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Which antibiotic works best when water breaks early?

NCT ID NCT06273891

Disease control Sponsor: Inova Health Care Services 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two common antibiotics—erythromycin and azithromycin—in pregnant people whose water breaks too early (before 34 weeks). Both are given along with standard antibiotics. The goal is to see which combination helps delay delivery longer, giving the baby more time to develop. About 140 participants will be randomly assigned to one of the two treatments.

What this could mean

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

Active substance
Erythromycin or azithromycin (plus ampicillin and amoxicillin)
What this could lead to
If it works, this could help doctors choose the best antibiotic to delay delivery after preterm water break, potentially improving outcomes for babies.
What could go wrong
This is a relatively small trial (140 people) and only compares two accepted drugs, so it may not show a clear winner or change standard practice.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

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

Started

Mar 2024

Expected to finish

Oct 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 to 50 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: * Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation. * Rupture of membranes confirmed by biochemical testing. * Membrane rupture within the past 36 hours. * Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission. * Age ≥18 and \<50 years. Exclusion Criteria: * Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission. * Allergy to penicillin, erythromycin, or azithromycin. * Multiple gestations.

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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 membrane

Contacts and locations

Locations

  • Eastern Viriginia Medical School

    Norfolk, Virginia, 23507, United States

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States