SepsisNCT01309321
Perinatal Handwashing Intervention in Bangladesh
A study testing Perinatal Handwashing Promotion and Neonatal Health Promotion in people with Sepsis and Umbilical Cord, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Sepsis, Umbilical Cord, Infection
- What is being tested?
- Perinatal Handwashing Promotion and Neonatal Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBangladesh
- Study dates
- Oct 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primiparous women who plan to remain in the study area up to 1 months after birth
Who cannot join
- Prior live birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior
The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.
Read the detailed description
In high neonatal mortality settings, about half of neonatal deaths are estimated to occur because of infectious syndromes such as sepsis, acute respiratory infection, neonatal tetanus, and diarrhea. Promoting handwashing to mothers in the post-neonatal period has been shown to reduce the risk of pneumonia and diarrhea among infants > 28 days old but there is little information on the protective effect of handwashing for neonatal health outcomes. The proposed study will assess motivators and barriers to handwashing with soap among new mothers, and develop and test a hand cleansing promotion intervention in rural Bangladesh. The handwashing behavior change intervention will include approaches to enhance maternal expectations of being a good nurturer, as well as enhancing maternal self-efficacy to carry out handwashing behavior.
- Conditions
- Sepsis, Umbilical Cord, Infection
- Being tested
- Perinatal Handwashing Promotion, Neonatal Health Promotion
- Keywords
- Perinatal, Handwashing, Neonatal, Morbidity, Mortality, Primiparous, Health behavior, Developing countries, Sepsis, Omphalitis, Infectious disease, Bangladesh
- Medical subject headings
- Sepsis, Infections, Health Behavior, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal Handwashing PromotionBehavioural
Pregnancy may serve as a unique opportunity to improve maternal handwashing behavior more deeply and sustainably than a handwashing promotion intervention at a different time. Primiparous women will receive an intensive handwashing promotion program delivered at 3 in-home visits between one month prenatal and 1 week post natal. The program will promote handwashing benefits, provide hardware to reduce barriers to handwashing, and educate mothers about the critical times for handwashing. Mothers will also receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.
Neonatal Health PromotionBehavioural
Mothers will receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.
| Study group | Role | What they receive |
|---|---|---|
| Perinatal Handwashing Intervention Arm | Experimental | Not described Receives: Behavioral: Perinatal Handwashing Promotion |
| Neonatal Health Promotion | Active comparator | Not described Receives: Behavioral: Neonatal Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Measured: 1 month post-natal
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Measured: 3 months post-natal
Daily reduction in household soap weight.
Measured: 2 weeks post-natal.
Daily reduction in household soap weight.
Measured: 1 month post-natal
Secondary outcomes (3)
Incidence density of suspected sepsis in neonates
Measured: 1 month post natal
Incidence density of suspected omphalitis in neonates
Measured: 1 month post-natal
All cause neonatal mortality rate.
Measured: 1 month post-natal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York at Buffalo, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Sharifa Nasreen, MBBS, MPH, Principal investigator, International Centre for Diarrhoeal Disease Research, BangladeshPavani K. Ram, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309321
- Sponsor's protocol ID
- PR-10036
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2010
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior
- ClinicalTrials.gov ID
- NCT01309321
- Acronym / sponsor ID
- PR-10036
- Conditions
- Sepsis, Umbilical Cord, Infection
- Keywords
- Perinatal, Handwashing, Neonatal, Morbidity, Mortality, Primiparous, Health behavior, Developing countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- State University of New York at Buffalo, Centers for Disease Control and Prevention
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.
Detailed description
In high neonatal mortality settings, about half of neonatal deaths are estimated to occur because of infectious syndromes such as sepsis, acute respiratory infection, neonatal tetanus, and diarrhea. Promoting handwashing to mothers in the post-neonatal period has been shown to reduce the risk of pneumonia and diarrhea among infants > 28 days old but there is little information on the protective effect of handwashing for neonatal health outcomes. The proposed study will assess motivators and barriers to handwashing with soap among new mothers, and develop and test a hand cleansing promotion intervention in rural Bangladesh. The handwashing behavior change intervention will include approaches to enhance maternal expectations of being a good nurturer, as well as enhancing maternal self-efficacy to carry out handwashing behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perinatal Handwashing Intervention Arm | Experimental | Behavioral: Perinatal Handwashing Promotion |
| Neonatal Health Promotion | Active comparator | Behavioral: Neonatal Health Promotion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primiparous women who plan to remain in the study area up to 1 months after birth
Key exclusion criteria (1 listed)
- Prior live birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perinatal Handwashing PromotionPregnancy may serve as a unique opportunity to improve maternal handwashing behavior more deeply and sustainably than a handwashing promotion intervention at a different time. Primiparous women will receive an intensive handwashing promotion program delivered at 3 in-home visits between one month prenatal and 1 week post natal. The program will promote handwashing benefits, provide hardware to reduce barriers to handwashing, and educate mothers about the critical times for handwashing. Mothers will also receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs. | Behavioural | Perinatal Handwashing Intervention Arm |
| Neonatal Health PromotionMothers will receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs. | Behavioural | Neonatal Health Promotion |
Primary outcome
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Time frame: 1 month post-natal
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.
Time frame: 3 months post-natal
Daily reduction in household soap weight.
Time frame: 2 weeks post-natal.
Daily reduction in household soap weight.
Time frame: 1 month post-natal
3 secondary outcomes
Incidence density of suspected sepsis in neonates
Time frame: 1 month post natal
Incidence density of suspected omphalitis in neonates
Time frame: 1 month post-natal
All cause neonatal mortality rate.
Time frame: 1 month post-natal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharifa Nasreen, MBBS, MPH principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
Pavani K. Ram, MD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal Handwashing Promotion and Neonatal Health Promotion in people with Sepsis and Umbilical Cord, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change. (time frame: 1 month post-natal). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.