Azithromycin for Cerclage Prophylaxis

Official title

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

Overview

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

Detailed 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 azithromycin prophylaxis (control group). Both groups will receive otherwise usual care.

Interventions

• Drug Azithromycin Prophylaxis
  500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
• Drug Azithromycin Placebo
  normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
• Drug Cefazolin
  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.
• Drug Progesterone
  progesterone 200 mg nightly after cerclage placement until 36 weeks gestation

Primary outcome measures

• Latency from Cerclage to Delivery [Time frame: Up to Week 42]
• Gestational Age at Delivery [Time frame: Up to Week 42]

Secondary outcome measures (5)

• Incidence of Chorioamnionitis [Time frame: Up to Week 42]
• Incidence of Preterm Premature Birth [Time frame: 28 weeks gestation, 34 weeks gestation, 37 weeks gestation]
• Incidence of Preterm Premature Rupture of Membranes [Time frame: up to 37 weeks gestation]
• Complications from Cerclage [Time frame: Up to Week 42]
• Prevalence of Mycoplasma Infection or Colonization [Time frame: Up to Week 42]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Advocate Christ Medical Center — Oak Lawn
• Advocate Lutheran General Hospital — Park Ridge

Identifiers

NCT: NCT07608562 · IRB00131410

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗