Perinatal Handwashing Intervention in Bangladesh

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis, Umbilical Cord, Infection

Intervention / Treatment
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* Behavioral: Perinatal Handwashing Promotion
* Behavioral: Neonatal Health Promotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primiparous women who plan to remain in the study area up to 1 months after birth Exclusion Criteria: Prior live birth
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perinatal Handwashing Intervention Arm<br> | Behavioral: Perinatal Handwashing Promotion<br>* Pregnancy may serve as a unique opportunity to improve maternal handwashing behavior more deeply and sustainably than a handwashing promotion intervention at a different time. Primiparous women will receive an intensive handwashing promotion program delivered at 3 in-home visits between one month prenatal and 1 week post natal. The program will promote handwashing benefits, provide hardware to reduce barriers to handwashing, and educate mothers about the critical times for handwashing. Mothers will also receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.<br>|
| Active Comparator: Neonatal Health Promotion<br> | Behavioral: Neonatal Health Promotion<br>* Mothers will receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change. |  | 1 month post-natal | 
| 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. |  | 2 weeks post-natal. | 
| Daily reduction in household soap weight. |  | 1 month post-natal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal, Handwashing, Neonatal, Morbidity, Mortality, Primiparous, Health behavior, Developing countries, Sepsis, Omphalitis, Infectious disease, Bangladesh