Could a common antibiotic prevent early birth in High-Risk pregnancies?

NCT ID NCT07608562

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether giving the antibiotic azithromycin before a cervical stitch (cerclage) can help high-risk pregnancies last longer. About 80 pregnant women with a weak cervix will receive either azithromycin or a placebo, plus standard care. The goal is to see if the antibiotic reduces infections and delays delivery.

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 help high-risk pregnancies last longer and reduce complications like preterm birth.
What could go wrong: This is a small early-phase trial, so results may not apply widely. Azithromycin can cause side effects like nausea or allergic reactions.

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 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

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: * Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment * Indication for transvaginal cerclage placement * Intact amniotic membranes Exclusion Criteria: * Evidence of active infection or chorioamnionitis at presentation * Preterm prelabor rupture of membranes (PPROM) * Multiple gestation * HIV positive status * Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin) * Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome) * Major fetal anomaly or known chromosomal abnormalities that significantly affect viability * Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage

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Conditions

The condition(s) this trial relates to.

cervical incompetence

As listed by the trial registrant

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

Cervical insufficiency

How to take part

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

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.

Could a common antibiotic prevent early birth in High-Risk pregnancies?

What the study statuses mean