N/A
N=123
Cervical Foley Plus Vaginal Misoprostol for Labor Induction
Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT01279343 ↗Enrolled (actual)
123
Serious AEs
—
Results posted
May 2019
Primary outcome: Primary: Time From Start of Labor Induction to Vaginal Delivery — 15.3; 18.3 hour — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foley bulb (Device)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Labor Induction to Vaginal Delivery |
15.3; 18.3 | 0.03 sig |
| SECONDARY Successful Number of Vaginal and Cesarean Deliveries |
41; 45; 15; 16 | 0.96 |
| SECONDARY Number of Participants Experiencing Tachysystole With Deceleration |
10; 12 | — |
| SECONDARY Number of Participants With Post-partum Hemorrhage |
2; 5 | — |
| SECONDARY Chorioamnionitis |
5; 7 | — |
| SECONDARY Neonatal APGAR Scores |
8; 8; 9; 9 | — |
| SECONDARY NICU Admission |
0; 2 | — |
| SECONDARY Time to Complete Cervical Dilation |
13.7; 17.1 | — |
| SECONDARY Delivery Within 24 Hours |
49; 46 | — |
| SECONDARY Admission to NICU or Special Care Nursery |
8; 11 | — |
Summary
The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.
Eligibility Criteria
Inclusion Criteria
- singleton pregnancy
- vertex presentation
- unfavorable cervix(Bishop's score less than or equal to 6)
- greater than 24 weeks gestation
Exclusion Criteria
- fetal malpresentation
- multifetal gestation
- spontaneous labor
- more than 5 uterine contractions in 10 minutes
- contraindication to prostaglandins
- non-reassuring fetal heart rate tracing
- intrauterine growth restriction
- anomalous fetus
- fetal demise
- previous cesarean delivery or other significant uterine surgery
Data sourced from ClinicalTrials.gov (NCT01279343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.