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=99 Participants
|
24.2 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=99 Participants
|
61 participants
n=107 Participants
|
117 participants
n=206 Participants
|
|
Maternal weight
|
89.6 kg
STANDARD_DEVIATION 20.3 • n=99 Participants
|
90.6 kg
STANDARD_DEVIATION 24.9 • n=107 Participants
|
NA kg
STANDARD_DEVIATION NA • n=206 Participants
|
|
Indication for labor inductions
Postdates
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Indication for labor inductions
Preeclampsia
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Indication for labor inductions
Chronic Hypertension
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Indication for labor inductions
Pregnancy induced hyptertension
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Indication for labor inductions
Pregestational diabetes
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Indication for labor inductions
Gestational diabetes
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Indication for labor inductions
Oligohydramnios
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Indication for labor inductions
Elective
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Indication for labor inductions
Other
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hoursOutcome 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 hoursTo 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 hoursOutcome 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 hoursOutcome 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 hoursOutcome 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 minutesAPGAR 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 hoursOutcome 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 hoursWe 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 inductionOutcome 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 ageOutcome 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: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place