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

NCT02923882 | Completed Phase 2

• 1 other identifier: PR-12087
• Study Type: interventional
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnant Women; Low-Birth-Weight Infant

Keywords

Low-birth-weight; Model kitchen; Improved cookstove

Outcome Measures

Primary Outcomes (1)

• Proportion of low-birth-weight (LBW) among newborns between intervention and control groups

  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

  Maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level was measured during 2nd and 3rd trimester of pregnancy

Study Arms (2)

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'.

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.

Interventions

'$100Kitchen and improved cookstove' OTHER

Intervention group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women at 8 to 12 weeks gestational age

You may not qualify if:

• Pregnant women more than 12 weeks gestational age

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Related Publications (1)

• 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.

  PMID: 39021478 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2016
• First Posted: October 5, 2016
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 11, 2022

Record last verified: 2013-03