RECRUITING

Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-12-20
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05132829

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women with singleton pregnancies
  2. * ≥18 years old
  3. * Estimated gestational age less than 24 weeks
  4. * Meet criteria for an exam indicated cerclage
  5. * Patients must also be able to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
  1. * Human immunodeficiency virus (HIV) positive status
  2. * Known prolonged QT syndrome
  3. * Major fetal congenital anomalies
  4. * Temperature of 100.4 F or higher
  5. * Prior cerclage during the current pregnancy
  6. * Contraindication to indomethacin
  7. * Allergy to both penicillin and clindamycin
  8. * Received indomethacin or any antibiotics within 7 days before their presentation

Contacts and Locations

Study Contact

Rupsa Boelig, MD
CONTACT
2159555000
Rupsa.boelig@jefferson.edu

Principal Investigator

Jenani S Jayakumaran, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Rupsa Boelig, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States
Rutgers Robert Wood Johnson
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

  • Jenani S Jayakumaran, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University
  • Rupsa Boelig, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

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

Study Start Date2021-12-20
Study Completion Date2025-06

Study Record Updates

Study Start Date2021-12-20
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • cerclage
  • preterm birth
  • premature cervical dilation
  • antibiotics

Additional Relevant MeSH Terms

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