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Completed

NCT Number: NCT01309321

Perinatal Handwashing Intervention in Bangladesh

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.

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Key information

Conditions

Sepsis Behavior Communicable Diseases Disease Attributes Health Behavior Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Umbilical Cord

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ICDDR,B

Matlab, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior live birth

Treatment and study plan

Perinatal Handwashing Promotion

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

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.

Primary outcomes

  1. Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

    Time frame: 1 month post-natal

  2. Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.

    Time frame: 3 months post-natal

  3. Daily reduction in household soap weight.

    Time frame: 2 weeks post-natal.

  4. Daily reduction in household soap weight.

    Time frame: 1 month post-natal

Secondary outcomes

  1. Incidence density of suspected sepsis in neonates

    Time frame: 1 month post natal

  2. Incidence density of suspected omphalitis in neonates

    Time frame: 1 month post-natal

  3. All cause neonatal mortality rate.

    Time frame: 1 month post-natal.

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Collaborators

  • Centers for Disease Control and Prevention
  • State University of New York at Buffalo

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2011
Registry last updated
Mar 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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