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$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
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnant Women focused on measuring Low-birth-weight, Model kitchen, Improved cookstove

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 2, 2016
    Last Updated
    February 10, 2022
    Sponsor
    International Centre for Diarrhoeal Disease Research, Bangladesh
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    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

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    $100Kitchen and Low-birth-weight Study in Rural Bangladesh

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