Trial Outcomes & Findings for Cervical Foley Plus Vaginal Misoprostol for Labor Induction (NCT NCT01279343)

NCT ID: NCT01279343

Last Updated: 2019-05-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2019-05-03

Participant Flow

Participant milestones

Measure	Foley Bulb Plus Misoprostol In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol The participants in this arm received misoprostol 25 micrograms every 4 hours.
Overall Study STARTED	59	64
Overall Study COMPLETED	57	58
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Measure	Foley Bulb Plus Misoprostol In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol The participants in this arm received misoprostol 25 micrograms every 4 hours.
Overall Study Did not receive treatment	2	6

Baseline Characteristics

Cervical Foley Plus Vaginal Misoprostol for Labor Induction

Baseline characteristics by cohort

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.	Total n=117 Participants Total of all reporting groups
Age, Continuous	25.7 years STANDARD_DEVIATION 7.2 • n=5 Participants	24.2 years STANDARD_DEVIATION 5.5 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	61 Participants n=7 Participants	117 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	2 Participants n=7 Participants	2 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	34 Participants n=5 Participants	40 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	24 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	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants	61 participants n=7 Participants	117 participants n=5 Participants
Maternal weight	89.6 kg STANDARD_DEVIATION 20.3 • n=5 Participants	90.6 kg STANDARD_DEVIATION 24.9 • n=7 Participants	NA kg STANDARD_DEVIATION NA • n=5 Participants
Indication for labor inductions Postdates	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Indication for labor inductions Preeclampsia	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Indication for labor inductions Chronic Hypertension	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Indication for labor inductions Pregnancy induced hyptertension	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Indication for labor inductions Pregestational diabetes	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Indication for labor inductions Gestational diabetes	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Indication for labor inductions Oligohydramnios	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Indication for labor inductions Elective	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Indication for labor inductions Other	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Time From Start of Labor Induction to Vaginal Delivery	15.3 hour Standard Deviation 6.5	18.3 hour Standard Deviation 8.7

SECONDARY outcome

Timeframe: 72 hours

To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Successful Number of Vaginal and Cesarean Deliveries Vaginal delivery	41 Participants	45 Participants
Successful Number of Vaginal and Cesarean Deliveries Cesarean delivery	15 Participants	16 Participants

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Number of Participants Experiencing Tachysystole With Deceleration	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Number of Participants With Post-partum Hemorrhage	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Chorioamnionitis	5 Participants	7 Participants

SECONDARY outcome

Timeframe: 5 minutes

APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score:

Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Neonatal APGAR Scores 1 minute apgar scord	8 score on a scale Interval 2.0 to 9.0	8 score on a scale Interval 2.0 to 9.0
Neonatal APGAR Scores 5 minute apgar score	9 score on a scale Interval 1.0 to 9.0	9 score on a scale Interval 7.0 to 9.0

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
NICU Admission	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 72 hours

We will record the start time of induction until the patient's cervix is 10cm dilated

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Time to Complete Cervical Dilation	13.7 hour Standard Deviation 5.9	17.1 hour Standard Deviation 8.7

SECONDARY outcome

Timeframe: Delivery within 24 hours of induction

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Delivery Within 24 Hours	49 Participants	46 Participants

SECONDARY outcome

Timeframe: birth to 96 hours of age

Outcome measures

Measure	Foley Bulb Plus Misoprostol n=56 Participants In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants.	Misoprostol n=61 Participants The participants in this arm received misoprostol 25 micrograms every 4 hours.
Admission to NICU or Special Care Nursery	8 Participants	11 Participants

Adverse Events

Foley Bulb Plus Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Misoprostol

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

Jeanine Carbone MD

Washington University School of Medicine

Phone: 314-362-8523

Email: jfcarbone@hotmail.com

Results disclosure agreements

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