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Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial
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
More conditions available...
🗓️ Study Start (Actual) 20 December 2021
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Chicago, Illinois, United States
📍 New Brunswick, New Jersey, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 October 2021
  • First Submitted that Met QC Criteria 12 November 2021
  • First Posted 24 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 June 2023
  • Last Update Posted 26 June 2023
  • Last Verified June 2023
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