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New antibiotic cocktail aims to delay preterm birth after water breaks

NCT ID NCT06396078

Disease control Sponsor: Ohio State University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a 7-day course of three antibiotics (ceftriaxone, clarithromycin, metronidazole) can prolong pregnancy better than the current standard antibiotics in pregnant people hospitalized after their water breaks early (before 34 weeks). About 56 participants will be randomly assigned to one of the two antibiotic regimens. The goal is to see if the new combination delays delivery and reduces serious health problems for the newborn.

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 56 people

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

Started

Jul 2024

Expected to finish

Dec 2026

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

18 years and older

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 * Admitted to the inpatient unit for expectant management of PPROM until delivery * Age ≥ 18 years with the ability to provide informed consent * Gestational age between 23 0/7 and 32 6/7 weeks Exclusion criteria * Having received more than one dose of any prophylactic antibiotic * Suspected or confirmed infection requiring treatment with antibiotics * Allergy or contraindication to an antibiotic in either arm * Maternal immunosuppression

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Conditions

The condition(s) this trial relates to.

chorioamnionitis Premature Birth preterm premature rupture of the membranes

As listed by the trial registrant

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

Pregnancy, high risk Preterm birth Preterm premature rupture of membrane

How to take part

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

  1. The places running it

    2 sites. 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 Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 775555, United States

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