Using azithromycin to help prevent preterm birth in at-risk pregnancies
Azithromycin to Improve Latency in Exam Indicated Cerclage: a Randomized Control Trial
This study is testing if giving the antibiotic azithromycin to pregnant women at risk of preterm birth can help them carry their babies longer before delivery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05132829 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of azithromycin, an antibiotic, in prolonging gestation when administered prior to an exam indicated cerclage in pregnant women at risk of preterm birth. The study focuses on women with singleton pregnancies who meet specific criteria for cervical cerclage placement due to cervical insufficiency. By investigating the role of antibiotics in this context, the trial aims to address a gap in current obstetric practices regarding preterm birth prevention. The methodology includes administering azithromycin alongside other treatments like cefazolin and indomethacin to assess their combined impact on pregnancy duration.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with singleton pregnancies and an estimated gestational age of less than 24 weeks who qualify for an exam indicated cerclage.
Not a fit: Patients who may not benefit from this study include those with HIV, major fetal congenital anomalies, or contraindications to the study medications.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing preterm birth, potentially reducing neonatal morbidity and mortality.
How similar studies have performed: Previous studies have shown some success with similar approaches, particularly in the context of using antibiotics to prolong pregnancy in at-risk populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Rutgers Robert Wood Johnson — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Jenani S Jayakumaran, MD — Thomas Jefferson University
- Study coordinator: Rupsa Boelig, MD
- Email: Rupsa.boelig@jefferson.edu
- Phone: 2159555000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.