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Open Access 01-12-2022 | Study protocol

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

Authors: Camille Raynes-Greenow, Ashraful Alam, Sk Masum Billah, Sajia Islam, Kingsley Agho, S. M. Rokonuzzaman, Jonathan Thornburg, Shams El Arifeen, Atique Iqbal Chowdhury, Michael J. Dibley, The Poriborton Trial Team

Published in: Trials | Issue 1/2022

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

Available only for authorised users

Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2013;380(9859):2224–60.CrossRef

Gakidou E, Afshin A, Abajobir AA, Abate KH, Abbafati C, Abbas KM, et al. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1345–422. https://doi.org/10.1016/S0140-6736(17)32366-8.CrossRef

WHO. Air quality guidelines global update 2005: particulate matter, ozone, nitrogen dioxide and sulfur dioxide: WHO; 2005.

Krishna B, Balakrishnan K, Siddiqui AR, Begum BA, Bachani D, Brauer M. Tackling the health burden of air pollution in South Asia. BMJ. 2017;359:j5209. https://doi.org/10.1136/bmj.j5209.CrossRefPubMed

Pope DP, Mishra V, Thompson L, Siddiqui AR, Rehfuess EA, Weber M, et al. Risk of low birth weight and stillbirth associated with indoor air pollution from solid fuel use in developing countries. Epidemiol Rev. 2010;32(1):70–81. https://doi.org/10.1093/epirev/mxq005.CrossRefPubMed

Bruce NG, Dherani MK, Das JK, et al. Control of household air pollution for child survival: estimates for intervention impacts. BMC Public Health. 2013;13(S8). https://doi.org/10.1186/1471-2458-13-S3-S8.

WHO. Indoor air pollution from solid fuels and risk of low birth weight and stillbirth: report from a symposium held at the Annual Conference of the International Society for Environmental Epidemiology (ISEE), September 2005. Johannesburg: World Health Organization; 2007.

Tielsch JM, Katz J, Thulasiraj RD, Coles CL, Sheeladevi S, Yanik EL, et al. Exposure to indoor biomass fuel and tobacco smoke and risk of adverse reproductive outcomes, mortality, respiratory morbidity and growth among newborn infants in south India. Int J Epidemiol. 2009;38(5):1351–63. https://doi.org/10.1093/ije/dyp286.CrossRefPubMed

Amegah AK, Quansah R, Jaakkola JJK. Household air pollution from solid fuel use and risk of adverse pregnancy outcomes: a systematic review and meta-analysis of the empirical evidence. PLoS One. 2014;9(12):e113920. https://doi.org/10.1371/journal.pone.0113920.CrossRefPubMedPubMedCentral

10.

Mavalankar DV, Trivedi CR, Gray RH. Levels and risk factors for perinatal mortality in Ahmedabad, India. Bull World Health Organ. 1991;69(4):435–42.PubMedPubMedCentral

11.

Mishra V, Retherford RD, Smith KR. Cooking smoke and tobacco smoke as risk factors for stillbirth. Int J Environ Health Res. 2005;15(6):397–410. https://doi.org/10.1080/09603120500288913.CrossRefPubMed

12.

Siddiqui A, Gold E, Brown K, Lee K, Bhutta Z. Preliminary analyses of indoor air pollution and low birth weight (LBW) in Southern Pakistan. In: Indoor air pollution from solid fuels and risk of low birth weight and stillbirth Report from a symposium held at the Annual Conference of the International Society for Environmental Epidemiology (ISEE): 2005; Johannesburg, South Africa, vol. 2005; 2005. p. 11–4.

13.

Lawn JE, Blencowe H, Waiswa P, Amouzou A, Mathers C, Hogan D, et al. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet. 2016;387(10018):587–603. https://doi.org/10.1016/S0140-6736(15)00837-5.CrossRefPubMed

14.

Hug L, Alexander M, You D, Alkema L. National, regional, and global levels and trends in neonatal mortality between 1990 and 2017, with scenario-based projections to 2030: a systematic analysis. Lancet Glob Health. 2019;7(6):e710–20. https://doi.org/10.1016/S2214-109X(19)30163-9.CrossRefPubMedPubMedCentral

15.

Cousens S, Blencowe H, Stanton C, Chou D, Ahmed S, Steinhardt L, et al. National, regional, and worldwide estimates of stillbirth rates in 2009 with trends since 1995: a systematic analysis. Lancet. 2011;377(9774):1319–30. https://doi.org/10.1016/S0140-6736(10)62310-0.CrossRefPubMed

16.

Ellis M, Azad K, Banerjee B, Shaha SK, Prost A, Rego AR, et al. Intrapartum-related stillbirths and neonatal deaths in rural Bangladesh: a prospective, community-based cohort study. Pediatrics. 2011;127(5):e1182–90. https://doi.org/10.1542/peds.2010-0842.CrossRefPubMed

17.

Bangladesh Government. Bangladesh Country Action Plan (CAP) for scaling clean cooking solutions. In. Dhaka: Ministry of Power Division; 2013.

18.

Raynes-Greenow CH, Dibley MJ, El-Arifeen S, Alam A, Agho K, Huda T, et al. The impact of household air pollution on perinatal mortality; results from a large embedded cohort study in a rural setting in Bangladesh. In: Conference Proceedings, Society of Pediatric and Perinatal Epidemiology Annual Meeting (June 2016). Miami; 2016.

19.

National Institute of Population Research and Training (NIPORT) MaA, and ICF International. Bangladesh demographic and health survey 2014. Dhaka, Bangladesh, and Rockville, Maryland, USA: NIPORT, Mitra and Associates, and ICF International; 2016.

20.

Gurley ES, Salje H, Homaira N, Ram PK, Haque R, Petri Jr WA, Bresee J, Moss WJ, Luby SP, Breysse P, Azziz-Baumgartner E: Seasonal concentrations and determinants of indoor particulate matter in a low-income community in Dhaka, Bangladesh. Environ Res 2013, 121(0):11-16, https://doi.org/10.1016/j.envres.2012.10.004.

21.

Khan MN, CZ BN, Mofizul Islam M, Islam MR, Rahman MM. Household air pollution from cooking and risk of adverse health and birth outcomes in Bangladesh: a nationwide population-based study. Environ Health. 2017;16(1):57. https://doi.org/10.1186/s12940-017-0272-y.CrossRefPubMedPubMedCentral

22.

Nisha MK, Alam A, Raynes-Greenow C. Variations in perinatal mortality associated with different polluting fuel types and kitchen location in Bangladesh. Int J Occup Environ Health. 2018;24(1-2):47–54. https://doi.org/10.1080/10773525.2018.1507868.CrossRefPubMedPubMedCentral

23.

Haider MR, Rahman MM, Islam F, Khan MM. Association of low birthweight and indoor air pollution: biomass fuel use in Bangladesh. J Health Pollut. 2016;6(11):18–25. https://doi.org/10.5696/2156-9614-6-11.18.CrossRefPubMedPubMedCentral

24.

Amegah AK, Jaakkola JJK. Household air pollution and the sustainable development goals. Bull World Health Organ. 2016;94(3):215–21. https://doi.org/10.2471/BLT.15.155812.CrossRefPubMedPubMedCentral

25.

Blencowe H, Calvert PC, Lawn JE, Cousens S, Campbell OMR. Measuring maternal, foetal and neonatal mortality: challenges and solutions. Best Pract Res Clin Obstet Gynaecol. 2016;36:14–29. https://doi.org/10.1016/j.bpobgyn.2016.05.006.CrossRefPubMed

26.

Billah SM, Islam S, Tasnim F, Alam AN, El Arifeen S, Raynes-Greenow CH. Self-adopted ‘natural users’ of liquid petroleum gas for household cooking by women in pregnancy in rural Bangladesh: characteristics of high use and opportunities for intervention. Environ Res Lett. 2020, in press. https://doi.org/10.1088/1748-9326/ab7b25.

27.

Bangladesh bureau of statistics (bbs), statistics and informatics division (sid), ministry of planning gotpsro, Bangladesh: Population and housing census 2011. 2012.

28.

Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011;8(1):15–20. https://doi.org/10.3390/ijerph8010015.CrossRefPubMed

29.

StataCorp. Stata Statistical Software: release 15. College Station: StataCorp LLC. In; 2017.

30.

Raynes-Greenow C, Islam S, Khan J, Tasnim F, Nisha MK, Thornburg J, et al. Alam, Ashraful: A feasibility study assessing acceptability and supply issues of distributing LPG cookstoves and gas cylinders to pregnant women living in rural Bangladesh for Poriborton: the CHANge trial. Int J Environ Res Public Health. 2020;17(3):848. https://doi.org/10.3390/ijerph17030848.CrossRefPubMedCentral

31.

Thornburg J, Islam S, Billah SM, Chan B, McCombs M, Abbott M, et al. Pregnant women’s exposure to household air pollution in rural Bangladesh: a feasibility study for Poriborton: the CHANge trial. Int J Environ Res Public Health. 2022;19(1):482. https://doi.org/10.3390/ijerph19010482.CrossRefPubMedPubMedCentral

32.

Steenland K, Pillarisetti A, Kirby M, Peel J, Clark M, Checkley W. Howard H Chang, Clasen T: Modeling the potential health benefits of lower household air pollution after a hypothetical liquified petroleum gas (LPG) cookstove intervention. Environ Int. 2017;111:71–9. https://doi.org/10.1016/j.envint.2017.11.018.CrossRefPubMedPubMedCentral

33.

World Health Organization. International statistical classification of diseases and related health problems - 10th revision, vol. 2, 2010 edn. Geneva: World Health Organization; 2011.

34.

Lawless P, Rodes C, Ensor D. Multiwavelength absorbance of filter deposits for determination of environmental tobacco smoke and black carbon. Atmos Environ. 2004;38(21):3373–83. https://doi.org/10.1016/j.atmosenv.2004.03.038.CrossRef

35.

Lawless P, Thornburg J, Rodes C, Williams R. Personal exposure monitoring wearing protocol compliance: an initial assessment of quantitative measurement. J Exposure Sci Environ Epidemiol. 2012;22(3):274–80.

36.

Alam A, Tawale N, Patel A, Dibley MJ, Jadhao S, Raynes-Greenow C. Household air pollution intervention implications: findings from qualitative studies and a field trial of clean cookstoves in two rural villages in India. Int J Environ Res Public Health. 2016;13(9):893. https://doi.org/10.3390/ijerph13090893.

37.

Patel AB, Meleth S, Pasha O, Goudar SS, Esamai F, Garces AL, et al. Impact of exposure to cooking fuels on stillbirths, perinatal, very early and late neonatal mortality-a multicenter prospective cohort study in rural communities in India, Pakistan, Kenya, Zambia and Guatemala. Matern Health Neonatol Perinatol. 2015;1(1):18.CrossRefPubMedPubMedCentral

38.

Huda TM, Rahman MM, Raihana S, Islam S, Tahsina T, Alam A, et al. A community-based cluster randomised controlled trial in rural Bangladesh to evaluate the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality: the Shonjibon trial. BMC Public Health. 2018;18(1):816. https://doi.org/10.1186/s12889-018-5713-1.CrossRefPubMedPubMedCentral

39.

Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011;12(1):151. https://doi.org/10.1186/1745-6215-12-151.CrossRefPubMedPubMedCentral

40.

Murray DM. Design and analysis of group-randomized trials, vol. 29. USA: Oxford University Press; 1998.

41.

Chartier R, Phillips M, Mosquin P, Elledge M, Bronstein K, Nandasena S, et al. A comparative study of human exposures to household air pollution from commonly used cookstoves in Sri Lanka. Indoor Air. 2016:n/a-n/a.

42.

Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13–22. https://doi.org/10.1093/biomet/73.1.13.CrossRef

43.

West KP, Shamim AA, Mehra S, Labrique AB, Ali H, Shaikh S, et al. Effect of maternal multiple micronutrient vs iron–folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh: the JiVitA-3 randomized trial. JAMA. 2014;312(24):2649–58. https://doi.org/10.1001/jama.2014.16819.CrossRefPubMed

44.

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 Explanation and Elaboration: guidance for protocols of clinical trials. BMJ. 2013(346):200–7. https://doi.org/10.1136/bmj.e7586.

45.

70% households to get LPG in 3 years [http://www.dhakatribune.com/bangladesh/2016/10/27/70-households-get-lpg-3-years/]

46.

Taheruzzaman M, Janik P. Electric energy access in Bangladesh. Trans Environ Electrical Eng. 2016;1(2). https://doi.org/10.22149/teee.v1i2.13.

Title: 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
Authors: Camille Raynes-Greenow
Ashraful Alam
Sk Masum Billah
Sajia Islam
Kingsley Agho
S. M. Rokonuzzaman
Jonathan Thornburg
Shams El Arifeen
Atique Iqbal Chowdhury
Michael J. Dibley
The Poriborton Trial Team
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06146-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Hypothesis

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Hypothesis

Methods

Discussion

Trial registration

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