Pregnancy Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 5008 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Pakistan | Civil Hospital Karachi | Karachi |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Aga Khan University, Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Global Network for Women's and Children's Health Research, RTI International, University of Alabama at Birmingham |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal death or severe sepsis | 7 days | No | |
Secondary | Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death | 7 days | No | |
Secondary | Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital | 7 dats | No |
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