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

NCT07503184 — Phase 4, Completed, 60 participants, Nishtar Medical University

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

Registry	NCT07503184
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Actual)
Sponsor	Nishtar Medical University (Other)
Conditions	Rupture of Membranes Prior to Onset of Labor, Induction of Labor, Dexamethasone
Interventions	Dexamethasone, Prostaglandin E1, Normal Saline (Drug)
Dates	start 2025-07-15, primary completion 2026-01-14, completion 2026-01-14, first posted 2026-03-31, last updated 2026-03-31
Locations	1 site in Pakistan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dexamethasone	Experimental	Drug: Dexamethasone; Drug: Prostaglandin E1	Intravenous dexamethasone
Normal Saline	Placebo comparator	Drug: Prostaglandin E1; Drug: Normal Saline	Intravenous Normal Saline

Dexamethasone (Drug): 8 mg (2 ml) intravenous dexamethasone sodium phosphate will be given one hour before initiation of labor induction
Prostaglandin E1 (Drug), also known as Misoprostol, Cytotec: 25 µg vaginal prostaglandin E1 will be used to induce labor
Normal Saline (Drug): 2 ml intravenous normal saline will be given as placebo, will be given one hour before initiation of labor induction

+Outcome measures

Primary outcomes

Induction-delivery time [From enrollment till fetus delivery, within 24-hours]: Time in hours from PGE1 vaginal placement to delivery of the fetus

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Nishtar Medical University	Multan, Punjab Province	Pakistan

+Investigators

Syeda A Professor, FCPS, Study chair, Nishtar Medical University