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Antibiotics for early water break study halted before start

NCT ID NCT06917157

Knowledge-focused Sponsor: The University of Texas Health Science Center, Houston 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 aimed to see if giving antibiotics to pregnant people whose water broke very early (before 22 weeks) could delay delivery and improve baby health. It was planned for those with a single baby and recent membrane rupture. However, the study was withdrawn before enrolling anyone, so no results are available.

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.

Expected to start

May 2025

An estimate. Start dates often move.

Expected to finish

May 2027

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: * Preterm premature rupture of membranes at less than 22 weeks. * Membrane rupture had occurred within 36 hours of randomization. * Cervical dilatation is 3 cm or less (on visual or clinical examination). * 4 or fewer contractions in the 60-minute monitoring period before randomization. * Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age * Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information. Exclusion Criteria: * Nonreasoning fetal testing * Vaginal bleeding * Maternal or fetal indication for immediate delivery * Cervical cerclage in place * Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin) * Allergy to Penicillins or Azithromycin * Febrile illness requiring antibiotics * Placenta previa * Multifetal gestation

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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.

Preterm prelabor rupture of membranes (pprom)