Protocol for a cluster randomised controlled trial of LPG cookstoves compared to usual cooking practices to reduce perinatal mortality and morbidity in rural Bangladesh called Poriborton: the CHANge trial.

ABSTRACT

BACKGROUND: Household air pollution is a leading health risk for global morbidity and mortality and a major health risk in South Asia. However, there are no prospective investigations of the impact of household air pollution on perinatal morbidity and mortality. Our trial aims to assess the impact of liquefied petroleum gas (LPG) for cooking to reduce household air pollution exposure on perinatal morbidity and mortality compared to usual cooking practices in Bangladesh. HYPOTHESIS: In a community-based cluster randomised controlled trial of pregnant women cooking with LPG throughout pregnancy, perinatal mortality will be reduced by 35% compared with usual cooking practices in a rural community in Bangladesh. METHODS: A two-arm community-based cluster randomised controlled trial will be conducted in the Sherpur district, Bangladesh. In the intervention arm, pregnant women receive an LPG cookstove and LPG in cylinders supplied throughout pregnancy until birth. In the control or usual practice arm, pregnant women continue their usual cooking practices, predominately traditional stoves with biomass fuel. Eligible women are pregnant women with a gestational age of 40-120 days, aged between 15 and 49 years, and permanent residents of the study area. The primary outcome is the difference in perinatal mortality between the LPG arm and the usual cooking arm. Secondary outcomes include (i) preterm birth and low birth weight, (ii) personal level exposure to household air pollution, (iii) satisfaction and acceptability of the LPG stove and stove use, and (iv) cost-effectiveness and cost-utility in reducing perinatal morbidity and mortality. We follow up all women and infants to 45 days after the birth. Personal exposure to household air pollution is assessed at three-time points in a sub-sample of the study population using the MicroPEM™. The total required sample size is 4944 pregnant women. DISCUSSION: This trial will produce evidence of the effectiveness of reduced exposure to household air pollution through LPG cooking to reduce perinatal morbidity and mortality compared to usual cooking practices. This evidence will inform policies for the adoption of clean fuel in Bangladesh and other similar settings. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12618001214224 . Prospectively registered on 19 July 2019.