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Perinatal Handwashing Intervention in Bangladesh

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01309321
Enrollment
400
Registered
2011-03-07
Start date
2010-10-31
Completion date
2013-07-31
Last updated
2014-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Sepsis, Umbilical Cord

Keywords

Perinatal, Handwashing, Neonatal, Morbidity, Mortality, Primiparous, Health behavior, Developing countries, Sepsis, Omphalitis, Infectious disease, 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.

Interventions

BEHAVIORALPerinatal 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.

BEHAVIORALNeonatal 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.

Sponsors

State University of New York at Buffalo
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.1 month post-natal
Daily reduction in household soap weight.2 weeks post-natal.

Secondary

MeasureTime frame
Incidence density of suspected sepsis in neonates1 month post natal
Incidence density of suspected omphalitis in neonates1 month post-natal
All cause neonatal mortality rate.1 month post-natal.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026