Perinatal Handwashing Intervention in Bangladesh

This study has been completed.
Sponsor:
Collaborators:
State University of New York at Buffalo
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01309321
First received: October 7, 2010
Last updated: March 12, 2014
Last verified: October 2010
  Purpose

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.


Condition Intervention
Sepsis
Umbilical Cord
Infection
Behavioral: Perinatal Handwashing Promotion
Behavioral: Neonatal Health Promotion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change. [ Time Frame: 1 month post-natal ] [ Designated as safety issue: No ]
  • Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change. [ Time Frame: 3 months post-natal ] [ Designated as safety issue: No ]
  • Daily reduction in household soap weight. [ Time Frame: 2 weeks post-natal. ] [ Designated as safety issue: No ]
  • Daily reduction in household soap weight. [ Time Frame: 1 month post-natal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence density of suspected sepsis in neonates [ Time Frame: 1 month post natal ] [ Designated as safety issue: No ]
  • Incidence density of suspected omphalitis in neonates [ Time Frame: 1 month post-natal ] [ Designated as safety issue: No ]
  • All cause neonatal mortality rate. [ Time Frame: 1 month post-natal. ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior live birth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309321

Locations
Bangladesh
ICDDR,B
Matlab, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
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
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01309321     History of Changes
Other Study ID Numbers: PR-10036
Study First Received: October 7, 2010
Last Updated: March 12, 2014
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Perinatal
Handwashing
Neonatal
Morbidity
Mortality
Primiparous
Health behavior
Developing countries
Sepsis
Omphalitis
Infectious disease
Bangladesh

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014