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The Poriborton : Change trial: Household Air Pollution and Perinatal and early Neonatal mortality.

A cluster randomised controlled trial of LPG cookstoves and gas commenced in early pregnancy and continued throughout to reduce perinatal mortality. The Poriborton: Change Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001214224
Acronym
Poriborton: The Change Trial
Enrollment
4944
Registered
2018-07-19
Start date
2019-09-24
Completion date
2021-06-07
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Globally, household air pollution (HAP) is the 3rd leading health risk for mortality, and the most important global environmental health risk (1). The South Asian burden is acute, and it is their most considered health risk (1). The global mortality attributable to HAP is 4.3 million deaths or 7.7% of all deaths (1). Approximately, 3 billion people depend on biomass fuels (e.g. wood, dung, crop waste), and this combined with incomplete combustion using inefficient stoves, in poorly ventilated areas, over long hours of cooking and heating, causes the exposure with women and children bearing the greatest burden, and being particularly vulnerable (2, 3). The impact on pregnancy is unknown. The epidemiological evidence is suggestive of an association, however, there is a paucity of good quality prospective data (4). Perinatal mortality (defined as stillbirth less than 28 weeks and early neonatal death up to and equal to 7 days after birth) is recognized as a major global health disease burden. The global burden of Stillbirth is high with ~2.6 million stillbirths per year (5), and stillbirth estimates in Bangladesh are high at 35 per 1000, and are worse in rural areas (6,7), where there is universal reliance on polluting usual stoves (8,9). We propose to conduct a community based cluster randomized trial to explore the effectiveness and cost effectiveness of cleaner cooking (LPG and ICS) in preventing adverse perinatal outcomes. This trial is needed as it will address several important gaps of the impact of HAP and the impact on pregnancy outcomes. REFERENCES 1. Lim, S.S.etal., A comparative risk assessment of burden of disease …a systematic analysis for the Global Burden of Disease Study 2010.Lancet, 2012. 380(9859): p. 2224-60. 2. Fullerton, D.G.etal., Indoor air pollution from biomass fuel smoke is a major health concern in the developing world. Royal Society of Trop Med Hyg, 2008. 102(9): p. 843. 3. WHO, Indoor Air Poll from Solid Fuels and risk of low birth weight and stillbirth. 2005. 4. Tielsch, J.M.etal., Exposure to indoor biomass fuel and tobacco smoke and risk of adverse reproductive outcomes, International Journal of Epidemiology, 2009. 38(5): p. 1351-1363. 5. Rehfuess, E., Fuel for life - household energy and health.World Health Organization, 2006. 6.United Nations., The Millennium Development Goals Report. 2014: New York. 7. Lawn, J.E. Stillbirths: rates, risk factors, and accelerating towards 2030. Lancet, 2016. 387: 587. 8. UNICEF., Levels and Trends in Child Mortality. 2014, UNICEF. 9. Lawn, J.E.etal., 4 million neo… deaths:When? Where? Why? Lancet, 2005. 365(9462): 891.

Interventions

Liquid Petroleum Gas (LPG) two-burner stove and LPG fuel in cylinders will be delivered to participants soon after enrolment. This will include initial set-up and connection. Adoption of LPG cooking will be supported by behaviour change communication (BCC) from field staff who will visit participants homes monthly, for about an hour during pregnancy until the birth. LPG gas in cylinders will be replenished as needed to ensure continuous LPG supply until the birth. The BCC material will inc

Liquid Petroleum Gas (LPG) two-burner stove and LPG fuel in cylinders will be delivered to participants soon after enrolment. This will include initial set-up and connection. Adoption of LPG cooking will be supported by behaviour change communication (BCC) from field staff who will visit participants homes monthly, for about an hour during pregnancy until the birth. LPG gas in cylinders will be replenished as needed to ensure continuous LPG supply until the birth. The BCC material will include a pictorial leaflet, short video's shown to participants during the monthly visits on tablets, and verbal messages to help support adoption of LPG cooking, and tips for trouble shooting with LPG cooking (if any). This material is based on the formative research done for this trial. Field staff will be trained in delivering the BCC material at three time points throughout the intervention period to ensure consistency of the messages. Training will be a 2 day sessions conducted by senior research staff, who will teach the field staff how to deliver to the messages about continual gas use, and how to overcome LPG difficulties.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
15 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria for participants • All newly identified pregnant women aged 15 to 49 years • Gestational age is less than or equal to 20 weeks and are • Permanent residents of the study area. For the trial extension inclusion criteria: currently enrolled women with a live infant, < 90 days post-partum

Exclusion criteria

Exclusion criteria for participants • Woman could not recall last menstrual period (LMP) • Woman not a permanent resident of the study area Exclusion criteria for clusters • Cookstove interventions currently being implemented by either government or non-government agencies in the selected area • Area it is prone to flooding for extended periods, which would impede access by the research team

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026