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Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

NCT05132829 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-06-26

No results posted yet for this study

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

Interventions

DRUG

Azithromycin 1 gram IV

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

DRUG

Cefazolin and indomethacin

Perioperative standard of care with cefazolin and indomethacin

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Jenani S Jayakumaran, MD · Thomas Jefferson University

  • Rupsa Boelig, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132829 on ClinicalTrials.gov