- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923882
$100Kitchen and Low-birth-weight Study in Rural Bangladesh
February 10, 2022 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh
Simple and Safe "100-dollar-kitchen" to Prevent Low-birth-weight in a Rural Area in Bangladesh: A Cluster Randomized Controlled Trial
Low-birth-weight (LBW) is a major adverse pregnancy outcome in resource-poor countries.
About 28% of all neonatal deaths worldwide are directly attributed to LBW.
Exposure to biomass fuel during cooking is associated with LBW.
There is unlikely to be any significant change in the use of biomass fuels in the near future, therefore, interventions targeted to reduce the harmful effects on poor pregnancy outcomes is warranted.
To address this need, the investigators proposed a locally-made inexpensive prefabricated model of the "100-dollar-kitchen"($100Kitchen) with an improved cookstove for resource-poor settings.
The improved cookstove of the $100Kitchen ensure complete incineration of the biomass fuels and thus, provided safeguard to the pregnant women using these fuels.
This study has been measured the impact of our '$100Kitchen and improved cookstove' intervention as to whether a pregnant woman residing in a household with a '$100Kitchen and improved cookstove' is less likely to give birth to a LBW newborn.
A cluster-randomized controlled trial has been adopted in Shahjadpur sub-district in Bangladesh and 628 and 639 pregnant women at 8-12 weeks gestational age enrolled for each intervention and control area respectively and followed-up through 42-days post-delivery.
Birth outcomes have been noted and the newborns have been weighted within 72-hrs of the delivery.
Non-invasive maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level between the intervention and control groups have also been measured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A single-stage cluster sampling was followed.
All the 'mouzas' (revenue villages) in Shahjadpur sub-district were divided into clusters so that each cluster contained a population of about 3,000.
This generated 188 clusters.
104 out of 188 clusters-52 clusters for the intervention and 52 clusters for the control group - were randomly selected for the study to enroll the required 1300 pregnant women.
Each cluster was then randomly allocated to either the intervention or control group using a computer generated random sequence.
The random allocation sequence was generated independently by a statistician, who had no further involvement with the study.
Once allocated, in each cluster all the eligible pregnant women were identified, invited, and enrolled during door-to-door visits by the project field staff.
The field staff included female health workers, with the help of existing government community health workers such as family welfare assistants.
A total of 628 eligible pregnant women were enrolled in the intervention clusters and a total of 639 eligible pregnant women in the control clusters.
During the enrolment in the intervention clusters, a $100Kitchen with the improved cookstoves was installed at each of the 628 pregnant women's households following the verbal and written consent of the women and the household head.
Study Type
Interventional
Enrollment (Actual)
1300
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 49 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant women at 8 to 12 weeks gestational age
Exclusion Criteria:
- Pregnant women more than 12 weeks gestational age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
In the intervention group, the pregnant women at 8-12 weeks of gestational age used biomass fuels for cooking in the '$100Kitchen and improved cookstove'.
|
|
No Intervention: Control group
In the control group, the pregnant women at 8-12 weeks of gestational age used biomass fuels for cooking in the traditional cookstove.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of low-birth-weight (LBW) among newborns between intervention and control groups
Time Frame: Birth outcome was measured within 72 hours of the delivery
|
Birth outcome was measured within 72 hours of the delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences of maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level between intervention and control groups
Time Frame: Maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level was measured during 2nd and 3rd trimester of pregnancy
|
Maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level was measured during 2nd and 3rd trimester of pregnancy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
October 2, 2016
First Submitted That Met QC Criteria
October 4, 2016
First Posted (Estimate)
October 5, 2016
Study Record Updates
Last Update Posted (Actual)
February 11, 2022
Last Update Submitted That Met QC Criteria
February 10, 2022
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-12087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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