Breech PresentationNCT04538261
Elevation of the Fetal Buttocks Prior to External Cephalic Version
A study testing Fetal Pillow insertion in people with Breech Presentation and External Cephalic Version, run by AdventHealth at 1 site in United States.
Trial summary
This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breech Presentation, External Cephalic Version
- What is being tested?
- Fetal Pillow insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women delivering at AdventHealth Orlando campus.
- Breech presenting part as diagnosed by bedside sonography.
- No prior deliveries >/= 20 weeks gestational age.
- Pregnancy is between 37-40 weeks gestational age.
- Live fetus.
- Patient is >/= age 18.
- Patient speaks English or Spanish as primary language.
- Patient able to understand verbal and written consent
Who cannot join
- Non-breech presentation (cephalic, transverse, oblique).
- More than 1 fetus.
- Cervical dilation of >/= 1cm.
- Prior uterine incision.
- Congenital uterine anomaly.
- Body mass index more than 40 kg/m2.
Show all 17Show fewer
- Uterine fibroids causing soft tissue dystocia.
- Extended fetal neck.
- Oligohydramnios (4-quadrant amniotic fluid index </= 5cm).
- Spontaneous rupture of membranes.
- Any contraindication to vaginal delivery.
- Intrauterine growth restriction (estimated fetal weight </= 10%ile).
- Estimated fetal weight > /= 5,000 grams for non-diabetic patient or >/= 4,500 grams for patient with pre-existing or gestational diabetes, confirmed by ultrasound.
- Fetal gastroschisis.
- Fetal neural tube defect.
- Severe-range preeclampsia.
- Patient had regional anesthesia immediately prior to ECV.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures. Eligible study population: nulliparous pregnant women between 37-40 weeks estimated gestational age with a breech presenting fetus and no contraindications to external cephalic version.
Read the detailed description
Patients meeting inclusion criteria will be offered participation in this study. After performing an obstetric sonogram to determine fetal position, amniotic fluid status, fetal weight and placental location, the patient will be randomized to either placement of the Fetal Pillow balloon device with sham inflation (control arm) or placement of the device with inflation (study arm).
The researcher will show the patient the device, open the sterile container, and insert the device into the vagina per manufacturer's guidelines for all patients in the study. All patients will mark a line on a 100mm VAS to assess pre-insertion and post-insertion pain. The study physician will then obtain the assistance of a certified nurse midwife to inflate the device or perform a sham inflation. In order for the physician investigator to remain blinded, the physician will leave the room during the time of the inflation/sham inflation. A certified nurse midwife previously trained to inflate the device will perform the inflation or sham inflation per randomization. The assisting midwife will inflate the device with 180 mL of saline for those patients randomized to inflation. This will occur under a sheet so that the patient is blinded to the randomization scheme. If the patient is randomized to no inflation, the midwife will perform a sham inflation, also under a sheet. All patients will mark a line on a 100mm VAS to assess post-inflation/sham inflation pain. The assisting midwife then leaves the room, and the study physician reenters the room and proceeds with the external cephalic version (ECV) procedure.
Regardless of randomization, at this point the ECV procedure proceeds using normal routine. The ECV will be attempted up to four times and VAS will be assessed after each attempt. Once completed, all patients will also mark a line on a 100mm VAS to assess post-ECV pain.
The research physician will then remove the Fetal Pillow. Regardless of randomization, the procedure is completed per the usual routine of fetal monitoring, assessing for rupture of membranes, labor or bleeding, discussing post-procedure care, then discharge home (or, less likely, admitting for either observation or delivery).
The researcher will fill out the ECV portion of the data collection form. Data are collected later for delivery outcomes and costs for the mother and neonate.
- Conditions
- Breech Presentation, External Cephalic Version
- Being tested
- Fetal Pillow insertion
- Keywords
- Breech, Version
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Pillow insertionDevice
Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Non-inflation of the balloon device Receives: Device: Fetal Pillow insertion |
| Intervention | Experimental | Inflation of the balloon device Receives: Device: Fetal Pillow insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Having Successful Conversion to Cephalic Presentation
Successful conversion of breech fetus to cephalic presentation
Measured: Immediately upon completion of the ECV procedure
Secondary outcomes (14)
Cesarean Delivery
Presence of cesarean delivery
Measured: Immediately after ECV procedure or during subsequent labor and delivery
Fetal Presentation at Time of Delivery
Cephalic presentation of the fetus during participant delivery
Measured: Labor and Delivery (approximately 12 hours)
Cost of ECV Procedure and Hospital Stay (Mother)
Cost of ECV procedure and hospital stay (mother)
Measured: ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)
Cost of ECV Procedure and Hospital Stay (Neonate)
Cost of neonate's hospitalization after delivery
Measured: Birth to hospital discharge (up to 42 days)
Shoulder Dystocia
Presence of shoulder dystocia during delivery
Measured: Labor and Delivery (approximately 12 hours)
Rupture of Membranes
Presence of rupture of membranes after ECV procedure
Measured: Within 1 hour of ECV procedure
Emergency Cesarean Delivery
Need for emergency cesarean delivery during or after ECV procedure
Measured: During or within 1 hour of performing ECV procedure
Pelvic Hematoma
Development of a pelvic hematoma within 1 hour of ECV procedure
Measured: During or within 1 hour of performing ECV procedure
Procedural Pain During Device Insertion
Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Measured: Within 2 minutes after insertion of balloon device.
Number of Attempts
Number of attempted ECV procedures to convert fetus from breech to cephalic presentation
Measured: Immediately after ECV procedure
Cost of Hospital Stay for ECV Procedure
Total cost of the hospital stay for the ECV procedure
Measured: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)
Procedural Pain Prior to Device Insertion.
Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Measured: Within 3 minutes prior to insertion of device.
Procedural Pain After Inflation of Device or Sham Inflation.
Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Measured: Within 1 minute after device inflation or sham inflation.
Pain After External Cephalic Version Attempt.
Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Measured: Within 2 minutes of ECV procedure completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Nov 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: Not recruiting at the rate we thought it would.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial using control and interventional arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A Hill, MD, Principal investigator, AdventHealthAriana Mora, Study director, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538261
- Sponsor's protocol ID
- 1379199
- Status last verified
- Dec 2024
- First submitted
- 17 Aug 2020
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared outside of research team.
Publications
External Cephalic Version: ACOG Practice Bulletin, Number 221. Obstet Gynecol. 2020 May;135(5):e203-e212. doi: 10.1097/AOG.0000000000003837.
PubMed 32332415Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j.ijgo.2015.09.019. Epub 2016 Jan 15.
PubMed 26868074Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3.
PubMed 25828903Kok M, Cnossen J, Gravendeel L, van der Post J, Opmeer B, Mol BW. Clinical factors to predict the outcome of external cephalic version: a metaanalysis. Am J Obstet Gynecol. 2008 Dec;199(6):630.e1-7; discussion e1-5. doi: 10.1016/j.ajog.2008.03.008. Epub 2008 May 23.
PubMed 18456227Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: 10.1097/01.AOG.0000295605.38175.7b.
PubMed 18055730
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevation of the Fetal Buttocks Prior to External Cephalic Version
- ClinicalTrials.gov ID
- NCT04538261
- Acronym / sponsor ID
- 1379199
- Conditions
- Breech Presentation, External Cephalic Version
- Keywords
- Breech, Version
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not recruiting at the rate we thought it would.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures. Eligible study population: nulliparous pregnant women between 37-40 weeks estimated gestational age with a breech presenting fetus and no contraindications to external cephalic version.
Detailed description
Patients meeting inclusion criteria will be offered participation in this study. After performing an obstetric sonogram to determine fetal position, amniotic fluid status, fetal weight and placental location, the patient will be randomized to either placement of the Fetal Pillow balloon device with sham inflation (control arm) or placement of the device with inflation (study arm).
The researcher will show the patient the device, open the sterile container, and insert the device into the vagina per manufacturer's guidelines for all patients in the study. All patients will mark a line on a 100mm VAS to assess pre-insertion and post-insertion pain. The study physician will then obtain the assistance of a certified nurse midwife to inflate the device or perform a sham inflation. In order for the physician investigator to remain blinded, the physician will leave the room during the time of the inflation/sham inflation. A certified nurse midwife previously trained to inflate the device will perform the inflation or sham inflation per randomization. The assisting midwife will inflate the device with 180 mL of saline for those patients randomized to inflation. This will occur under a sheet so that the patient is blinded to the randomization scheme. If the patient is randomized to no inflation, the midwife will perform a sham inflation, also under a sheet. All patients will mark a line on a 100mm VAS to assess post-inflation/sham inflation pain. The assisting midwife then leaves the room, and the study physician reenters the room and proceeds with the external cephalic version (ECV) procedure.
Regardless of randomization, at this point the ECV procedure proceeds using normal routine. The ECV will be attempted up to four times and VAS will be assessed after each attempt. Once completed, all patients will also mark a line on a 100mm VAS to assess post-ECV pain.
The research physician will then remove the Fetal Pillow. Regardless of randomization, the procedure is completed per the usual routine of fetal monitoring, assessing for rupture of membranes, labor or bleeding, discussing post-procedure care, then discharge home (or, less likely, admitting for either observation or delivery).
The researcher will fill out the ECV portion of the data collection form. Data are collected later for delivery outcomes and costs for the mother and neonate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized trial using control and interventional arms.
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Fetal Pillow insertionNon-inflation of the balloon device |
| Intervention | Experimental | Device: Fetal Pillow insertionInflation of the balloon device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women delivering at AdventHealth Orlando campus.
- Breech presenting part as diagnosed by bedside sonography.
- No prior deliveries >/= 20 weeks gestational age.
- Pregnancy is between 37-40 weeks gestational age.
- Live fetus.
Key exclusion criteria (17 listed)
- Non-breech presentation (cephalic, transverse, oblique).
- More than 1 fetus.
- Cervical dilation of >/= 1cm.
- Prior uterine incision.
- Congenital uterine anomaly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Pillow insertionInflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure | Device | Control, Intervention |
Primary outcome
Number of Participants Having Successful Conversion to Cephalic Presentation
Time frame: Immediately upon completion of the ECV procedure
Successful conversion of breech fetus to cephalic presentation
14 secondary outcomes
Cesarean Delivery
Time frame: Immediately after ECV procedure or during subsequent labor and delivery
Fetal Presentation at Time of Delivery
Time frame: Labor and Delivery (approximately 12 hours)
Cost of ECV Procedure and Hospital Stay (Mother)
Time frame: ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)
Cost of ECV Procedure and Hospital Stay (Neonate)
Time frame: Birth to hospital discharge (up to 42 days)
Shoulder Dystocia
Time frame: Labor and Delivery (approximately 12 hours)
Rupture of Membranes
Time frame: Within 1 hour of ECV procedure
Emergency Cesarean Delivery
Time frame: During or within 1 hour of performing ECV procedure
Pelvic Hematoma
Time frame: During or within 1 hour of performing ECV procedure
Procedural Pain During Device Insertion
Time frame: Within 2 minutes after insertion of balloon device.
Number of Attempts
Time frame: Immediately after ECV procedure
Cost of Hospital Stay for ECV Procedure
Time frame: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)
Procedural Pain Prior to Device Insertion.
Time frame: Within 3 minutes prior to insertion of device.
Procedural Pain After Inflation of Device or Sham Inflation.
Time frame: Within 1 minute after device inflation or sham inflation.
Pain After External Cephalic Version Attempt.
Time frame: Within 2 minutes of ECV procedure completion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32332415External Cephalic Version: ACOG Practice Bulletin, Number 221. Obstet Gynecol. 2020 May;135(5):e203-e212. doi: 10.1097/AOG.0000000000003837.
- Results publication: PubMed 26868074Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j.ijgo.2015.09.019. Epub 2016 Jan 15.
- Results publication: PubMed 25828903Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3.
- Results publication: PubMed 18456227Kok M, Cnossen J, Gravendeel L, van der Post J, Opmeer B, Mol BW. Clinical factors to predict the outcome of external cephalic version: a metaanalysis. Am J Obstet Gynecol. 2008 Dec;199(6):630.e1-7; discussion e1-5. doi: 10.1016/j.ajog.2008.03.008. Epub 2008 May 23.
- Results publication: PubMed 18055730Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: 10.1097/01.AOG.0000295605.38175.7b.
- Individual participant dataSharing planned: No. IPD will not be shared outside of research team.
Related trials for Breech Presentation
RecruitingObservational study
Clinical Validation of an Artificial Intelligence System for De-termining Fetal Lie and Position in 3rd Trimester
Pregnancy, Fetal Presentation
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
RecruitingObservational study
Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation
Breech Presentation
RecruitingObservational study
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
Breech Presentation
Recruiting
An Informative Video Before Planned External Cephalic Version
Breech Presentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Hill, MD principal investigator
AdventHealth
Ariana Mora study director
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Pillow insertion in people with Breech Presentation and External Cephalic Version, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Having Successful Conversion to Cephalic Presentation (time frame: Immediately upon completion of the ECV procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538261, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.