Perinatal Handwashing Intervention in Bangladesh

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309321
• Other study ID #: PR-10036
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: March 12, 2014
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2010
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Sepsis
• Umbilical Cord

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	ICDDR,B	Matlab

Sponsors (3)

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

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.		1 month post-natal	No
Primary	Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.		3 months post-natal	No
Primary	Daily reduction in household soap weight.		2 weeks post-natal.	No
Primary	Daily reduction in household soap weight.		1 month post-natal	No
Secondary	Incidence density of suspected sepsis in neonates		1 month post natal	No
Secondary	Incidence density of suspected omphalitis in neonates		1 month post-natal	No
Secondary	All cause neonatal mortality rate.		1 month post-natal.	No