Intravenous Dexamethasone for Inducing Labor in Women With Term Pregnancy and Pre-Labour Rupture of Membranes

March 25, 2026 updated by: Dr. Marwa Rahimi, Nishtar Medical University

Use of Intravenous Dexamethasone for Labor Induction in Term Pregnancies With Pre-labour Rupture of Membranes

This clinical trial aims to determine whether giving intravenous dexamethasone can shorten the time it takes for women to deliver after labor induction in term pregnancies with pre-labour rupture of membranes (PROM). PROM refers to the breaking of the water at least one hour before the start of labor contractions. When this occurs at term, labor is often induced to reduce risks to both mother and baby.

The main question this study seeks to answer is: Does intravenous dexamethasone reduce the time from the start of labor induction to delivery compared to a placebo?

Researchers hypothesize that women who receive dexamethasone will have a shorter induction-to-delivery time than those who receive a placebo.

To test this, 60 first-time pregnant women (primigravida), aged 18 to 45 years, with a single full-term pregnancy and PROM will be enrolled. Participants will be randomly assigned into two groups. One group will receive 8 mg intravenous dexamethasone, while the other group will receive a placebo (normal saline), both administered one hour before labor induction.

Labor will be induced using standard medications, including vaginal prostaglandin (misoprostol) followed by oxytocin infusion if needed. Progress of labor will be closely monitored using a partograph, and the duration of different stages of labor will be recorded by trained staff unaware of the treatment given.

All participants will be monitored during labor and for 24 hours after delivery to ensure safety. The results will help determine whether dexamethasone is an effective and safe option to improve labor outcomes in women with PROM at term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • Nishtar Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primigravida
  • Singleton fetus (on antenatal scan)
  • Full term - gestational age 37 - 41 weeks
  • Presenting with pre-labour rupture of membranes

Exclusion Criteria:

  • Chronic hypertension
  • Diabetes mellitus
  • Gestational diabetes
  • Antepartum hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Intravenous dexamethasone
Drug: Dexamethasone
8 mg (2 ml) intravenous dexamethasone sodium phosphate will be given one hour before initiation of labor induction
Drug: Prostaglandin E1
25 µg vaginal prostaglandin E1 will be used to induce labor
Other Names:
  • Cytotec
  • Misoprostol
Placebo Comparator: Normal Saline
Intravenous Normal Saline
Drug: Prostaglandin E1
25 µg vaginal prostaglandin E1 will be used to induce labor
Other Names:
  • Cytotec
  • Misoprostol
Drug: Normal Saline
2 ml intravenous normal saline will be given as placebo, will be given one hour before initiation of labor induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction-delivery time
Time Frame: From enrollment till fetus delivery, within 24-hours
Time in hours from PGE1 vaginal placement to delivery of the fetus
From enrollment till fetus delivery, within 24-hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nishtar Medical University

Investigators

  • Study Chair: Syeda A Professor, FCPS, Nishtar Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Actual)

January 14, 2026

Study Completion (Actual)

January 14, 2026

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1337-5682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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