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Planned Early Induction of Labor vs Expectant Management for PROM

NCT07802041 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 734

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Premature Rupture of Membranes (PROM)

Interventions

PROCEDURE

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.

BEHAVIORAL

Expectant management

Observation for 24 hours while awaiting spontaneous onset of labor, with maternal and fetal monitoring.

Sponsors & Collaborators

  • Pakistan Institute of Medical Sciences

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802041 on ClinicalTrials.gov