Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Azithromycin; Cefazolin; Indomethacin

Criteria

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