Summary

Eligibility
for females (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.

Official Title

Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial

Details

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either azithromycin prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin, 2) to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo, and 3) to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo.

Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.

Keywords

Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery, infection, maternal morbidity, antibiotics, prevention, Anti-Bacterial Agents, Azithromycin, Azithromycin Injection

Eligibility

You can join if…

Open to females

  • ≥ 23 weeks' gestation (ACOG dating criteria)
  • Scheduled or prelabor cesarean delivery
  • Singleton or twin gestation

You CAN'T join if...

  • Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  • Chorioamnionitis
  • Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
  • Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
  • Fetal demise or known major congenital anomaly
  • Azithromycin treatment within 7 days
  • Planned use of antimicrobial prophylaxis after delivery for any reason
  • Known structural heart disease or active cardiomyopathy (current ejection fraction<40%)
  • Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
  • Refusal or unable to obtain consent (e.g., language barrier)
  • Participating in another intervention study that influences the primary outcome in this study
  • Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.

Locations

  • Regents of the UCSF
    San Francisco California 94143 United States
  • University of Utah
    Salt Lake City Utah 84132 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
The George Washington University Biostatistics Center
ID
NCT06605118
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 8000 study participants
Last Updated