Trial Outcomes & Findings for Elevation of the Fetal Buttocks Prior to External Cephalic Version (NCT NCT04538261)

NCT ID: NCT04538261

Last Updated: 2025-06-03

Results Overview

Successful conversion of breech fetus to cephalic presentation

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Immediately upon completion of the ECV procedure
• Results posted on: 2025-06-03

Participant Flow

Participant milestones

Measure	Control Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Elevation of the Fetal Buttocks Prior to External Cephalic Version

Baseline characteristics by cohort

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Total n=11 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 6.2 • n=5 Participants	28.6 years STANDARD_DEVIATION 3.9 • n=7 Participants	29.5 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately upon completion of the ECV procedure

Successful conversion of breech fetus to cephalic presentation

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon 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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Immediately after ECV procedure or during subsequent labor and delivery

Presence of cesarean delivery

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Cesarean Delivery	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Labor and Delivery (approximately 12 hours)

Cephalic presentation of the fetus during participant delivery

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Fetal Presentation at Time of Delivery	3 Participants	3 Participants

SECONDARY outcome

Timeframe: ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)

Population: Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.

Cost of ECV procedure and hospital stay (mother)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Birth to hospital discharge (up to 42 days)

Population: Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.

Cost of neonate's hospitalization after delivery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Labor and Delivery (approximately 12 hours)

Presence of shoulder dystocia during delivery

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Shoulder Dystocia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 1 hour of ECV procedure

Presence of rupture of membranes after ECV procedure

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Rupture of Membranes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During or within 1 hour of performing ECV procedure

Need for emergency cesarean delivery during or after ECV procedure

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Emergency Cesarean Delivery	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During or within 1 hour of performing ECV procedure

Development of a pelvic hematoma within 1 hour of ECV procedure

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Pelvic Hematoma	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 2 minutes after insertion of balloon device.

Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Procedural Pain During Device Insertion	29 units on a scale Interval 0.0 to 69.0	59.6 units on a scale Interval 3.0 to 85.0

SECONDARY outcome

Timeframe: Immediately after ECV procedure

Number of attempted ECV procedures to convert fetus from breech to cephalic presentation

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Number of Attempts	2.3 Number of attempts Standard Deviation 1.4	2.6 Number of attempts Standard Deviation 1.5

SECONDARY outcome

Timeframe: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)

Population: Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.

Total cost of the hospital stay for the ECV procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 3 minutes prior to insertion of device.

Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Procedural Pain Prior to Device Insertion.	4.8 units on a scale Interval 0.0 to 12.0	10.4 units on a scale Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: Within 1 minute after device inflation 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).

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Procedural Pain After Inflation of Device or Sham Inflation.	22 units on a scale Interval 0.0 to 75.0	31 units on a scale Interval 4.0 to 60.0

SECONDARY outcome

Timeframe: Within 2 minutes of ECV procedure completion.

Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).

Outcome measures

Measure	Control n=6 Participants Non-inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure	Intervention n=5 Participants Inflation of the balloon device Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Pain After External Cephalic Version Attempt.	38.7 units on a scale Interval 10.0 to 60.0	29.2 units on a scale Interval 0.0 to 58.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

D. Ashley Hill, MD

AdventHealth Orlando

Phone: 407-303-1444

Email: Ashley.Hill.MD@AdventHealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place