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Chlorhexidine Vaginal and Infant Wash in Pakistan

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Alabama at Birmingham
Aga Khan University
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00121394
First received: July 15, 2005
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

Infection is a major health problem during birth in Pakistan. This study will look at the possibility of using a septic wash to help improve health during birth in Karachi, Pakistan.


Condition Intervention Phase
Sepsis
Pregnancy
Procedure: Chlorhexidine vaginal and infant wash
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Neonatal death or severe sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital [ Time Frame: 7 dats ] [ Designated as safety issue: No ]

Enrollment: 5008
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chlorhexidine Procedure: Chlorhexidine vaginal and infant wash

Detailed Description:

Sepsis in mother and infant is a major cause of perinatal morbidity and mortality in low-resource settings. Several studies have investigated the likelihood that an anti-bacterial agent, chlorhexidine, administered during labor and delivery to mother and infant could reduce the risk of infection and of subsequent maternal and infant morbidity and mortality. In this trial, chlorhexidine wash and placebo will be randomly administered to women in labor and newborn infants in a public hospital in Karachi, Pakistan.

Delivery attendants will administer 0.6% chlorhexidine solution every four hours until delivery (4 washes maximum) and one neonatal wash with the same solution. The control group will receive 200 ml of sterile physiologic saline solution. A total of 5000 women will be randomized in the hospital study, 2500 control and 2500 intervention. All women and infants will be evaluated 24 hours post delivery and at a 7-day follow-up. Women who delivered at home will also receive a 28 days post-partum assessment. Women will be carefully monitored for side effects to the dosage. In addition a community-based feasibility trial of 200 patients (100 CHX, 100 control) will be completed.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gravidas with living fetus delivering at home in the care of identified study birth attendant (community) or admitted to the identified hospital (Civil Hospital Karachi) for delivery

Exclusion Criteria:

  • Contraindications to cervical exam (e.g., placenta previa)
  • Active genital herpes or vulvovaginal ulceration
  • Known or suspected allergy to chlorhexidine
  • Fetus with face presentation
  • Fetal death
  • Unwilling/unable to give informed consent
  • Less than 16 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121394

Locations
Pakistan
Civil Hospital Karachi
Karachi, Pakistan
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Alabama at Birmingham
Aga Khan University
Investigators
Principal Investigator: Robert Goldenberg, M.D. Drexel University
Principal Investigator: Sarah Saleem, M.D. The Aga Khan University
  More Information

Additional Information:
No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00121394     History of Changes
Other Study ID Numbers: GN 09 A, U01HD040607
Study First Received: July 15, 2005
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Chlorhexidine
Vaginal wash
Neonatal mortality
Sepsis
Global Network
Maternal and child health
Women's Health
International
Pakistan

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014