Early V/S Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes (PROM)

A Comparative Study on Early Versus Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes at Term

To compare the effects of early V/s delayed induction of labour and its outcomes in patients presenting with PROM without labour.

Study Overview

• Status: Completed
• Conditions: Induction of Labor; Prelabor Rupture of Membranes; Labor (Obstetrics)--Complications
• Intervention / Treatment: Drug: 0.5mg PGE2 gel; Drug: 0.5mg PGE2 gel

Detailed Description

This is a comparative study where the patient who presented with PROM were assigned 2 groups of intervention . One had early induction of labour and other had induction of labour after 24 hours of observation. Both groups were compared for the average time of labour till delivery of the fetus and the frequency of spontaneous vaginal delivery was also calculated for each group.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Hameed Lateef Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. singleton pregnancy with cephalic presentation
2. gestational age between 37-41 weeks as calculated by last menstrual period date or early dating ultrasoumd
3. Spontaeous PROM as confirmed by history and sterile speculum examination
4. modified bishop score <6
5. no detectable uterine contractions on admission
6. clear liqour and duration of PROM <6 hours at admission

Exclusion Criteria:

1. meconium stained liqour
2. patients with features of chorioamnionitis (fever , tachycardia, abdominal tendernessor foul smeeling vaginal discharge
3. maternal medical diseaseincluding prompt delivery or C section like severe preeeclampsia, renal or cardiac disease
4. presence of contraindications to labour such as placenta previa , Vasa previa,previous uterine surgery (e.g myomectomy ) that increases the risk of uterine rupture , previous C section
5. history of antepartum hemorrhage
6. Moderate to severe IUGR as diagnosed on ultrasound and doppler studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: early induction of labour for PROM; The patients assigned with this arm when presented with PROM were inducted immidiately for labour and no observation was done for 24 hours for spontaneous induction of labour	Drug: 0.5mg PGE2 gel; In this interventional group patients presenting with PROM will be immediately induced by 0.5mg PGE2 gel. If bishop score will not improve after 6 hours, then application of PGE2 gel will be repeated (maximum 2 doses); Drug: 0.5mg PGE2 gel; The patients assigned with this intervention will be observed for 24 hours following which induction will be done using 0.5mg PGE2 gel in posterior fornix of vagina.
Active Comparator: Late induction of Labour in PROM; The patients assigned with this arm were observed for 24 hours for any spontanous induction of labour and then only proceeded with manual induction.	Drug: 0.5mg PGE2 gel; In this interventional group patients presenting with PROM will be immediately induced by 0.5mg PGE2 gel. If bishop score will not improve after 6 hours, then application of PGE2 gel will be repeated (maximum 2 doses); Drug: 0.5mg PGE2 gel; The patients assigned with this intervention will be observed for 24 hours following which induction will be done using 0.5mg PGE2 gel in posterior fornix of vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of labour	the duration of labour was assesed after each method of induction when patients presented with PROM	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Normal Vaginal Delivery	Frequency of having a vaginal delivery was calculated in each interventional group	24 hours

Collaborators and Investigators

• Sponsor: Laiba Qamar

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2025
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prelabor rupture of membranes; complicated labor; early Versus delayed labor induction
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: #PLROM225#

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participants have not given the cosent to share their personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No