Trial Outcomes & Findings for Foley Catheter Versus Cervidil for Induction of Labor at Term (NCT NCT01402050)

NCT ID: NCT01402050

Last Updated: 2020-03-02

Results Overview

The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction. There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours. Key word: INDUCTION OF LABOR

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 376 participants
• Primary outcome timeframe: Hours
• Results posted on: 2020-03-02

Participant Flow

Participant milestones

Measure	FOLEY BALLOON Comparing Foley balloon to Cervidil for decreased time from the start of the induction process to delivery is the aim of this RCT. Subjects randomized into the Foley Balloon Arm received a Foley Balloon past the cervical os filled with 30 cc of sterile water, and catheter taped to inside of maternal thigh. Catheter was removed for any of the 5 reasons: expulsion, nonreasurring fetal heart rate tracing mandating placement of internal monitors, tachysystole, spontaneous membrane rupture, or 12 hours elapsed since placement. Key words: FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL CERVIDIL (Dinoprostone) Arm: Subjects randomized to this arm received dinoprostone controlled release vaginal insert (standard dosing Cervidil, 0.3mg/hour of dinoprostone over 12 hours). The vaginal insert was placed in the posterior fornix and was removed for any of the 5 reasons stated for the Foley catheter Arm description. Fetal heart rate and uterine contractions were continuously monitored per standard. Time of placement was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction. Key word: INDUCTION OF LABOR
Overall Study STARTED	185	191
Overall Study COMPLETED	185	191
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Foley Catheter Versus Cervidil for Induction of Labor at Term

Baseline characteristics by cohort

Measure	FOLEY BALLOON n=185 Participants Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL n=191 Participants CERVIDIL (Dinoprostone): INDUCTION OF LABOR	Total n=376 Participants Total of all reporting groups
Age, Continuous	28.0 years STANDARD_DEVIATION 6.4 • n=5 Participants	26.9 years STANDARD_DEVIATION 5.9 • n=7 Participants	27.5 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	185 Participants n=5 Participants	191 Participants n=7 Participants	376 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	87 Participants n=5 Participants	81 Participants n=7 Participants	168 Participants n=5 Participants
Race/Ethnicity, Customized Black	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	44 Participants n=5 Participants	60 Participants n=7 Participants	104 Participants n=5 Participants
Race/Ethnicity, Customized Other	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	185 participants n=5 Participants	191 participants n=7 Participants	376 participants n=5 Participants

PRIMARY outcome

Timeframe: Hours

The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction.

There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours.

Key word: INDUCTION OF LABOR

Outcome measures

Measure	FOLEY BALLOON n=185 Participants Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL n=191 Participants CERVIDIL (Dinoprostone): INDUCTION OF LABOR
Time Of Start Of Induction Of Labor To Delivery	21.6 hours Interval 15.7 to 35.1	26.6 hours Interval 19.0 to 37.8

Adverse Events

FOLEY BALLOON

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CERVIDIL

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FOLEY BALLOON n=185 participants at risk Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL n=191 participants at risk CERVIDIL (Dinoprostone): INDUCTION OF LABOR
Gastrointestinal disorders Neonatal event	0.00% 0/185	1.0% 2/191 • Number of events 2

Additional Information

Ana Braescu

Phoenix Perinatal Associates - Mednax

Phone: 602-614-0488

Email: ana_braescu@mednax.com

Results disclosure agreements

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