Phase 3
N=1,308
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
Cervical Ripening · Labor, Induced
Bottom Line
View on ClinicalTrials.gov: NCT00308711 ↗Enrolled (actual)
1,308
Serious AEs
27.3%
Results posted
Feb 2010
Primary outcome: Primary: Minutes From Drug Insertion to Vaginal Delivery — 1595.5; 2127; 1649.5 minutes — p=0.974
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Misoprostol vaginal insert 100 mcg (Drug); Misoprostol vaginal insert 50 mcg (Drug); Dinoprostone vaginal insert (Cervidil) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minutes From Drug Insertion to Vaginal Delivery |
1595.5; 2127; 1649.5 | 0.974 |
| PRIMARY Percentage of Participants With a Cesarean Section Delivery |
28; 28; 26 | 0.64 |
| SECONDARY Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events |
65; 64; 65; 29; 26; 27 | — |
| SECONDARY Percentage of Participants With Pre-Delivery Oxytocin Use |
68.5; 80.8; 69.0 | — |
| SECONDARY Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert |
59; 50; 60 | — |
| SECONDARY Minutes to Onset of Active Labor |
1032.5; 1343.7; 1005.2 | — |
| SECONDARY Minutes to Rupture of Membranes (ROM) |
1285.0; 1364.0; 1123 | — |
| SECONDARY Duration of Stay in Minutes in Labor and Delivery Suite |
1683.6; 2010; 1729 | — |
| SECONDARY Days in Hospital for Mother and Neonate |
4.5; 4.7; 4.5; 3.6; 3.5; 3.6 | — |
Summary
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Eligibility Criteria
Inclusion Criteria
- Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor
Exclusion Criteria
- No uterine scar (no previous delivery by cesarean section)
- No multiple gestation
- No condition that disallows use of prostaglandins for induction of labor
- No more than 3 previous vaginal births beyond 24 weeks gestation
Data sourced from ClinicalTrials.gov (NCT00308711). 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.