Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

Phase 4 Unknown 50 enrolled Thomas Jefferson University

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2021-12-20
Primary completion: 2024-12
Completion: 2025-06

Outcome

Missed primary endpoint

paper delivery did not differ between the intervention and control groups (92 days [interquartile range, 45-118] vs 85 [interquartile range, 20-123] days, respectively; P=.93). PMID 41135925 ↗

Publications

Jayakumaran JS, Khanuja K, Fischer SA, Miller ES, Rosenfeld EB, Brandt JS, Piacquadio M, Kalifeh A, Boelig RC. Azithromycin to improve latency in examination-indicated cerclage: a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2026 Apr;8(4):101818. doi: 10.1016/j.ajogmf.2025.101818. Epub 2025 Oct 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	1 g	Intravenous
Background	Cefazolin	Small molecule	1 g	Intravenous
Background	Cefazolin	Small molecule	2 g	Intravenous
Background	Indomethacin	Small molecule	50 mg	—