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Clinical Trials/NCT01309321
NCT01309321CompletedNot Applicable

Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior

International Centre for Diarrhoeal Disease Research, Bangladesh1 site in 1 country400 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
1
Primary Endpoint
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Prior live birth

Arms & Interventions

Perinatal Handwashing Intervention Arm

Experimental

Intervention: Perinatal Handwashing Promotion (Behavioral)

Neonatal Health Promotion

Active Comparator

Intervention: Neonatal Health Promotion (Behavioral)

Outcomes

Primary Outcomes

Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

Time Frame: 3 months post-natal

Daily reduction in household soap weight.

Time Frame: 1 month post-natal

Daily reduction in household soap weight.

Time Frame: 2 weeks post-natal.

Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

Time Frame: 1 month post-natal

Secondary Outcomes

  • Incidence density of suspected sepsis in neonates(1 month post natal)
  • Incidence density of suspected omphalitis in neonates(1 month post-natal)
  • All cause neonatal mortality rate.(1 month post-natal.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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