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

NCT07503184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-31

No results posted yet for this study

Summary

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.

Conditions

  • Rupture of Membranes Prior to Onset of Labor
  • Induction of Labor
  • Dexamethasone

Interventions

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

DRUG

Normal Saline

2 ml intravenous normal saline will be given as placebo, will be given one hour before initiation of labor induction

Sponsors & Collaborators

  • Nishtar Medical University

    lead OTHER

Principal Investigators

  • Syeda A Professor, FCPS · Nishtar Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-01-14
Completion
2026-01-14

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503184 on ClinicalTrials.gov