N/A
N=50
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT01139801 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Rate of Induction To Delivery — 732.19; 944.35 minutes — p=0.037
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxytocin (Drug); Misoprostol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aultman Health Foundation
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Induction To Delivery |
732.19; 944.35 | 0.037 sig |
| SECONDARY Delivery Route |
16; 17; 9; 8 | — |
Summary
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
Eligibility Criteria
Inclusion Criteria
- Participant or surrogate is capable of giving informed consent
- Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
- Participant is undergoing an indicated induction of labor
- Participant is found to have cervical Bishop score ≤5 on initial cervical exam
- Participant has no medical or obstetrical contraindications to induction of labor
Exclusion Criteria
- Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
- Manufacturer's contraindications to misoprostol or oxytocin
Data sourced from ClinicalTrials.gov (NCT01139801). 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.