Pregnant WomenPhase 2NCT02923882
$100Kitchen and Low-birth-weight Study in Rural Bangladesh
A Phase 2 study testing '$100Kitchen and improved cookstove' in people with Pregnant Women and Low-Birth-Weight Infant, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Pregnant Women, Low-Birth-Weight Infant
- What is being tested?
- '$100Kitchen and improved cookstove'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jun 2014
- Phase
- Phase 2
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women at 8 to 12 weeks gestational age
Who cannot join
- Pregnant women more than 12 weeks gestational age
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnant Women, Low-Birth-Weight Infant
- Being tested
- '$100Kitchen and improved cookstove'
- Keywords
- Low-birth-weight, Model kitchen, Improved cookstove
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'$100Kitchen and improved cookstove'Other
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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'. Receives: Other: '$100Kitchen and improved cookstove' |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of low-birth-weight (LBW) among newborns between intervention and control groups
Measured: Birth outcome was measured within 72 hours of the delivery
Secondary outcomes (1)
Differences of maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level between intervention and control groups
Measured: Maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level was measured during 2nd and 3rd trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923882
- Sponsor's protocol ID
- PR-12087
- Status last verified
- Mar 2013
- First submitted
- 2 Oct 2016
- Last updated
- 11 Feb 2022
- Results posted
- No
Publications
Ahmed A, Rahman AE, Ahmed S, Rahman F, Sujan HM, Ahmmed F, Hossain AT, Sayeed A, Hossain S, Huq NL, Quaiyum MA, Reichenbach L, El Arifeen S. Effect of low-cost kitchen with improved cookstove on birthweight of neonates in Shahjadpur, Bangladesh: a cluster-randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Jan 3;25:100342. doi: 10.1016/j.lansea.2023.100342. eCollection 2024 Jun.
PubMed 39021478
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple and Safe "100-dollar-kitchen" to Prevent Low-birth-weight in a Rural Area in Bangladesh: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02923882
- Acronym / sponsor ID
- PR-12087
- Conditions
- Pregnant Women, Low-Birth-Weight Infant
- Keywords
- Low-birth-weight, Model kitchen, Improved cookstove
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Oct 2016 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: '$100Kitchen and improved cookstove'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'. |
| Control group | No intervention | –In the control group, the pregnant women at 8-12 weeks of gestational age used biomass fuels for cooking in the traditional cookstove. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women at 8 to 12 weeks gestational age
Key exclusion criteria (1 listed)
- Pregnant women more than 12 weeks gestational age
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 |
|---|---|---|
| '$100Kitchen and improved cookstove' | Other | Intervention group |
Primary outcome
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
1 secondary outcome
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
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 11 Feb 2022.
- Derived from this study: PubMed 39021478Ahmed A, Rahman AE, Ahmed S, Rahman F, Sujan HM, Ahmmed F, Hossain AT, Sayeed A, Hossain S, Huq NL, Quaiyum MA, Reichenbach L, El Arifeen S. Effect of low-cost kitchen with improved cookstove on birthweight of neonates in Shahjadpur, Bangladesh: a cluster-randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Jan 3;25:100342. doi: 10.1016/j.lansea.2023.100342. eCollection 2024 Jun.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing '$100Kitchen and improved cookstove' in people with Pregnant Women and Low-Birth-Weight Infant, run by International Centre for Diarrhoeal Disease Research, 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 low-birth-weight (LBW) among newborns between intervention and control groups (time frame: Birth outcome was measured within 72 hours of the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923882, which also lists 1 linked publication.
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 11 Feb 2022.