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Labor drug may prevent birth injuries in new moms

NCT ID NCT07641543

Symptom relief Sponsor: Dr Raneen Abu Shqara Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a single dose of a muscle relaxant (papaverine) during labor can reduce the need for stitches after vaginal delivery in first-time mothers. About 412 women will receive either the drug or a placebo, and doctors will compare rates of tearing and other complications. The goal is to find a simple, safe way to lower the risk of perineal injury.

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 412 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

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: * Primiparous patients aged 18 years or older * Singleton pregnancy * Term pregnancy (37+0 to 42+0 weeks of gestation) * Cephalic presentation * Undergoing labor with at least with 2 cm cervical dilatation. * Ability to provide written informed consent Exclusion Criteria: * Multiple gestation * Major fetal congenital anomalies * Contraindication to vaginal delivery * Known hypersensitivity or allergy to papaverine hydrochloride * Known supraventricular tachycardia (SVT) * Maternal tachycardia (heart rate \>100 bpm) or clinically significant cardiac arrhythmia * Known liver disease or hepatic dysfunction * Active psychiatric condition impairing the ability to provide informed consent * Inability to provide written informed consent * Planned cesarean delivery

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As listed by the trial registrant

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

Obstetric anal sphincter injury Perineal trauma

How to take part

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

  1. 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 ↗

  2. 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.

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