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

Last updated: March 18, 2022
Sponsor: University of Alabama at Birmingham
Overall Status: Completed

Phase

4

Condition

Gynecological Infections

Endometriosis

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT03248297
CHI UAB MISP # 54628
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginaldelivery with
  1. Prolonged membrane rupture (≥8 hours) or
  2. Prolonged labor (≥18 hours).

Exclusion

Exclusion Criteria:

  • Clinical chorioamnionitis or any other active bacterial infection (e.g.pyelonephritis, pneumonia, abscess) at time of randomization: because standardantibiotic 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 confoundassessment of neonatal outcomes and every attempt will be made up front to excludethem from randomization. However, some unrecognized fetal anomalies may inevitably berandomized. These will not be excluded post-randomization from the primary (maternaloutcome) analysis; they will be taken into consideration in the secondary analyses ofneonatal outcomes.

Study Design

Total Participants: 756
Study Start date:
January 12, 2018
Estimated Completion Date:
October 01, 2020

Study 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 placebo for the prevention of peripartum infections and sepsis in laboring women. We have previously shown the effectiveness of azithromycin for extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for reduction of post-cesarean infections. In LICs, the fraction of maternal infection and sepsis from cesarean delivery is minimal. Therefore, it is necessary to evaluate strategies aimed at reducing these morbidities in women who have vaginal births. There is an increased risk of infection in women who have prolonged labor or prolonged rupture of membranes. Drawing from our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery, we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or without oral amoxicillin) to prevent maternal peripartum infection and sepsis. 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 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin, compared to usual care (placebo). Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Connect with a study center

  • Cameroon Baptist Convention Health Services

    Bamenda,
    Cameroon

    Site Not Available

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