Chlorhexidine Vaginal and Infant Wash in Pakistan
Information source: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis; Pregnancy
Intervention: Chlorhexidine vaginal and infant wash (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: NICHD Global Network for Women's and Children's Health Official(s) and/or principal investigator(s): Robert Goldenberg, M.D., Principal Investigator, Affiliation: Drexel University Sarah Saleem, M.D., Principal Investigator, Affiliation: The Aga Khan University
Summary
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.
Clinical Details
Official title: Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Neonatal death or severe sepsis
Secondary outcome: Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, deathNeonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital
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
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Civil Hospital Karachi, Karachi, Pakistan
Additional Information
Global Network for Women's and Children's Health Research Research Triangle Institute International Aga Khan University, Pakistan
Starting date: June 2005
Last updated: July 29, 2014
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