Perinatal Handwashing Intervention in Bangladesh

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Infection; Umbilical Cord
• Intervention / Treatment: Behavioral: Perinatal Handwashing Promotion; Behavioral: Neonatal Health Promotion

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Matlab, Bangladesh
    • Icddr,b

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Prior live birth

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perinatal Handwashing Intervention Arm	Behavioral: Perinatal Handwashing Promotion; 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.
Active Comparator: Neonatal Health Promotion	Behavioral: Neonatal Health Promotion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: Centers for Disease Control and Prevention; State University of New York at Buffalo
• Investigators: Principal Investigator: Sharifa Nasreen, MBBS, MPH, International Centre for Diarrhoeal Disease Research, Bangladesh; Principal Investigator: Pavani K. Ram, MD, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 7, 2011

Study Record Updates

• Last Update Posted (Estimate): March 13, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Morbidity; Sepsis; Mortality; Developing countries; Bangladesh; Neonatal; Infectious disease; Perinatal; Handwashing; Health behavior; Omphalitis; Primiparous
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: PR-10036