Perinatal Handwashing Intervention in Bangladesh
Primary Purpose
Sepsis, Umbilical Cord, Infection
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Perinatal Handwashing Promotion
Neonatal Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for Sepsis focused on measuring Perinatal, Handwashing, Neonatal, Morbidity, Mortality, Primiparous, Health behavior, Developing countries, Sepsis, Omphalitis, Infectious disease, Bangladesh
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
Sites / Locations
- ICDDR,B
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Perinatal Handwashing Intervention Arm
Neonatal Health Promotion
Arm Description
Outcomes
Primary Outcome Measures
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Daily reduction in household soap weight.
Daily reduction in household soap weight.
Secondary Outcome Measures
Incidence density of suspected sepsis in neonates
Incidence density of suspected omphalitis in neonates
All cause neonatal mortality rate.
Full Information
NCT ID
NCT01309321
First Posted
October 7, 2010
Last Updated
March 12, 2014
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
State University of New York at Buffalo, Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01309321
Brief Title
Perinatal Handwashing Intervention in Bangladesh
Official Title
Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
State University of New York at Buffalo, Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Umbilical Cord, Infection
Keywords
Perinatal, Handwashing, Neonatal, Morbidity, Mortality, Primiparous, Health behavior, Developing countries, Sepsis, Omphalitis, Infectious disease, Bangladesh
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perinatal Handwashing Intervention Arm
Arm Type
Experimental
Arm Title
Neonatal Health Promotion
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Perinatal Handwashing Promotion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neonatal Health Promotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Time Frame
1 month post-natal
Title
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Time Frame
3 months post-natal
Title
Daily reduction in household soap weight.
Time Frame
2 weeks post-natal.
Title
Daily reduction in household soap weight.
Time Frame
1 month post-natal
Secondary Outcome Measure Information:
Title
Incidence density of suspected sepsis in neonates
Time Frame
1 month post natal
Title
Incidence density of suspected omphalitis in neonates
Time Frame
1 month post-natal
Title
All cause neonatal mortality rate.
Time Frame
1 month post-natal.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharifa Nasreen, MBBS, MPH
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pavani K. Ram, MD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDR,B
City
Matlab
Country
Bangladesh
12. IPD Sharing Statement
Learn more about this trial
Perinatal Handwashing Intervention in Bangladesh
We'll reach out to this number within 24 hrs