We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perinatal Handwashing Intervention in Bangladesh

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01309321
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : March 13, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Sepsis Umbilical Cord Infection Behavioral: Perinatal Handwashing Promotion Behavioral: Neonatal Health Promotion

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior
Study Start Date : October 2010
Primary Completion Date : July 2013
Study Completion Date : July 2013
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309321


Locations
Bangladesh
ICDDR,B
Matlab, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
State University of New York at Buffalo
Centers for Disease Control and Prevention
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

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01309321     History of Changes
Other Study ID Numbers: PR-10036
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: October 2010

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