Phase 4
N=108
Pitocin or Oral Misoprostol for PROM IOL
PROM
Bottom Line
View on ClinicalTrials.gov: NCT04028765 ↗Enrolled (actual)
108
Serious AEs
0.5%
Results posted
Apr 2024
Primary outcome: Primary: Time From Induction of Labor (IOL) to Delivery — 18.1; 14.9 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Misoprostol (Drug); Oxytocin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Induction of Labor (IOL) to Delivery |
18.1; 14.9 | — |
| SECONDARY Infection |
8; 6 | — |
| SECONDARY Time From Premature Rupture of Membranes (PROM) to Delivery |
25.8; 22.1 | — |
| SECONDARY Time From IOL to Vaginal Delivery |
17.9; 12.9 | — |
| SECONDARY Time From PROM to Vaginal Delivery |
24.9; 21.6 | — |
| SECONDARY Cesarean Delivery |
13; 14 | — |
| SECONDARY Maternal Morbidity |
8; 9 | — |
| SECONDARY Neonatal Morbidity |
1; 2 | — |
Summary
Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.
Eligibility Criteria
Inclusion Criteria
- English Speaking
- PROM /= 36 weeks gestation
- Agreeable to induction of labor
- Nulliparous
- Singleton pregnancy
- Vertex presentation
- Cervical dilation </=2 cm AND Bishop score < 8
Exclusion Criteria
- Prior cesarean section
- Other contraindication to vaginal delivery
- Intrauterine Fetal Demise
- Major Congenital Anomaly
- Intraamniotic infection diagnosed at time of admission
- 36 weeks - 36 weeks and 6 days with unknown Group B Strep (GBS) status
Data sourced from ClinicalTrials.gov (NCT04028765). 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.