NCT07503184

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

DexamethasoneRupture of Membranes Prior to Onset of LaborInduction of Labor

Keywords

Rupture of membranesInduction of LaborDuration of Labor1st Stage of labor2nd Stage of LaborDexamethasone

Outcome Measures

Primary Outcomes (1)

  • Induction-delivery time

    Time in hours from PGE1 vaginal placement to delivery of the fetus

    From enrollment till fetus delivery, within 24-hours

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Intravenous dexamethasone

Drug: DexamethasoneDrug: Prostaglandin E1

Normal Saline

PLACEBO COMPARATOR

Intravenous Normal Saline

Drug: Prostaglandin E1Drug: Normal Saline

Interventions

DexamethasoneDRUG

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

Dexamethasone
Prostaglandin E1DRUG

25 µg vaginal prostaglandin E1 will be used to induce labor

Also known as: Misoprostol, Cytotec
DexamethasoneNormal Saline
Normal SalineDRUG

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

Normal Saline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Medical University

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

DexamethasoneAlprostadilMisoprostolSaline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedProstaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological FactorsProstaglandins E, SyntheticProstaglandins, SyntheticCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Syeda A Professor, FCPS

    Nishtar Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 31, 2026

Study Start

July 15, 2025

Primary Completion

January 14, 2026

Study Completion

January 14, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)