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Simple antibiotic pill may protect mothers and babies during induced labor

NCT ID NCT06543290

Disease control Sponsor: Arrowhead Regional Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This study tests whether giving a single 2-gram dose of azithromycin before starting labor induction can lower the risk of infections in both the mother and newborn. Researchers plan to enroll 400 pregnant women in their third trimester who are scheduled for labor induction. Half will receive the antibiotic and half a placebo, and the rates of infections like chorioamnionitis will be compared.

What this could mean

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

Active substance
azithromycin
What this could lead to
If it works, this could provide a simple, low-cost way to prevent serious infections during childbirth.
What could go wrong
This is an early Phase 1 trial, so the results are uncertain. The drug may not reduce infections as hoped, and side effects are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 400 people

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

Started

Aug 2023

Expected to finish

Aug 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 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * • Third trimester of pregnancy defined as 28 0/7 weeks or more * Singleton pregnancy * Age 18-45 * Induction of labor initiated for medical or obstetrical reason or electively over 39 weeks of gestation * No contraindication to vaginal delivery * Reassuring fetal heart rate tracing * Able and willing to provide informed consent Exclusion Criteria: * • Does not read or write in English or Spanish * Unable or unwilling to give informed consent * Use of antibiotic or antiviral agent within the last 7 days * Evidence of active infection at the time of initiation of induction (patients with rectovaginal group B streptococcus positive results will be allowed to participate as it is a colonizing organism, unless they show evidence of active infection) * Incarcerated Women * Active substance abuse * Age \< 18

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Conditions

The condition(s) this trial relates to.

Infections infectious disease chorioamnionitis prevention target

As listed by the trial registrant

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

Infections

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

  • Arrowhead Regional Medical Center

    RECRUITING

    Colton, California, 92324, United States

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