Status:
COMPLETED
Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Postpartum Sepsis
Postpartum Endometritis
Eligibility:
FEMALE
Phase:
PHASE4
Brief 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...
Detailed Description
This 3-arm study is a large randomized clinical trial designed to evaluate the comparative effectiveness and safety of single dose oral azithromycin or combined azithromycin+amoxicillin compared to pl...
Eligibility Criteria
Inclusion
- Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with
- Prolonged membrane rupture (≥8 hours) or
- Prolonged labor (≥18 hours).
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT03248297
Start Date
January 12 2018
End Date
October 1 2020
Last Update
July 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cameroon Baptist Convention Health Services
Bamenda, Cameroon