Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

NCT05132829 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 21D.746
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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; Uterine Cervical Incompetence; Anti-Bacterial Agents; Azithromycin; Cefazolin

Keywords

cerclage; preterm birth; premature cervical dilation; antibiotics

Outcome Measures

Primary Outcomes (1)

• Gestational Latency Achieved Between Cerclage Placement and Time of Delivery

  Mean gestational latency achieved Between Cerclage Placement and Time of Delivery

  24 weeks following cerclage placement

Secondary Outcomes (7)

• Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks

  at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement.

• Mean gestational age at delivery

  at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement.

• chorioamnionitis

  at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement.

• birth weight

  at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement.

• Admission to neonatal intensive care unit

  at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement.

Study Arms (2)

Cefazolin and Indomethacin

OTHER

Control arm- perioperative cefazolin and indomethacin

Drug: Cefazolin and indomethacin

Azithromycin + control

EXPERIMENTAL

perioperative azithromycin, cefazolin and indomethacin

Drug: Azithromycin 1 gram IV; Drug: Cefazolin and indomethacin

Interventions

Azithromycin 1 gram IV DRUG

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

Azithromycin + control

Cefazolin and indomethacin DRUG

Perioperative standard of care with cefazolin and indomethacin

Azithromycin + control; Cefazolin and Indomethacin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rutgers Robert Wood Johnson

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (1)

• Jayakumaran JS, Khanuja K, Fischer SA, Miller ES, Rosenfeld EB, Brandt JS, Piacquadio M, Kalifeh A, Boelig RC. Azithromycin to improve latency in exam-indicated cerclage: A multicenter randomized controlled trial (ALEC). Am J Obstet Gynecol MFM. 2025 Oct 22:101818. doi: 10.1016/j.ajogmf.2025.101818. Online ahead of print.

  PMID: 41135925 DERIVED

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Uterine Cervical Incompetence

Interventions

Cefazolin; Indomethacin

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Indoles

Study Officials

• Jenani S Jayakumaran, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Rupsa Boelig, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupsa Boelig, MD

CONTACT

2159555000; Rupsa.boelig@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 24, 2021
• Study Start: December 20, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (2)