Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01955317 |
| Other study ID # |
PR-13023 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
August 25, 2013 |
| Last updated |
August 31, 2017 |
| Start date |
October 2013 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
August 2016 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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
- Maternal and neonatal health counseling
- Hand hygiene promotion (described in "Intervention" section) Randomization will be
at the level of the participating pregnant woman (i.e. individual-level
randomization). We will use a block randomization strategy to randomize
participants to either the intervention or active control 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:
- Highlight the vulnerability of the neonatal period
- Inform participant and her family of the schedule recommended by the Government of
Bangladesh for prenatal care and strongly encourage participants to seek appropriate
prenatal care, including Tetanus Toxoid vaccination. Tetanus toxoid is provided free of
cost as part of antenatal care at all Government of Bangladesh health facilities.
- Discuss birth plans and encourage participants to develop a birth plan, including
location of the birth, materials, persons needed and an emergency plan.
- Introduce and discuss the use of a clean delivery kit for hygienic delivery to reduce
infections. This will include instructions on cutting the umbilical cord. Provide a
clean delivery kit to the participant, which will include a clean blade, clean string
for tying the cord, clean mat for the mother to lie on, among other items.
- Encourage close family members to motivate or demand hand washing with soap by birth
attendants before and during labor and delivery.
- Discuss maternal danger signs with participant and her family and encourage care seeking
when recognized
- Discuss neonatal danger signs with participant and her family and encourage care seeking
when recognized
- Discuss neonatal hypothermia prevention with participant and her family and work with
the family to build acceptance of the message
- Discuss the benefit of immediate and exclusive breastfeeding with participant and her
family and work with the family to build acceptance of the message
- Provide chlorhexidine and gauze, and explain chlorhexidine cord care to the participant
and work with her and her family.
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:
- Present hand cleansing as an opportunity for the mother to protect the health of her
child, and to improve perception of herself as a good mother
- Remind of the vulnerability of the newborn period, and suggest that the use of
chlorhexidine for hand cleansing makes loving hands to be protective hands
- Encourage maternal self-efficacy for protecting the health of the baby
- Identify motivators and barriers to hand cleansing among mothers and other people that
care for the baby
- Identify critical times for hand cleansing with chlorhexidine
- Increase individual and social (family/compound) expectations for hand cleansing among
mothers and other caregivers
- Guide family to create solution for barriers to hand cleansing
- Introduce chlorhexidine as a product to help protect the baby's health, demonstrate use
and discuss who, when and how to use it.
- Discuss demanding or motivating use of chlorhexidine by other family members, visitors
and the birth attendant
- Set up a visual cue card, and a calendar with visual reminders in the home as references
and cues for hand cleansing at specific critical times
- Discuss creating a habit of hand cleansing, what that concretely means and how to do so
Critical times for hand cleansing:
- For mothers and secondary caregivers:
- Before umbilical cord care
- After contact with respiratory secretions
- At three fixed times of day: morning, after lunch, and evening: given the residual
antimicrobial effect of chlorhexidine, hand cleansing at these fixed times will result
in hands being protected from contamination for much of the day.
- For visitors to the household and for children:
- Before touching the neonate
- After contact with respiratory secretions or contact with nasal or oral mucosa
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:
1. Observe hand cleansing, either by use of chlorhexidine or by handwashing with water +
soap, during 3-hour structured observations
2. Measure residual sanitizer weight and volume as markers of chlorhexidine consumption
Structured observations involve the placement of a study staff member in the
participant's home / household compound for an extended period of time in order to
observe typical behaviors. In this study the observations will be conducted in both
intervention and treatment arms by female field staff who will sit in a suitable place
to observe the mothers without getting in the way of their normal care giving activities
of the neonates. We are interested in observing the following behaviors during
structured observations (Appendix 6).
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:
- Acceptability of chlorhexidine
- Reported use of chlorhexidine versus handwashing hardware
- Behavioral determinants of hand hygiene We will collect qualitative data from a subset
of mothers in the intervention arm to understand in-depth about barriers and motivators
to chlorhexidine use for hand cleansing at the conclusion of all quantitative data
collection.
