Perinatal Handwashing Intervention in Bangladesh

NCT ID: NCT01309321

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-07-31

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.

Conditions

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Sepsis Umbilical Cord Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Perinatal Handwashing Intervention Arm

Group Type EXPERIMENTAL

Perinatal Handwashing Promotion

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Neonatal Health Promotion

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharifa Nasreen, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Pavani K. Ram, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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ICDDR,B

Matlab, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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PR-10036

Identifier Type: -

Identifier Source: org_study_id

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