Azithromycin for Cerclage Prophylaxis

Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

The overall objective of this prospective two-arm randomized study is to (1) randomize subjects to azithromycin surgical prophylaxis versus placebo, plus the standard of care - cefazolin, at the time of cerclage placement and evaluate the impact on preterm delivery <37 weeks, <34 weeks and <28 weeks and (2) determine the prevalence of mycoplasma species in cerclage patients. Pregnant women who are candidates for cervical cerclage will be enrolled and divided into two cohorts (approximately 40 per group): (1) Cerclage + Azithromycin prophylaxis (treatment group), and (2) Cerclage without azithromycin prophylaxis (control group). Both groups will receive otherwise usual care.

Inclusion Criteria:

• Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment
• Indication for transvaginal cerclage placement
• Intact amniotic membranes

Exclusion Criteria:

• Evidence of active infection or chorioamnionitis at presentation
• Preterm prelabor rupture of membranes (PPROM)
• Multiple gestation
• HIV positive status
• Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)
• Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)
• Major fetal anomaly or known chromosomal abnormalities that significantly affect viability
• Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage