An interventional study of Fetal Pillow insertion in Breech Presentation and External Cephalic Version, sponsored by AdventHealth. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Non-inflation of the balloon device
Device: Fetal Pillow insertion
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
Number of Participants Having Successful Conversion to Cephalic Presentation
Successful conversion of breech fetus to cephalic presentation
Time frame: Immediately upon completion of the ECV procedure
Cesarean Delivery
Presence of cesarean delivery
Time frame: Immediately after ECV procedure or during subsequent labor and delivery
Fetal Presentation at Time of Delivery
Cephalic presentation of the fetus during participant delivery
Time frame: Labor and Delivery (approximately 12 hours)
Cost of ECV Procedure and Hospital Stay (Mother)
Cost of ECV procedure and hospital stay (mother)
Time frame: 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
Time frame: Birth to hospital discharge (up to 42 days)
Shoulder Dystocia
Presence of shoulder dystocia during delivery
Time frame: Labor and Delivery (approximately 12 hours)
Rupture of Membranes
Presence of rupture of membranes after ECV procedure
Time frame: Within 1 hour of ECV procedure
Emergency Cesarean Delivery
Need for emergency cesarean delivery during or after ECV procedure
Time frame: During or within 1 hour of performing ECV procedure
Pelvic Hematoma
Development of a pelvic hematoma within 1 hour of ECV procedure
Time frame: During or within 1 hour of performing ECV procedure
Procedural Pain During Device Insertion
Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 2 minutes after insertion of balloon device.
Number of Attempts
Number of attempted ECV procedures to convert fetus from breech to cephalic presentation
Time frame: Immediately after ECV procedure
Cost of Hospital Stay for ECV Procedure
Total cost of the hospital stay for the ECV procedure
Time frame: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)
Procedural Pain Prior to Device Insertion.
Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 3 minutes prior to insertion of device.
Procedural Pain After Inflation of Device or Sham Inflation.
Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 1 minute after device inflation or sham inflation.
Pain After External Cephalic Version Attempt.
Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 2 minutes of ECV procedure completion.
| Milestone | Control | Intervention |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
Successful conversion of breech fetus to cephalic presentation
| Participants | Control | Intervention |
|---|---|---|
| Number of Participants Having Successful Conversion to Cephalic Presentation | 3 | 2 |
Presence of cesarean delivery
| Participants | Control | Intervention |
|---|---|---|
| Cesarean Delivery | 0 | 0 |
Cephalic presentation of the fetus during participant delivery
| Participants | Control | Intervention |
|---|---|---|
| Fetal Presentation at Time of Delivery | 3 | 3 |
Cost of ECV procedure and hospital stay (mother)
No measurements were reported for this outcome.
Cost of neonate's hospitalization after delivery
No measurements were reported for this outcome.
Presence of shoulder dystocia during delivery
| Participants | Control | Intervention |
|---|---|---|
| Shoulder Dystocia | 0 | 0 |
Presence of rupture of membranes after ECV procedure
| Participants | Control | Intervention |
|---|---|---|
| Rupture of Membranes | 0 | 0 |
Need for emergency cesarean delivery during or after ECV procedure
| Participants | Control | Intervention |
|---|---|---|
| Emergency Cesarean Delivery | 0 | 0 |
Development of a pelvic hematoma within 1 hour of ECV procedure
| Participants | Control | Intervention |
|---|---|---|
| Pelvic Hematoma | 0 | 0 |
Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
| units on a scale | Control | Intervention |
|---|---|---|
| Procedural Pain During Device Insertion | 29 (0 to 69) | 59.6 (3 to 85) |
Number of attempted ECV procedures to convert fetus from breech to cephalic presentation
| Number of attempts | Control | Intervention |
|---|---|---|
| Number of Attempts | 2.3 ± 1.4 | 2.6 ± 1.5 |
Total cost of the hospital stay for the ECV procedure
No measurements were reported for this outcome.
Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
| units on a scale | Control | Intervention |
|---|---|---|
| Procedural Pain Prior to Device Insertion. | 4.8 (0 to 12) | 10.4 (0 to 30) |
Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
| units on a scale | Control | Intervention |
|---|---|---|
| Procedural Pain After Inflation of Device or Sham Inflation. | 22 (0 to 75) | 31 (4 to 60) |
Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
| units on a scale | Control | Intervention |
|---|---|---|
| Pain After External Cephalic Version Attempt. | 38.7 (10 to 60) | 29.2 (0 to 58) |
Collected over 1 hour after completion of ECV procedure until discharge after delivery (average of 3.5 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Intervention | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 30.5 ± 6.2 | 28.6 ± 3.9 | 29.5 ± 5.1 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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