Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Amoxicillin; Azithromycin

Criteria

Inclusion Criteria:

• Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with

1. Prolonged membrane rupture (≥8 hours) or

2. Prolonged labor (≥18 hours).

Exclusion Criteria:

• Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.

• Allergy to azithromycin or amoxicillin

• Plan for cesarean delivery prior to enrollment

• Fetal demise or major congenital anomaly: Major congenital anomalies may confound assessment of neonatal outcomes and every attempt will be made up front to exclude them from randomization. However, some unrecognized fetal anomalies may inevitably be randomized. These will not be excluded post-randomization from the primary (maternal outcome) analysis; they will be taken into consideration in the secondary analyses of neonatal outcomes.