Clinical trial NCT01309321: Perinatal Handwashing Intervention in Bangladesh
Official title: Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Umbilical Cord
Infection
Keywords: Perinatal
Handwashing
Neonatal
Morbidity
Mortality
Primiparous
Health behavior
Developing countries
Sepsis
Omphalitis
Infectious disease
Bangladesh
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: State University of New York at Buffalo
name: Centers for Disease Control and Prevention
First posted: 2011-03-07
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: In high neonatal mortality settings, about half of neonatal deaths are estimated to occur because of infectious syndromes such as sepsis, acute respiratory infection, neonatal tetanus, and diarrhea. Promoting handwashing to mothers in the post-neonatal period has been shown to reduce the risk of pneumonia and diarrhea among infants \> 28 days old but there is little information on the protective effect of handwashing for neonatal health outcomes. The proposed study will assess motivators and barriers to handwashing with soap among new mothers, and develop and test a hand cleansing promotion intervention in rural Bangladesh. The handwashing behavior change intervention will include approaches to enhance maternal expectations of being a good nurturer, as well as enhancing maternal self-efficacy to carry out handwashing behavior.

Eligibility criteria: Inclusion Criteria:

* Primiparous women who plan to remain in the study area up to 1 months after birth

Exclusion Criteria:

* Prior live birth

Primary outcomes:
measure: Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
timeFrame: 1 month post-natal
measure: Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
timeFrame: 3 months post-natal
measure: Daily reduction in household soap weight.
timeFrame: 2 weeks post-natal.
measure: Daily reduction in household soap weight.
timeFrame: 1 month post-natal
Secondary outcomes:
measure: Incidence density of suspected sepsis in neonates
timeFrame: 1 month post natal
measure: Incidence density of suspected omphalitis in neonates
timeFrame: 1 month post-natal
measure: All cause neonatal mortality rate.
timeFrame: 1 month post-natal.
Other outcomes:
Locations:
city: Matlab
country: Bangladesh
facility: ICDDR,B
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Sharifa Nasreen, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York at Buffalo
name: Pavani K. Ram, MD
role: PRINCIPAL_INVESTIGATOR
References: