An interventional study of Induction of labor with PGE2 and Expectant management in Premature Rupture of Membranes (PROM), sponsored by Pakistan Institute of Medical Sciences. Enrolling by invitation at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Pakistan Institute of Medical Sciences · Not applicable, Interventional, and Other
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.
This randomized controlled trial will compare planned early induction of labor (active management) with expectant management in women with term premature rupture of membranes (PROM).
PROM is defined as rupture of the fetal membranes before the onset of labor. At term, the optimal timing of delivery remains an important clinical consideration because prolonged rupture of membranes may increase the risk of maternal and neonatal infection, while early delivery may increase interventions such as induction of labor and cesarean section.
The study will be conducted in the Department of Obstetrics and Gynaecology, PIMS Hospital, Islamabad, over a period of six months after approval of the synopsis. A total of 734 women will be enrolled using consecutive sampling and randomly allocated into two equal groups of 367 participants each.
Group A - Active Management:
Labor will be induced within 24 hours of diagnosis of PROM. Prostaglandin E2 vaginal gel (1 mg) will be used for cervical ripening/induction, with repeat doses at 6-hour intervals when required, up to a maximum of three doses.
Group B - Expectant Management:
Participants will undergo observation for 24 hours following diagnosis of PROM while awaiting spontaneous onset of labor. An endocervical swab will be collected for microscopy, culture, and sensitivity. Participants will be monitored for signs of infection and fetal compromise.
Both groups will receive intravenous antibiotics according to the study protocol (ceftriaxone 1 g every 24 hours and metronidazole 500 mg every 8 hours until delivery) and will be followed until delivery.
The study will compare maternal and fetal outcomes between the two groups, particularly:
Cesarean section Chorioamnionitis Fetal distress Baseline demographic and clinical characteristics, including age, gestational age, parity, BMI, socioeconomic status, educational level, and residential status, will also be recorded.
The purpose of the study is to determine whether planned early induction of labor or expectant management is associated with better maternal and fetal outcomes in women with term PROM.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 734 is above the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Pakistan Institute of Medical Sciences is the lead sponsor of 55 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Induction of labor within 24 hours of diagnosis of term premature rupture of membranes.
Procedure: Induction of labor with PGE2
Observation for 24 hours following diagnosis of term premature rupture of membranes while awaiting spontaneous onset of labor.
Behavioral: Expectant management
Induction of labor within 24 hours of diagnosis of term PROM, using prostaglandin E2 vaginal gel as per study protocol.
Observation for 24 hours while awaiting spontaneous onset of labor, with maternal and fetal monitoring.
Cesearan section rate
Proportion of participants who undergo cesarean delivery in the active management group compared with the expectant management group.
Time frame: From randomization until delivery
Chorioamnionitis
Proportion of participants developing clinical chorioamnionitis during labor or before delivery.
Time frame: From randomization until delivery.
Fetal distress
Proportion of participants developing fetal distress during labor requiring intervention.
Time frame: From randomization until delivery.
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Of 23 interventional studies with no phase under Fetal Membranes, Premature Rupture, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 62. This study's planned 6 months is below that.
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Pakistan Institute of Medical Sciences