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Completed

NCT Number: NCT07503184

Intravenous Dexamethasone for Inducing Labor in Women With Term Pregnancy and 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nishtar Medical University

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dexamethasone

Drug

8 mg (2 ml) intravenous dexamethasone sodium phosphate will be given one hour before initiation of labor induction

Prostaglandin E1

Drug

25 µg vaginal prostaglandin E1 will be used to induce labor

Other names: Misoprostol, Cytotec

normal saline

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

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.

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