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Could extra antibiotics help prolong pregnancy after early water break?

NCT ID NCT07669207

Disease control Sponsor: Alexa Henderson 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This pilot study tests whether adding extra doses of the antibiotic azithromycin to standard care can improve outcomes for pregnant people whose water breaks very early (between 22 and 28 weeks). Thirty participants will be randomly assigned to receive either the standard antibiotic regimen or the standard plus seven additional azithromycin doses. The main goal is to see if such a study is feasible, not yet to prove the treatment works.

What this could mean

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

Active substance
Azithromycin (antibiotic)
What this could lead to
If it works, this could point toward a better antibiotic regimen to prolong pregnancy and improve outcomes after preterm membrane rupture.
What could go wrong
This is a very small pilot study (30 people) focused on feasibility, not effectiveness. It may not show clear benefits, and extra antibiotics could increase side effects or bacterial resistance.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

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

Started

Aug 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Singleton gestation * Gestational age at time of PPROM between 22w0d and 28w0d * Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care) * Remain pregnant 48 hours after presentation. * Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included. * Pregnant patients below the age of 18 are eligible. Exclusion Criteria: * Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption) * Lethal congenital defects * Multiple gestation * Ongoing alternative antibiotic treatment * Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic * History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin * Known prolongation of QT interval * History of torsades de pointes * Congenital long QT syndrome * Bradyarrhythmia * Decompensated heart failure * Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents * Impaired hepatic function * GFR\<10 mL/min * Diagnosis of myasthenia gravis

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Conditions

The condition(s) this trial relates to.

preterm premature rupture of the membranes

As listed by the trial registrant

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

PPROM Preterm prelabor rupture of 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

  • University of Pittsburgh Magee-Womens Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15217, United States

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