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Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01955317
First Posted: October 7, 2013
Last Update Posted: September 1, 2017
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.
Collaborator:
State University of New York at Buffalo
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
  Purpose

Background (brief):

  1. Burden:

    Neonatal death still unacceptably high in low income countries. The common causes of neonatal death are pneumonia, sepsis and omphalitis. Many neonatal infections occur because the mother's hands or the hands of the person who attended the birth are unclean. Our previous study found that there was substantial concern about excessive exposure of the mother or the neonate to water during handwashing because of the perception that frequent contact with water could lead to respiratory illness.

  2. Knowledge gap:

    Chlorhexidine has been evaluated for use in hand hygiene applications in high-income countries, particularly in healthcare, but it has not been evaluated or promoted for hand cleansing at the household level in low- and middle-income countries.

  3. Relevance:

A waterless hand cleanser employing chlorhexidine would overcome important barriers to handwashing with soap, perceptions of cold resulting from exposure to water, and the time limitations perceived by mothers.

Hypothesis: Mothers who are exposed to a chlorhexidine-based hand cleansing intervention will clean their hands (with chlorhexidine or soap and water) more frequently than mothers who are not exposed to the chlorhexidine-based hand cleansing program.

Objectives:

The primary objective

  1. To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention on hand cleansing of mothers during the neonatal period The secondary objectives
  2. To demonstrate the impact of chlorhexidine-based hand hygiene intervention on hand cleansing of other family members, visitors to the neonate, and birth attendants during the neonatal period
  3. To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal period among mothers, other family members, and birth attendants

Methods:

We propose a randomized controlled trial in a rural area of Bangladesh, with an active control. Randomization will be at the level of the participating pregnant woman. Each arm will include 150 participants. All intervention visits will follow baseline data collection. A trained health and hygiene promoter will carry out two visits in the antenatal period and one postnatal visit to deliver intervention messages.

Outcome measures:

  1. Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times.
  2. Observed hand cleansing behavior of other household members and visitors to home with chlorhexidine or soap and water at critical times.

Condition Intervention
Hand Washing Behavior Hand Cleansing Behavior Chlorhexidine Neonatal Period Behavioral: Hand cleansing with chlorhexidine Behavioral: Mother and neonatal health counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times [ Time Frame: 1 week and one month after birth ]
    We will observe hand cleansing behavior of mother through 3 hours structured observations.


Secondary Outcome Measures:
  • Observed hand cleansing behavior of other household members and visitors to home with chlorhexidine or soap and water at critical times [ Time Frame: 1 week and one month after birth ]
    We will observe hand cleansing behavior at critical time of other household members through 3 hours structured observations.


Enrollment: 300
Actual Study Start Date: October 2013
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chlorhexidine intervention
The intervention arm will also receive hand hygiene counselling with chlorhexidine and a pump bottle with chlorhexidine lotion along with mothers and neonatal health counseling.
Behavioral: Hand cleansing with chlorhexidine
Pregnant women in the intervention arm will receive an intensive hand cleansing promotion delivered at 3 in-home visits between one month prenatal and 1 week post natal. The intervention will promote and discuss with mothers the benefits of hand cleansing with chlorhexidine before breastfeeding, before umbilical cord care, after contact with respiratory secretions, and the convenience of using a waterless hand sanitizer especially during the neonatal period. Each mother will receive a half-liter pump bottle with chlorhexidine lotion. The program will also educate mothers about infectious causes of morbidity and mortality in neonates and promote understanding of the risk to the neonate from these diseases.
Active Comparator: Control
This arm will receive maternal and neonatal health counselling which includes discussion and education about antenatal care, safe and clean delivery, recognition of danger signs for the mother and neonate, immediate new born care, and essential new born care. Each mother will receive a clean delivery kit and pictoral cue cards for danger sign recognition.
Behavioral: Mother and neonatal health counselling
This arms will receive maternal and neonatal health counselling which includes discussion and education about antenatal care, safe and clean delivery, recognition of danger signs for the mother and neonate, immediate new born care, and essential new born care. Each mother will receive a clean delivery kit and pictoral cue cards for danger sign recognition.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Pregnant women older than 18 years that are at 32-36 weeks gestation and intend to reside in the location which they are residing at the time of recruitment into the study through the remainder of the antenatal period and the first 4 weeks after birth.

Exclusion Criteria:

  • Plans to move out of study area between enrollment and 1 month after 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): NCT01955317


Locations
Bangladesh
Mirzapur
Tangail, Dhaka, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
State University of New York at Buffalo
  More Information

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01955317     History of Changes
Other Study ID Numbers: PR-13023
First Submitted: August 25, 2013
First Posted: October 7, 2013
Last Update Posted: September 1, 2017
Last Verified: August 2016

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Neonate
Bangladesh
Health behavior
Handwashing
Developing countries
Infectious disease

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents