Not Yet RecruitingPhase 4

Azithromycin for Cerclage Prophylaxis

United States80 participantsStarted 2026-08

Plain-language summary

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Latency from Cerclage to Delivery

Timeframe: Up to Week 42

Gestational Age at Delivery

Timeframe: Up to Week 42

Trial details

NCT IDNCT07608562

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Rachel Harrison, MD

616-218-2892 rachel.harrison@aah.org

View on ClinicalTrials.gov More Cervical Insufficiency trials