Chlorhexidine Vaginal and Infant Wash in Pakistan
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.
Procedure: Chlorhexidine vaginal and infant wash
|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|
- Neonatal death or severe sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||June 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
|Experimental: Chlorhexidine||Procedure: Chlorhexidine vaginal and infant wash|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121394
|Civil Hospital Karachi|
|Principal Investigator:||Robert Goldenberg, M.D.||Drexel University|
|Principal Investigator:||Sarah Saleem, M.D.||The Aga Khan University|