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Planned Early Induction of Labor vs Expectant Management for PROM
Sponsor: Pakistan Institute of Medical Sciences
Summary
The goal of this randomized controlled trial is to compare planned early induction of labor with expectant management in women with term premature rupture of membranes (PROM) at 37-42 weeks of gestation. The main questions it aims to answer are: Does planned early induction of labor reduce maternal and fetal complications compared with expectant management? Is there a difference in the frequency of cesarean section, chorioamnionitis, and fetal distress between the two management strategies? Researchers will compare active management (induction of labor within 24 hours) with expectant management (observation for 24 hours while awaiting spontaneous onset of labor). Participants will: Be women aged 18-45 years with singleton pregnancies and PROM at 37-42 weeks. Be randomly assigned to either active or expectant management. Receive routine monitoring and intravenous antibiotics until delivery. Be followed until delivery, with maternal and fetal outcomes recorded.
Official title: Planned Early Induction of Labor Versus Expectant Management for Premature Rupture of Membranes
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
734
Start Date
2026-05-01
Completion Date
2026-11-01
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
Induction of labor with PGE2
Induction of labor within 24 hours of diagnosis of term PROM, using prostaglandin E2 vaginal gel as per study protocol.
Expectant management
Observation for 24 hours while awaiting spontaneous onset of labor, with maternal and fetal monitoring.
Locations (1)
Pakistan institute of medical sciences Islamabad
Islamabad, Pakistan