Elevation of the Fetal Buttocks Prior to External Cephalic Version

NCT04538261 | Terminated Results DMC FDA Device

• 1 other identifier: 1379199
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breech Presentation; External Cephalic Version

Keywords

Breech; Version

Outcome Measures

Primary Outcomes (1)

• Number of Participants Having Successful Conversion to Cephalic Presentation

  Successful conversion of breech fetus to cephalic presentation

  Immediately upon completion of the ECV procedure

Secondary Outcomes (14)

• Cesarean Delivery

  Immediately after ECV procedure or during subsequent labor and delivery

• Fetal Presentation at Time of Delivery

  Labor and Delivery (approximately 12 hours)

• Cost of ECV Procedure and Hospital Stay (Mother)

  ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)

• Cost of ECV Procedure and Hospital Stay (Neonate)

  Birth to hospital discharge (up to 42 days)

• Shoulder Dystocia

  Labor and Delivery (approximately 12 hours)

Study Arms (2)

Control

SHAM COMPARATOR

Non-inflation of the balloon device

Device: Fetal Pillow insertion

Intervention

EXPERIMENTAL

Inflation of the balloon device

Device: Fetal Pillow insertion

Interventions

Fetal Pillow insertion DEVICE

Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Related Publications (5)

• External Cephalic Version: ACOG Practice Bulletin, Number 221. Obstet Gynecol. 2020 May;135(5):e203-e212. doi: 10.1097/AOG.0000000000003837.

  PMID: 32332415 BACKGROUND

• Seal 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.

  PMID: 26868074 RESULT

• Hofmeyr 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.

  PMID: 25828903 RESULT

• Kok 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.

  PMID: 18456227 RESULT

• Weiniger 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.

  PMID: 18055730 RESULT

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: D. Ashley Hill, MD
• Organization: AdventHealth Orlando

Ashley.Hill.MD@AdventHealth.com

407-303-1444

Study Officials

• David A Hill, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

• Ariana Mora

  AdventHealth

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators and participants will not know whether participants have undergone inflation of the balloon device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial using control and interventional arms.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 4, 2020
• Study Start: November 1, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)