Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study
Wake Forest University Health Sciences
Summary
The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.
Description
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 azi…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 chr…
Interventions
- DrugAzithromycin Prophylaxis
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
- DrugAzithromycin Placebo
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
- DrugCefazolin
All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.
Locations (2)
- Advocate Christ Medical CenterOak Lawn, Illinois
- Advocate Lutheran General HospitalPark Ridge, Illinois