Trial record 3 of 350 for:    excel

Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborator:
State University of New York at Buffalo
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01955317
First received: August 25, 2013
Last updated: June 24, 2014
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    We will observe hand cleansing behavior at critical time of other household members through 3 hours structured observations.


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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: NCT01955317

Contacts
Contact: Tania Bulbul, MD, MPH 0088028819419 ext 117 tbulbul@icddrb.org

Locations
Bangladesh
Mirzapur Recruiting
Tangail, Dhaka, Bangladesh
Contact: Tania Bulbul, MD, MPH    008801711664246    tbulbul@icddrb.org   
Principal Investigator: Tania Bulbul, MD, MPH         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
State University of New York at Buffalo
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01955317     History of Changes
Other Study ID Numbers: PR-13023
Study First Received: August 25, 2013
Last Updated: June 24, 2014
Health Authority: Bangladesh: Ethical Review Committee

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
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014