$100Kitchen and Low-birth-weight Study in Rural Bangladesh
Primary Purpose
Pregnant Women, Low-Birth-Weight Infant
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
'$100Kitchen and improved cookstove'
Sponsored by
About this trial
This is an interventional prevention trial for Pregnant Women focused on measuring Low-birth-weight, Model kitchen, Improved cookstove
Eligibility Criteria
Inclusion Criteria:
- Pregnant women at 8 to 12 weeks gestational age
Exclusion Criteria:
- Pregnant women more than 12 weeks gestational age
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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'.
In the control group, the pregnant women at 8-12 weeks of gestational age used biomass fuels for cooking in the traditional cookstove.
Outcomes
Primary Outcome Measures
Proportion of low-birth-weight (LBW) among newborns between intervention and control groups
Secondary Outcome Measures
Differences of maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level between intervention and control groups
Full Information
NCT ID
NCT02923882
First Posted
October 2, 2016
Last Updated
February 10, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT02923882
Brief Title
$100Kitchen and Low-birth-weight Study in Rural Bangladesh
Official Title
Simple and Safe "100-dollar-kitchen" to Prevent Low-birth-weight in a Rural Area in Bangladesh: A Cluster Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women, Low-Birth-Weight Infant
Keywords
Low-birth-weight, Model kitchen, Improved cookstove
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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'.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In the control group, the pregnant women at 8-12 weeks of gestational age used biomass fuels for cooking in the traditional cookstove.
Intervention Type
Other
Intervention Name(s)
'$100Kitchen and improved cookstove'
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women at 8 to 12 weeks gestational age
Exclusion Criteria:
Pregnant women more than 12 weeks gestational age
12. IPD Sharing Statement
Learn more about this trial
$100Kitchen and Low-birth-weight Study in Rural Bangladesh
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