RÉSUMÉ
Background: Household air pollution (HAP) is a leading environmental risk factor accounting for about 1.6â million premature deaths mainly in low- and middle-income countries (LMICs). However, no multicounty randomized controlled trials have assessed the effect of liquefied petroleum gas (LPG) stove intervention on HAP and maternal and child health outcomes. The Household Air Pollution Intervention Network (HAPIN) was the first to assess this by implementing a common protocol in four LMICs. Objective: This manuscript describes the implementation of the HAPIN data management protocol via Research Electronic Data Capture (REDCap) used to collect over 50â million data points in more than 4000 variables from 80 case report forms (CRFs). Methods: We recruited 800 pregnant women in each study country (Guatemala, India, Peru, and Rwanda) who used biomass fuels in their households. Households were randomly assigned to receive LPG stoves and 18â months of free LPG supply (intervention) or to continue using biomass fuels (control). Households were followed for 18â months and assessed for primary health outcomes: low birth weight, severe pneumonia, and stunting. The HAPIN Data Management Core (DMC) implemented identical REDCap projects for each study site using shared variable names and timelines in local languages. Field staff collected data offline using tablets on the REDCap Mobile Application. Results: Utilizing the REDCap application allowed the HAPIN DMC to collect and store data securely, access data (near real-time), create reports, perform quality control, update questionnaires, and provide timely feedback to local data management teams. Additional REDCap functionalities (e.g. scheduling, data validation, and barcode scanning) supported the study. Conclusions: While the HAPIN trial experienced some challenges, REDCap effectively met HAPIN study goals, including quality data collection and timely reporting and analysis on this important global health trial, and supported more than 40 peer-reviewed scientific publications to date.
RÉSUMÉ
BACKGROUND: Approximately 3 to 4 billion people worldwide are exposed to household air pollution, which has been associated with increased blood pressure (BP) in pregnant women in some studies. METHODS: We recruited 3195 pregnant women in Guatemala, India, Peru, and Rwanda and randomly assigned them to intervention or control groups. The intervention group received a gas stove and fuel during pregnancy, while the controls continued cooking with solid fuels. We measured BP and personal exposure to PM2.5, black carbon and carbon monoxide 3× during gestation. We conducted an intention-to-treat and exposure-response analysis to determine if household air pollution exposure was associated with increased gestational BP. RESULTS: Median 24-hour PM2.5 dropped from 84 to 24 µg/m3 after the intervention; black carbon and carbon monoxide decreased similarly. Intention-to-treat analyses showed an increase in systolic BP and diastolic BP in both arms during gestation, as expected, but the increase was greater in intervention group for both systolic BP (0.69 mm Hg [0.03-1.35]; P=0.04) and diastolic BP (0.62 mm Hg [0.05-1.19]; P=0.03). The exposure-response analyses suggested that higher exposures to household air pollution were associated with moderately higher systolic BP and diastolic BP; however, none of these associations reached conventional statistical significance. CONCLUSIONS: In intention-to-treat, we found higher gestational BP in the intervention group compared with controls, contrary to expected. In exposure-response analyses, we found a slight increase in BP with higher exposure, but it was not statistically significant. Overall, an intervention with gas stoves did not markedly affect gestational BP.