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Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality

16 Years
Not Enrolling
Sepsis, Pregnancy

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Trial Information

Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Outcome Measure:

Neonatal death or severe sepsis at 7 days

Principal Investigator

Robert Goldenberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Drexel University


United States: Federal Government

Study ID:

GN 09 A



Start Date:

June 2005

Completion Date:

June 2008

Related Keywords:

  • Sepsis
  • Pregnancy
  • Chlorhexidine
  • Vaginal wash
  • Neonatal mortality
  • Sepsis
  • Global Network
  • Maternal and child health
  • Women's Health
  • International
  • Pakistan
  • Sepsis