Status:
COMPLETED
Pitocin or Oral Misoprostol for PROM IOL
Lead Sponsor:
University of Pennsylvania
Conditions:
PROM
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 a...
Detailed Description
Premature rupture of membranes (PROM) occurs in approximately 8% of pregnancies at term.1 Although onset of spontaneous labor is often prompt after membrane rupture, a delay from PROM to labor is asso...
Eligibility Criteria
Inclusion
- English Speaking
- PROM \</= 24 hours with no evidence of labor
- \>/= 36 weeks gestation
- Agreeable to induction of labor
- Nulliparous
- Singleton pregnancy
- Vertex presentation
- Cervical dilation \</=2 cm AND Bishop score \< 8
Exclusion
- 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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04028765
Start Date
August 12 2019
End Date
January 8 2023
Last Update
April 30 2024
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104