Recruiting

Azithromycin

Sponsor:

Thomas Jefferson University

Code:

NCT05132829

Conditions

Preterm Birth

Obstetric Labor, Premature

Obstetric Labor Complications

Pregnancy Complications

Physiological Effects of Drugs

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Azithromycin 1 gram IV

Cefazolin and indomethacin

Study Details

Brief 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.

Conditions

Preterm Birth

Obstetric Labor, Premature

Obstetric Labor Complications

Pregnancy Complications

Physiological Effects of Drugs

Study ID

NCT05132829

Start date

Dec 20, 2021

Status verified date

Jun, 2023

Completion date

Jun, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cefazolin and Indomethacin

Control arm- perioperative cefazolin and indomethacin

experimental: Azithromycin + control

perioperative azithromycin, cefazolin and indomethacin

Interventions

Azithromycin 1 gram IV

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

Cefazolin and indomethacin

Perioperative standard of care with cefazolin and indomethacin

Primary outcome measure

  • Gestational Latency Achieved Between Cerclage Placement and Time of Delivery [ Time Frame: 24 weeks following cerclage placement ]

Central Contacts and Locations

Central contacts

Rupsa Boelig, MD

2159555000Rupsa.boelig@jefferson.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Rutgers Robert Wood Johnson

Recruiting

New Brunswick, New Jersey, United States, 08901

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jun 26, 2023

Last verified

Jun, 2023

Keywords

  • cerclage
  • preterm birth
  • premature cervical dilation
  • antibiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2023-06-26.