Phase 3
Completed N=200
Prostin and Propess in Induction of Labor
Source: ClinicalTrials.gov NCT01635439 ↗Enrolled (actual)
200
Serious AEs
1.5%
Results posted
Oct 2012
Primary outcomePrimary: Induction to Delivery Interval — 22.3; 21.2 hours
Summary
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction to Delivery Interval |
22.3; 21.2 | — |
| SECONDARY Induction to Onset of Labor Interval |
18.8; 17.7 | — |
| SECONDARY Uterine Hyper-stimulation Rate |
1; 1 | — |
| SECONDARY Need for Syntocinon Augmentation |
5; 10 | — |
| SECONDARY Normal Vaginal Delivery Rate |
79; 85 | — |
Eligibility Criteria
Inclusion Criteria
- Gestational age 37 weeks or more
- Singleton pregnancy
- Cephalic presentation.
Exclusion Criteria
- Previous cesarean section
- Any contraindication for vaginal delivery
- Suspected Cephalo-Pelvic Disproportion
- Unexplained antepartum Hemorrhage
Data sourced from ClinicalTrials.gov (NCT01635439). 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. Informational only — not medical advice.