Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

Condition
Preterm Birth
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

New Brunswick

Rutgers Robert Wood Johnson, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Thomas Jefferson University,

Jenani S Jayakumaran, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Rupsa Boelig, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

2025-06