CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 756 enrolled
Drug / intervention
Azithromycin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03248297
NCT03248297Phase 4Completed
CompareCT.gov

Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT

University of Alabama at Birmingham·interventional·Posted Aug 14, 2017·Updated Jul 18, 2022

In Brief

A Phase 4 clinical trial evaluating Azithromycin, Azithromycin and amoxicillin, and 1 other intervention for Postpartum Sepsis and 2 related conditions. Completed, enrolled 756 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Sepsis, Postpartum Endometritis, Postpartum Fever
CountriesCameroon
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 14, 2017
Enrollment StartJan 12, 2018
Primary CompletionMay 15, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.9 years ago

Interventions

Azithromycindrug

Azithromycin tablet

Azithromycin and amoxicillindrug

azithromycin and amoxicillin

Placebodrug

Placebo tablet