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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

July 15, 2005
July 29, 2014
June 2005
June 2008   (final data collection date for primary outcome measure)
Neonatal death or severe sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Neonatal death or severe sepsis at 7 days
Complete list of historical versions of study NCT00121394 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death
  • Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital
Not Provided
Not Provided
 
Chlorhexidine Vaginal and Infant Wash in Pakistan
Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Sepsis
  • Pregnancy
Procedure: Chlorhexidine vaginal and infant wash
Experimental: Chlorhexidine
Intervention: Procedure: Chlorhexidine vaginal and infant wash

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5008
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00121394
GN 09 A, U01HD040607
Yes
NICHD Global Network for Women's and Children's Health
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
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Robert Goldenberg, M.D. Drexel University
Principal Investigator: Sarah Saleem, M.D. The Aga Khan University
NICHD Global Network for Women's and Children's Health
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP