N/A
N=130
A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor
Induction of Labor in Multiparous Women
Bottom Line
View on ClinicalTrials.gov: NCT01634854 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Time From Induction to Vaginal Delivery — 800; 693 minutes — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vaginal Misoprostol (Drug); Intravenous Oxytocin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Induction to Vaginal Delivery |
800; 693 | 0.11 |
| SECONDARY Neonatal APGAR Scores |
8; 8; 9; 9 | — |
| SECONDARY Neonatal Weight at Delivery |
3500; 3415 | — |
| SECONDARY Maternal Delivery Outcomes |
56; 48; 2; 3; 2; 0 | — |
| SECONDARY Maternal Satisfaction With Labor |
— | — |
| SECONDARY Number of Participants With Excessive Uterine Activity Necessitating Treatment |
9; 4 | — |
| SECONDARY NICU Admission and APGAR Less Than 7 at 5 Minutes |
8; 4; 0; 0 | — |
Summary
This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.
Eligibility Criteria
Inclusion Criteria
- Clinical candidate for labor induction utilizing either misoprostol or oxytocin
- Greater than or equal to 18 years of age
- Multiparous
- Singleton gestation;
- Greater than 37 weeks gestation;
- Cephalic presentation
Exclusion Criteria
- Any clinical contraindication to misoprostol as induction drug
- Age less than 18 years
- Contraindication to vaginal birth
- Nonreassuring fetal heart rate tracing
- Prior uterine surgery
- Active labor
- Active maternal bleeding
- Chorioamnionitis (infection)
Data sourced from ClinicalTrials.gov (NCT01634854). 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.