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 range18 Years – 80 Years

SexFEMALE

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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

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