Perinatal Handwashing Intervention in Bangladesh

Not Applicable

Completed

• Conditions: Sepsis; Umbilical Cord; Infection
• Interventions: Behavioral: Perinatal Handwashing Promotion; Behavioral: Neonatal Health Promotion

• Registration Number: NCT01309321
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

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 Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• Prior live birth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perinatal Handwashing Intervention Arm	Perinatal Handwashing Promotion	-
Neonatal Health Promotion	Neonatal Health Promotion	-

Primary Outcome Measures

Name	Time	Method
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.	3 months post-natal
Daily reduction in household soap weight.	1 month post-natal

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

ICDDR,B; 🇧🇩 Matlab, Bangladesh