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

NCT07261332 | Completed DMC

• 1 other identifier: #PLROM225#
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor (Obstetrics)--Complications; Induction of Labor; Prelabor Rupture of Membranes

Keywords

prelabor rupture of membranes; complicated labor; early Versus delayed labor induction

Outcome Measures

Primary Outcomes (1)

• Duration of labour

  the duration of labour was assesed after each method of induction when patients presented with PROM

  24 hours

Secondary Outcomes (1)

• Frequency of Normal Vaginal Delivery

  24 hours

Study Arms (2)

early induction of labour for PROM

EXPERIMENTAL

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

Late induction of Labour in PROM

ACTIVE COMPARATOR

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

Interventions

0.5mg PGE2 gel DRUG

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)

early induction of labour for PROM

Eligibility Criteria

• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• meconium stained liqour
• patients with features of chorioamnionitis (fever , tachycardia, abdominal tendernessor foul smeeling vaginal discharge
• maternal medical diseaseincluding prompt delivery or C section like severe preeeclampsia, renal or cardiac disease
• 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
• history of antepartum hemorrhage
• Moderate to severe IUGR as diagnosed on ultrasound and doppler studies

Sponsors & Collaborators

• Laiba Qamar: lead

Study Sites (1)

Hameed Lateef Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Supervisor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: May 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)