Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period

NCT01955317 | Completed DMC

• 1 other identifier: PR-13023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

1. 1.Burden:
2. 2.Knowledge gap:
3. 3.Relevance:
4. 4.To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention on hand cleansing of mothers during the neonatal period The secondary objectives
5. 5.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
6. 6.To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal period among mothers, other family members, and birth attendants
7. 7.Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times.
8. 8.Observed hand cleansing behavior of other household members and visitors to home with chlorhexidine or soap and water at critical times.

Conditions

Hand Washing Behavior; Hand Cleansing Behavior; Chlorhexidine; Neonatal Period

Keywords

Neonate; Bangladesh; Health behavior; Handwashing; Developing countries; Infectious disease

Outcome Measures

Primary Outcomes (1)

• Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times

  We will observe hand cleansing behavior of mother through 3 hours structured observations.

  1 week and one month after birth

Secondary Outcomes (1)

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

  1 week and one month after birth

Study Arms (2)

chlorhexidine intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Hand cleansing with chlorhexidine BEHAVIORAL

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.

chlorhexidine intervention

Mother and neonatal health counselling BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• Plans to move out of study area between enrollment and 1 month after birth.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• State University of New York at Buffalo: collaborator

Study Sites (1)

Mirzapur

Tāngāil, Dhaka Division, Bangladesh

Location

MeSH Terms

Conditions

Health Behavior; Communicable Diseases

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Behavior; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: October 7, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 1, 2017

Record last verified: 2016-08

Locations

BA (1)