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

NCT03248297 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2022-07-18

Study results available
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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.

Conditions

  • Postpartum Sepsis
  • Postpartum Endometritis
  • Postpartum Fever

Interventions

DRUG

Azithromycin

Azithromycin tablet

DRUG

Azithromycin and amoxicillin

azithromycin and amoxicillin

DRUG

Placebo

Placebo tablet

Sponsors & Collaborators

Principal Investigators

  • Alan Tita, MD, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2020-05-15
Completion
2020-10-01

Countries

  • Cameroon

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248297 on ClinicalTrials.gov