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Community Level Intervention for Pre-Eclampsia (CLIP) Trial: An International Cluster Randomized Trial: Challenges in Design, Implementation and Analysis
The CLIP trial was a cluster randomized trial conducted in 4 lower to middle income countries, India, Pakistan, Nigeria and Mozambique. Pre-eclampsia remains a leading cause of maternal and perinatal mortality and morbidity. The hypothesis was that implementing community-level evidence-based care would reduce pre-eclampsia-related maternal and perinatal mortality and major morbidity by 20% by addressing ‘three delays’ in triage, transport, and treatment. Each country was to have a large enough sample size to serve as an independent trial, and the plan was to use individual patient data (IPD) meta analysis to determine if there was an effect on maternal mortality and morbidity across countries. The focus of this talk will be on the major challenges faced by such a project in terms of design, implementation and analysis.
C2E2 Rounds are presented Mondays from 12:00 pm to 1:00 pm in room 700 of the VGH Research Pavilion, 828 West 10th Avenue, Vancouver, BC.