Sepsis Clinical Trial
Official title:
Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior
The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.
Status | Completed |
Enrollment | 400 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Primiparous women who plan to remain in the study area up to 1 months after birth Exclusion Criteria: - Prior live birth |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Bangladesh | ICDDR,B | Matlab |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | Centers for Disease Control and Prevention, State University of New York at Buffalo |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change. | 1 month post-natal | No | |
Primary | Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change. | 3 months post-natal | No | |
Primary | Daily reduction in household soap weight. | 2 weeks post-natal. | No | |
Primary | Daily reduction in household soap weight. | 1 month post-natal | No | |
Secondary | Incidence density of suspected sepsis in neonates | 1 month post natal | No | |
Secondary | Incidence density of suspected omphalitis in neonates | 1 month post-natal | No | |
Secondary | All cause neonatal mortality rate. | 1 month post-natal. | No |
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