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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
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.
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Latency from Cerclage to Delivery
Number of days from cerclage to delivery
Time frame: Up to Week 42
Gestational Age at Delivery
Gestational age at delivery measured in weeks and days
Time frame: Up to Week 42
Incidence of Chorioamnionitis
number of participants with chorioamnionitis
Time frame: Up to Week 42
Incidence of Preterm Premature Birth
Number of participants that experienced preterm premature birth
Time frame: 28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Incidence of Preterm Premature Rupture of Membranes
Number of participants that experienced preterm premature rupture of membranes
Time frame: up to 37 weeks gestation
Complications from Cerclage
Number participants that experienced complications from cerclage
Time frame: Up to Week 42
Prevalence of Mycoplasma Infection or Colonization
Number of participants with prevalence of mycoplasma infection or colonization
Time frame: Up to Week 42
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