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PREPARE: PROTOCOL FOR A STEPPED WEDGE TRIAL TO EVALUATE WHETHER A RISK STRATIFICATION MODEL CAN REDUCE PRETERM DELIVERIES AMONG WOMEN WITH SUSPECTED OR CONFIRMED PRETERM PRE-ECLAMPSIA
Author
Affilliation
Department of Global Health, Milken Institute of Public Health, George Washington University. Washington, District of Columbia. USA / Division of Vaccines and Immunization, Center for Global Health, Colorado School of Public Health. Aurora, Colorado, USA.
Department of Child and Adolescent Health, University of the West Indies. Kingston, Jamaica / Global Health Program, Cornwall Regional Hospital, West Virginia University School of Medicine. Jamaica.
General Health Council of Mexico. Mexico City, Mexico.
Center for Research, Diagnostic and Reference, Tropical Medicine Institute Pedro Kouri. Havana, Cuba.
Department of Medicine, University of California San Francisco. San Francisco, California.
Universidade Federal de Goiás. Instituto de Medicina Tropical e Higiene. Departamento de Saúde Coletiva. Goiânia, GO, Brasil.
Faculty of Medicine, Special Advisor to the Ministry of Health for COVID-19, University of the Andes. Santiago, Chile.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. WHO. MoH, Laboratório de Referência SARS COv2. Laboratório de Vírus Respiratório e do Sarampo. Rio de Janeiro, RJ, Brasil.
Pan American Health Organization. Washington, District of Columbia, USA.
American Society of Tropical Medicine and Hygiene. Arlington, Virginia, USA.
Department of Obstetrics and Gynecology. University of Pittsburgh. Pittsburgh, PA, USA.
Department of Child and Adolescent Health, University of the West Indies. Kingston, Jamaica / Global Health Program, Cornwall Regional Hospital, West Virginia University School of Medicine. Jamaica.
General Health Council of Mexico. Mexico City, Mexico.
Center for Research, Diagnostic and Reference, Tropical Medicine Institute Pedro Kouri. Havana, Cuba.
Department of Medicine, University of California San Francisco. San Francisco, California.
Universidade Federal de Goiás. Instituto de Medicina Tropical e Higiene. Departamento de Saúde Coletiva. Goiânia, GO, Brasil.
Faculty of Medicine, Special Advisor to the Ministry of Health for COVID-19, University of the Andes. Santiago, Chile.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. WHO. MoH, Laboratório de Referência SARS COv2. Laboratório de Vírus Respiratório e do Sarampo. Rio de Janeiro, RJ, Brasil.
Pan American Health Organization. Washington, District of Columbia, USA.
American Society of Tropical Medicine and Hygiene. Arlington, Virginia, USA.
Department of Obstetrics and Gynecology. University of Pittsburgh. Pittsburgh, PA, USA.
Abstract
Background: Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. Methods: This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. Discussion: The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries.
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