Elevation of the Fetal Buttocks Prior to External Cephalic Version

AdventHealth

Status: Terminated

Conditions: External Cephalic Version; Breech Presentation

Treatments: Device: Fetal Pillow insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT04538261

1379199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Control

Sham Comparator group

Description:

Non-inflation of the balloon device

Treatment:

Device: Fetal Pillow insertion

Intervention

Experimental group

Description:

Inflation of the balloon device

Treatment:

Device: Fetal Pillow insertion