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When waters break early, does acting fast beat waiting?

NCT ID NCT07802041

Disease control Sponsor: Pakistan Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial studies women whose water breaks before labor starts, a condition called premature rupture of membranes, at 37 to 42 weeks of pregnancy. Half the participants will have labor induced within 24 hours using a vaginal gel, while the other half will wait up to 24 hours for labor to begin on its own. Researchers will compare the rates of cesarean delivery, uterine infection, and fetal distress between the two groups. The goal is to find out whether planned early induction leads to fewer complications for mothers and babies than waiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Induction of labor with prostaglandin E2 vaginal gel within 24 hours of diagnosis, compared with expectant management (observation for 24 hours with monitoring).
What this could lead to
If early induction works better, it could reduce infections and fetal distress in women whose water breaks before labor starts, and lower the need for cesarean sections.
What could go wrong
This is a single-center trial, and the results may not apply everywhere. Inducing labor can sometimes increase the chance of a cesarean, and the trial is still testing which approach is safer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 734 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women age 18 to 45 years * Singleton pregnancy on ultrasound * Gestational age 37 to 42 weeks on LMP * Any parity * Premature rupture of membrane as per operational definition Exclusion Criteria: * H/o active infection. * H/o placental abruption * H/o preeclampsia * Fetal anomalies on ultrasound

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Conditions

The condition(s) this trial relates to.

chorioamnionitis Fetal Membranes, Premature Rupture preterm premature rupture of the membranes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Premature rupture of membranes (PROM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pakistan institute of medical sciences Islamabad

    Islamabad, Pakistan

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