Elevation of the Fetal Buttocks Prior to External Cephalic Version

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.

Study Overview

• Status: Recruiting
• Conditions: Breech Presentation; External Cephalic Version
• Intervention / Treatment: Device: Fetal Pillow insertion

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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Hill, MD; Phone Number: 407-303-1444; Email: D.Hill.MD@AdventHealth.com
• Study Contact Backup: Name: Ariana Mora; Phone Number: 407-303-9415; Email: Ariana.Mora@AdventHealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Orlando
      • Contact: Ariana Mora; Phone Number: 407-303-9415; Email: Ariana.Mora@AdventHealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women delivering at AdventHealth Orlando campus.
2. Breech presenting part as diagnosed by bedside sonography.
3. No prior deliveries >/= 20 weeks gestational age.
4. Pregnancy is between 37-40 weeks gestational age.
5. Live fetus.
6. Patient is >/= age 18.
7. Patient speaks English or Spanish as primary language.
8. Patient able to understand verbal and written consent

Exclusion Criteria:

1. Non-breech presentation (cephalic, transverse, oblique).
2. More than 1 fetus.
3. Cervical dilation of >/= 1cm.
4. Prior uterine incision.
5. Congenital uterine anomaly.
6. Body mass index more than 40 kg/m2.
7. Uterine fibroids causing soft tissue dystocia.
8. Extended fetal neck.
9. Oligohydramnios (4-quadrant amniotic fluid index </= 5cm).
10. Spontaneous rupture of membranes.
11. Any contraindication to vaginal delivery.
12. Intrauterine growth restriction (estimated fetal weight </= 10%ile).
13. 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.
14. Fetal gastroschisis.
15. Fetal neural tube defect.
16. Severe-range preeclampsia.
17. Patient had regional anesthesia immediately prior to ECV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; Non-inflation of the balloon device	Device: Fetal Pillow insertion; Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Experimental: Intervention; Inflation of the balloon device	Device: Fetal Pillow insertion; Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful external cephalic version	Successful conversion of breech fetus to cephalic presentation	Immediately upon completion of the ECV procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean delivery	Presence of cesarean delivery	Immediately after ECV procedure or during subsequent labor and delivery
Fetal presentation at time of delivery	Presentation of the fetus during participant delivery	Labor and Delivery (approximately 12 hours)
Cost of ECV procedure and hospital stay (mother)	Total cost of hospital stay for mother	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	Birth to hospital discharge (up to 42 days)
Shoulder dystocia	Presence of shoulder dystocia during delivery	Labor and Delivery (approximately 12 hours)
Rupture of membranes	Presence of rupture of membranes after ECV procedure	Within 1 hour of ECV procedure
Emergency cesarean delivery	Need for emergency cesarean delivery during or after ECV procedure	During or within 1 hour of performing ECV procedure
Pelvic hematoma	Development of a pelvic hematoma within 1 hour of ECV procedure	During or within 1 hour of performing ECV procedure
Procedural pain	Visual analogue pain score prior to during and after ECV procedure (100mm visual analogue scale where 0 =no pain and 10=extreme pain).	Immediately before, during, and within 2 minutes after completing the ECV procedure
Number of attempts	Number of attempted ECV procedures to convert fetus from breech to cephalic presentation	During and immediately after ECV procedure
Cost of hospital stay for ECV procedure	Total cost of the hospital stay for the ECV procedure	Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: David A Hill, MD, AdventHealth; Study Director: Ariana Mora, AdventHealth

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Breech; Version
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Breech Presentation
• Other Study ID Numbers: 1379199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared outside of research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No