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Planned Early Induction of Labor vs Expectant Management for PROM

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07802041
Lead Sponsor Pakistan Institute of Medical Sciences
Conditions
(from sponsor)
Premature Rupture of Membranes (PROM)
Related terms Chorioamnionitis, Premature Rupture of Fetal Membranes
Enrollment 734 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov