Elevation of the Fetal Buttocks Prior to External Cephalic Version
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breech Presentation
- Sponsor
- AdventHealth
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Number of Participants Having Successful Conversion to Cephalic Presentation
- Status
- Terminated
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Patient speaks English or Spanish as primary language.
- •Patient able to understand verbal and written consent
Exclusion Criteria
- •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/m
- •Uterine fibroids causing soft tissue dystocia.
- •Extended fetal neck.
- •Oligohydramnios (4-quadrant amniotic fluid index \</= 5cm).
- •Spontaneous rupture of membranes.
Outcomes
Primary Outcomes
Number of Participants Having Successful Conversion to Cephalic Presentation
Time Frame: Immediately upon completion of the ECV procedure
Successful conversion of breech fetus to cephalic presentation
Secondary Outcomes
- Cost of ECV Procedure and Hospital Stay (Neonate)(Birth to hospital discharge (up to 42 days))
- Shoulder Dystocia(Labor and Delivery (approximately 12 hours))
- Rupture of Membranes(Within 1 hour of ECV procedure)
- Emergency Cesarean Delivery(During or within 1 hour of performing ECV procedure)
- Pelvic Hematoma(During or within 1 hour of performing ECV procedure)
- 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))
- Procedural Pain During Device Insertion(Within 2 minutes after insertion of balloon device.)
- Number of Attempts(Immediately after ECV procedure)
- Cost of Hospital Stay for ECV Procedure(Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours))
- Procedural Pain Prior to Device Insertion.(Within 3 minutes prior to insertion of device.)
- Procedural Pain After Inflation of Device or Sham Inflation.(Within 1 minute after device inflation or sham inflation.)
- Pain After External Cephalic Version Attempt.(Within 2 minutes of ECV procedure completion.)