Elevation of the Fetal Buttocks Prior to External Cephalic Version

Not Applicable

Terminated

• Conditions: Breech Presentation; External Cephalic Version
• Interventions: Device: Fetal Pillow insertion

• Registration Number: NCT04538261
• Lead Sponsor: AdventHealth

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.

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 Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-04
• Study Start: 2020-11-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Fetal Pillow insertion	Inflation of the balloon device
Control	Fetal Pillow insertion	Non-inflation of the balloon device

Primary Outcome Measures

Name	Time	Method
Successful external cephalic version	Immediately upon completion of the ECV procedure	Successful conversion of breech fetus to cephalic presentation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States