Rupture of Membranes Prior to Onset of LaborPhase 4NCT07503184
Intravenous Dexamethasone for Inducing Labor in Women With Term Pregnancy and Pre-Labour Rupture of Membranes
A Phase 4 study testing Dexamethasone, Prostaglandin E1 and Normal Saline in people with Rupture of Membranes Prior to Onset of Labor and Induction of Labor, run by Nishtar Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Rupture of Membranes Prior to Onset of Labor, Induction of Labor, Dexamethasone
- What is being tested?
- Dexamethasone, Prostaglandin E1 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2025to 14 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravida
- Singleton fetus (on antenatal scan)
- Full term - gestational age 37 - 41 weeks
- Presenting with pre-labour rupture of membranes
Who cannot join
- Chronic hypertension
- Diabetes mellitus
- Gestational diabetes
- Antepartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Intravenous Dexamethasone for Labor Induction in Term Pregnancies With 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?
Read more
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.
- Being tested
- Dexamethasone, Prostaglandin E1, Normal Saline
- Keywords
- Rupture of membranes, Induction of Labor, Duration of Labor, 1st Stage of labor, 2nd Stage of Labor, Dexamethasone
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
8 mg (2 ml) intravenous dexamethasone sodium phosphate will be given one hour before initiation of labor induction
Prostaglandin E1Drug
Also called Misoprostol, Cytotec
25 µg vaginal prostaglandin E1 will be used to induce labor
Normal SalineDrug
2 ml intravenous normal saline will be given as placebo, will be given one hour before initiation of labor induction
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Intravenous dexamethasone Receives: Drug: Dexamethasone; Drug: Prostaglandin E1 |
| Normal Saline | Placebo comparator | Intravenous Normal Saline Receives: Drug: Prostaglandin E1; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction-delivery time
Time in hours from PGE1 vaginal placement to delivery of the fetus
Measured: From enrollment till fetus delivery, within 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start15 Jul 2025
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Membranes Prior to Onset of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marwa Rahimi, Nishtar Medical University
- Investigators
- Syeda A Professor, FCPS, Study chair, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503184
- Sponsor's protocol ID
- U1111-1337-5682
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intravenous Dexamethasone for Labor Induction in Term Pregnancies With Pre-labour Rupture of Membranes
- ClinicalTrials.gov ID
- NCT07503184
- Acronym / sponsor ID
- U1111-1337-5682
- Keywords
- Rupture of membranes, Induction of Labor, Duration of Labor, 1st Stage of labor, 2nd Stage of Labor, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone, Drug: Prostaglandin E1Intravenous dexamethasone |
| Normal Saline | Placebo comparator | Drug: Prostaglandin E1, Drug: Normal SalineIntravenous Normal Saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primigravida
- Singleton fetus (on antenatal scan)
- Full term - gestational age 37 - 41 weeks
- Presenting with pre-labour rupture of membranes
Key exclusion criteria (4 listed)
- Chronic hypertension
- Diabetes mellitus
- Gestational diabetes
- Antepartum hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone8 mg (2 ml) intravenous dexamethasone sodium phosphate will be given one hour before initiation of labor induction | Drug | Dexamethasone |
| Prostaglandin E1Also: Misoprostol, Cytotec25 µg vaginal prostaglandin E1 will be used to induce labor | Drug | Dexamethasone, Normal Saline |
| Normal Saline2 ml intravenous normal saline will be given as placebo, will be given one hour before initiation of labor induction | Drug | Normal Saline |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syeda A Professor, FCPS study chair
Nishtar Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Prostaglandin E1 and Normal Saline in people with Rupture of Membranes Prior to Onset of Labor and Induction of Labor, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction-delivery time (time frame: From enrollment till fetus delivery, within 24-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.