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Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn

NCT00136370 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2007-09-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.

Conditions

  • Infant, Newborn, Diseases
  • Sepsis
  • Puerperal Infection

Interventions

DRUG

Chlorhexidine

PROCEDURE

Birth canal wipe

PROCEDURE

sterile water external genital wipe

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • National Vaccine Program Office

    collaborator UNKNOWN

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Stephanie Schrag, DPhil · Centers for Disease Control and Prevention

  • Shabir Madhi, MD, PhD · Respiratory and Meningeal Pathogens Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Completion
2007-11-30

Countries

  • South Africa

Study Locations

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Entities

Diseases
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 NCT00136370 on ClinicalTrials.gov