Clinical trial

Azithromycin to Improve Latency in Exam Indicated Cerclage: a Randomized Control Trial

Name

21D.746

Description

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.

Trial arms

Trial start

2021-12-20

Estimated PCD

2024-12-01

Trial end

2025-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Azithromycin 1 gram IV

Perioperative addition of azithromycin at the time of physical exam indicated cerclage placement.

Arms:

Azithromycin + control

Cefazolin and indomethacin

Perioperative standard of care with cefazolin and indomethacin

Arms:

Azithromycin + control, Cefazolin and Indomethacin

Size

Primary endpoint

Gestational Latency Achieved Between Cerclage Placement and Time of Delivery

24 weeks following cerclage placement

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-06-26

1 organization

2 products

10 indications

Organization

Thomas Jefferson University

Product

Azithromycin

Indication

premature birth

Indication