Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

Status unconfirmed · Phase 4

Conditions studied: Preterm Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications, Physiological Effects of Drugs, Uterine Cervical Incompetence, Anti-Bacterial Agents, Azithromycin, Cefazolin

In brief

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.

Key facts

Study ID

NCT05132829

Run by

Thomas Jefferson University

People needed

50

Starts

2021-12-20

Expected to finish

2025-06-01

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)
• Rutgers Robert Wood Johnson — New Brunswick, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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