Skip to main content
OpenTrials
Completed

NCT Number: NCT07261332

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prelabor Rupture of Membranes Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Induction of Labor Labor (Obstetrics)--Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hameed Lateef Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Duration of labour

    Time frame: 24 hours

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

Secondary outcomes

  1. Frequency of Normal Vaginal Delivery

    Time frame: 24 hours

    Frequency of having a vaginal delivery was calculated in each interventional group

Sponsors and collaborators

Lead sponsor

Laiba Qamar

Other

Registry information

Official study title

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

Acronym: PROM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.