UnknownPhase 4

Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

United States50 participantsStarted 2021-12-20

Plain-language summary

Azithromycin is an antibiotic that is effective against bacteria that been associated with preterm birth (PTB). The purpose of this study is to evaluate if the addition of azithromycin prior to exam indicated cerclage prolongs gestation. A cerclage is a suture placed in the cervix to prolong gestation.

Who can participate

Age range

18 Years – 80 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: * Pregnant women with singleton pregnancies * ≥18 years old * Estimated gestational age less than 24 weeks * Meet criteria for an exam indicated cerclage * Patients must also be able to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. Exclusion Criteria: * Human immunodeficiency virus (HIV) positive status * Known prolonged QT syndrome * Major fetal congenital anomalies * Temperature of 100.4 F or higher * Prior cerclage during the current pregnancy * Contraindication to indomethacin * Allergy to both penicillin and clindamycin * Received indomethacin or any antibiotics within 7 days before their presentation

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

Gestational Latency Achieved Between Cerclage Placement and Time of Delivery

Timeframe: 24 weeks following cerclage placement

Trial details

NCT IDNCT05132829

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Rupsa Boelig, MD

2159555000 Rupsa.boelig@jefferson.edu

View on ClinicalTrials.gov More Preterm Birth trials