Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period
Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period
Background (brief):
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.
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.
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
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:
Neonates (babies < 28 days old) die at unacceptably high rates (26deaths per 1000 live births) in many resource-limited countries, accounting for about 40% of deaths among all children under 5 years old. Infections such as pneumonia, sepsis, and omphalitis are common causes of neonatal death. Many neonatal infections occur because the mother's hands or the hands of the person who attended the birth are unclean. In Nepal, newborns who survived were significantly more likely than newborns who died to have mothers reporting handwashing, and birth attendants who were reported to wash hands before the delivery. But, mothers and birth attendants often do not wash their hands, despite the vulnerability of the neonatal period.
The traditional approach to improving handwashing among caregivers of young children is to teach about critical times to wash hands and how to wash hands. This narrow, prescriptive approach ignores the barriers to hand hygiene unique to the Perinatal and neonatal periods. Moreover, our qualitative findings suggest that frequent handwashing with water may not be acceptable. That is, both mothers and birth attendants reported that, when mothers come into contact with water frequently (e.g. by washing hands often), the newborn child is at risk of developing upper and lower respiratory infection. A novel technological solution - one that provides efficiency and portability and obviates the need for washing with water - may overcome important obstacles to improving hand cleansing behavior in the neonatal period.
During the discrete time frame of the neonatal period, chlorhexidine for hand cleansing represents a focused intervention with substantial potential for scalability. The shelf-life of chlorhexidine is long (2-3 years), facilitating its scaling up and efficient distribution, for example, in clean delivery kits that are provided to low-income mothers throughout resource-limited countries.
Given the potential for this low-technology solution to break through critical barriers to handwashing with water and soap, and markedly reduce neonatal mortality, we propose to conduct a randomized controlled trial to evaluate the impact of a chlorhexidine-based hand cleansing intervention on maternal, familial, and birth attendant hand cleansing behavior in the peripartum and neonatal periods.
Methods Study design
We propose a randomized controlled trial in a rural area of Bangladesh, with an active control. The two treatment arms are:
Active control arm Maternal and neonatal health counseling (described in "Intervention" section)
Intervention arm
The intervention:
All intervention visits will follow baseline data collection. A trained health and hygiene promoter will carry out two visits in the antenatal period (at 34-35 weeks and at 36-38 weeks) and one postnatal visit (1-3 days after delivery) to deliver intervention messages.
Maternal and neonatal health counseling:
Study participants in both intervention and control arms will receive maternal and neonatal health counseling. The objectives of the maternal and neonatal health counseling are to:
Materials: Each participant will be given a clean delivery kit and a culturally appropriate pictorial card depicting each of the danger signs for the mother pre-, during, and post-labor, and for the neonate.
Description of behavioral communication approach: Interactions with the health and hygiene promoter will be in the form of a discussion where the health/hygiene promoter will facilitate discussions and provide explanation and guidance as needed.
Hand hygiene counseling:
Objectives of hand hygiene counseling:
Critical times for hand cleansing:
Timing of intervention visits:
Respondents randomized to the intervention arm will receive one hand hygiene promotion during the second visit (at 36-38 weeks of gestation) prior to the review of the maternal and neonatal health counseling.
Chlorhexidine for hand cleansing: We are positioning chlorhexidine as a product that is of unique importance in the neonatal period, and may have substantive bactericidal and bacteriostatic effects, making it superior to soap for hand cleansing, particularly in the vulnerable newborn period.
Data collection Identification of pregnant women and selection criteria: The proposed study will be conducted in 4 unions in Mirzapur that are already under demographic surveillance. Pregnant women are routinely identified as part of the demographic surveillance.
Obtaining informed consent and baseline data collection: A data collector will describe the study to the pregnant woman at 32-34 weeks gestation and seek informed consent from her for participation. The data collector will also request informed consent from the head of household for interview of secondary caregivers regarding practices during the labor and delivery process, and two structured observations of hand cleansing behavior among all household members.
Randomization and initiation of intervention: We will use a block randomization strategy, using blocks of 4, to randomize participants to either the intervention or active control arm. Block randomization is also referred to as "restricted randomization" and allows for the numbers in the intervention arm to be roughly similar to those in the control arm throughout the enrolment period.
Objectives 1 and 2: Hand cleansing behavior measurement
To compare treatment arms with respect to mothers' hand cleansing behavior in the neonatal period (Objective 1), we will do the following:
Hand cleansing at critical times (either by chlorhexidine use or by washing hands with soap and water; handwashing with soap will be considered the corollary to chlorhexidine use since the control arm does not have access to chlorhexidine) Objective 3: Acceptability of chlorhexidine In both groups, we will record participant- or household member-initiated reporting of any skin reactions, other possible adverse events, and acceptability of the chlorhexidine with respect to ease of use, scent, skin comfort and the occurrence of skin reactions (Objective 3).
At approximately day 28 of the neonate's life, we will conduct an end line survey (Appendix 7) with the mother, during which we will assess the following in a quantitative manner in the intervention group:
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: