Elevation of the Fetal Buttocks Prior to External Cephalic Version

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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

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Breech Presentation External Cephalic Version

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial using control and interventional arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Investigators and participants will not know whether participants have undergone inflation of the balloon device.

Study Groups

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Control

Non-inflation of the balloon device

Group Type SHAM_COMPARATOR

Fetal Pillow insertion

Intervention Type DEVICE

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

Intervention

Inflation of the balloon device

Group Type EXPERIMENTAL

Fetal Pillow insertion

Intervention Type DEVICE

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

Interventions

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Fetal Pillow insertion

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes