex will be evaluated for predefined interaction analyses with treatment group, and anthropometry will be standardised by sex-specific standards. 48

Mixed-methods analyses (aim 3)

We will use the constant comparative method and a grounded theory approach to analyse interview data. 72 This iterative approach to analysis will include reading interview transcripts and discussing findings among investigators as the study progresses. Our approach will enable exploration of emergent themes and ensure saturation in data collection. Analysis will prioritise the elucidation of key concepts from individuals’ interview statements (extraction), conceptual development based on constant comparative analysis, and classification of data through code development. 72 73 The coding team (co-I ASM) will create a preliminary coding dictionary based on the interview guide, defining broad categories of findings to enable coding of responses to interview questions. Frequent discussions among coding team members will allow the characterisation of emergent codes and ensure agreement about identified themes and subthemes. ATLAS.ti software will be used to support the analysis process.

Subgroup analyses

Treatment effectiveness for subgroups may differ due to barriers related to social determinants of health (eg, race/ethnicity), bioavailability of medication, physiologic insulin resistance (eg, BMI) or factors related to GDM and its severity (eg, maternal age, gestational age at medication initiation) ( online supplemental file 3 ). We will employ existing rigorous checklist for addressing the design, analysis and context of subgroup analyses. 74 These risk factors were selected based on differences in the frequency of GDM and adverse pregnancy and postpartum outcomes, and hence, at least a theoretical possibility as to why HTE may exist. We will formally assess for effect modification (interaction effect). Should we note significant heterogeneity of treatment effect across these prespecified groups (p<0.05), we will then systematically examine two-way effect modification. Should there be evidence of HTE, the proposed exploratory subgroup analyses will employ a non-inferiority approach consistent with the overall trial design and analysis plan.

Missing data and sensitivity analyses

We will investigate the robustness of the observed differences between the two groups with respect to any missing data. First, an inverse probability weighting (IPW) analysis will be conducted with each case weighted by the inverse probability of being a complete case. Under a missing-at-random mechanism, the IPW approach would result in an unbiased estimate of the difference between groups assuming a correctly specified model for the missing data. Second, a tipping-point analysis will describe the additional number of events in the insulin group versus the metformin group among the participants with missing data that would change the conclusion related to non-inferiority. In addition, a sensitivity analysis will be performed among participants in the metformin group who did not require supplemental insulin versus participants randomised to insulin only.

Participants will be asked to provide contact information (eg, phone, email and address) for themselves and two relatives who would know how to contact them. Research staff will actively maintain contact with participants throughout their pregnancies and by telephone, email or post, every 6 months after delivery. Participants will be asked to verify or update information at each contact. We will also maintain contact with participants and their families through flyers, cards and electronic communications in order to provide study updates.

Compensation

Participant reimbursement will be provided for completing assessments at multiple time points: randomisation (US$100), 6 weeks post partum (in person, virtual and/or telephone) (US$50) and 2-year follow-up visits for the participant and child (in person) (US$125). Participants selected for qualitative interviews will receive additional compensation (US$100).

Ethics and dissemination

The OSU Institutional Review Board (IRB), which will serve as the single IRB of record for all sites, has approved this protocol. All protocol amendments will be communicated for approval to the OSU IRB. Before a site may start the trial, it must be certified, which involves certification of research staff and an IRB reliance agreement with the single IRB.

We will submit study results for publication in peer-reviewed journals. The DCC and CCC will maintain access to the final trial dataset, and a limited deidentified dataset will be released via the online portal of the primary funder. A key component of our dissemination plan will be increasing patient and provider awareness about the comparative effectiveness results. Our partnership with DiabetesSisters and the Stakeholder Engagement Group will be leveraged for dissemination of results, including appropriate forums (eg, meetings, newsletters, social media communities, online videos). We will share accessible evidence-based factsheets and provide our primary publications for free download, including to study participants.

In this two-arm, open-label, pragmatic, comparative effectiveness RCT, we will examine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed mothers and children, and whether patient-reported factors including facilitators and barriers of medication use differ between metformin versus insulin use. The DECIDE trial will randomise 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites—with uniform diagnostic and treatment criteria—to oral metformin versus injectable insulin and follow them and their children through delivery and then to 2 years post partum.

The proposed comparative effectiveness study is designed to inform one of the most frequent medication decisions in pregnancy. The clinical equipoise that currently exists in use of these medications for GDM underscores that a trial with pregnancy and postpartum follow-up in a diverse, representative and contemporary US population is necessary and will fill a key knowledge gap affecting everyday practice, patient experience and clinical outcomes. 41 These themes, listed in bold below, have been identified as critical by stakeholders including patients, providers, researchers and professional societies.

Fill a critical evidence gap with regard to the optimal pharmacotherapy for individuals with GDM to prevent adverse pregnancy outcomes

Among the major limitations of the RCTs to date are (1) using varying GDM diagnostic criteria, (2) unclear criteria or guidelines for supplemental insulin, (3) lack of sufficient power for important outcomes, (4) insufficient long-term assessment of outcomes in exposed children, (5) unreported patterns of hyperglycaemia potentially influencing treatment effectiveness and (6) results from populations that do not reflect a contemporary US population. DECIDE will address each of these limitations with uniform diagnostic and treatment criteria and inclusion of 20 academic and community centres representative of major US geographical regions with diverse population characteristics.

Identify the long-term outcomes of metformin versus insulin on pregnant person and child health

Experts have cautioned that a GDM treatment trial without a plan for robust postnatal follow-up will not meaningfully fill the evidence gap and allow best practices to be determined. 24 71 DECIDE embeds a seamless, preplanned and rigorous follow-up of all randomised mother–child dyads.

Characterise patient experiences of individuals with GDM requiring pharmacotherapy

An in-depth understanding of patient and other key stakeholder perspectives on barriers to and facilitators of metformin versus insulin use is necessary to identify opportunities to improve outcomes. DECIDE includes PROs and outcomes that focus on the same constructs to bolster patient and stakeholder confidence. 75 DECIDE also assesses patient experiences, such as medication side effects, whether patients take medicines as directed, how satisfied they are with their medication choice, and how their medication choice impacts their pregnancy and postpartum experience, which may explain observed HTEs.

Active patient and stakeholder engagement

The proposed study is designed with the goal of informing healthcare decisions, both by filling an important evidence gap and by ensuring that the evidence provided is aligned with and informed by patients and other healthcare partners. While conducting the study, we will engage with the patient advisory board and stakeholder engagement group, which includes patients, patient advocates, clinicians, researchers, purchasers, payors, industry, health systems and policy-makers. We will discuss the study protocol and startup in a cooperative learning environment, and these stakeholders will be invited to participate in data analysis to add their perspectives to promote authenticity.

Limitations and strengths

Limitations.

First, while randomisation to pharmacotherapy minimises selection bias, lack of patient and provider blinding to treatment can introduce bias. Second, because this is a pragmatic RCT, variations in insulin formulary and differences in medication titration may result in heterogeneity in outcomes. To minimise the impact of variation of treatment effects across study sites, we have instituted uniform criteria for treatment initiation, defined as ≥30% elevated glucose values in the prior week. Also, the DECIDE manual of operations will contain guidelines for insulin and metformin management and standardised glycaemic targets for medication titration. We will stratify randomisation by site, and we will consider adjustment for site in analyses via both stratification and interaction effects. Finally, we include follow-up through 2 years postpartum, although longer follow-up may be necessary to assess the long-term impact of pharmacotherapy on outcomes.

We have powered our study to a conservative non-inferiority margin, which is consistent with recent non-inferiority RCTs for GDM 23 and allows for substitution of supplemental insulin for those on metformin. Second, we examine postpartum safety following exposure to metformin versus insulin on child and maternal/paternal health. Third, we integrate rigorous assessment of patient preferences and values through PROs, standardised measures and qualitative interviews as part of the RCT and follow-up. Finally, DECIDE includes a racially, ethnically and geographically diverse patient population with broad inclusion criteria reflective of obstetric practice to maximise relevance, impact and generalisability.

Ethics statements

Patient consent for publication.

Not applicable.

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Contributors KKV, CM, RGC, GS and ML designed the study. KKV, CM, RGC, AB, DG and ML wrote the methods manuscript. CP, ASM, LF, PC, AT and DR provided oversight for study design and implementation. CM and RGC provided statistical support and oversight. Under the clinical oversight of KKV, ML, MC, ANB, KB, KE, TE, MNF, LH, AK, MK-W, HM-F, MM, AS, NS, DS, SW, and CAZ assisted with the clinical trial development and execution. All authors revised the manuscript for relevant scientific content and approved the final version of the manuscript.

Funding This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) BPS-2022C3-30268.

Disclaimer All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.

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Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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