Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Launched by THE GEORGE WASHINGTON UNIVERSITY BIOSTATISTICS CENTER · Sep 17, 2024

Keywords

ClinConnect Summary

The Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial is a clinical study aimed at understanding whether giving the antibiotic azithromycin before a scheduled cesarean delivery can help prevent infections in new mothers. The trial includes about 8,000 women who are at least 23 weeks pregnant and planning to have a cesarean delivery. Participants will receive either azithromycin or a placebo (which looks like the medication but has no effect) in addition to standard antibiotics usually given before surgery. Researchers will monitor the participants for up to six weeks after delivery to see if they develop any infections, such as wound infections or pneumonia.

To be eligible for this study, women must be expecting a single baby or twins and must be having a planned cesarean delivery. However, those with certain conditions, such as allergies to azithromycin or known infections requiring treatment, will not be able to participate. If you join this trial, you’ll receive care from your healthcare team, and you’ll be helping researchers learn more about how to reduce infection risks after cesarean deliveries. Your participation could contribute to improved health outcomes for future mothers.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • ≥ 23 weeks' gestation (ACOG dating criteria)
• • Scheduled or prelabor cesarean delivery
• • Singleton or twin gestation
• Exclusion Criteria:
• • 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.