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Can an old blood vessel drug shorten labour when waters break at term?

NCT ID NCT07826533

Symptom relief Sponsor: Wolfson Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

When a woman's waters break at term but labour has not started, doctors often use oxytocin to get contractions going. This trial tests whether adding a single intravenous dose of papaverine, a drug that relaxes smooth muscle, helps oxytocin work faster. Two hundred women with term premature rupture of membranes will receive either papaverine or a saline placebo one hour after oxytocin starts. Researchers will measure the time from the infusion to delivery, along with how the baby is born and the health of mother and newborn.

What this could mean

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

Active substance
papaverine, an older drug that relaxes blood vessels and smooth muscle, given as a single intravenous infusion alongside oxytocin
What this could lead to
If it helps, this could offer a simple, low-cost way to shorten labour for women whose waters break at term, potentially lowering the chance of infection for mother and baby.
What could go wrong
Papaverine can affect blood pressure and heart rhythm, so it may not be safe or effective for everyone. The trial is small, and any benefit on delivery time may not translate into better outcomes for mothers or newborns.

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 200 people

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

Started

Mar 2025

Expected to finish

Apr 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Age ≥18 years * Gestational age ≥37 weeks with term PROM * No active contractions * Cervical dilation \<2 cm * Vertex presentation * PROM duration between 2 and 12 hours Exclusion Criteria: * Previous cesarean delivery * Contraindication to vaginal delivery * Known fetal malformation * Known allergy to papaverine * Cardiac arrhythmia * Glaucoma * Hepatitis or other hepatic disease * Atrioventricular (AV) block * Congestive heart disease * Recent ischemic heart disease * Increased intracranial pressure * Active labor, defined as cervical dilation ≥6 cm * Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine

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Conditions

The condition(s) this trial relates to.

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 fetal membranes

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • The Edith Wolfson Medical Center

    RECRUITING

    Holon, 5822012, Israel

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