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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07503184
Enrollment
60
Registered
2026-03-31
Start date
2025-07-15
Completion date
2026-01-14
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Rupture of membranes, Induction of Labor, Duration of Labor, 1st Stage of labor, 2nd Stage of Labor, Dexamethasone

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.

Interventions

DRUGDexamethasone

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

25 µg vaginal prostaglandin E1 will be used to induce labor

DRUGNormal Saline

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

Sponsors

Nishtar Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Induction-delivery timeFrom enrollment till fetus delivery, within 24-hoursTime in hours from PGE1 vaginal placement to delivery of the fetus

Countries

Pakistan

Contacts

STUDY_CHAIRSyeda A Professor, FCPS

Nishtar Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026