INTRODUCTION:This study sought to determine whether a decentralized, mobile-friendly, virtual model could achieve appropriate enrollment for a pregnancy health study after COVID-19 closed most clinical research. Preterm birth continues to be a significant and growing issue with 2021 rates exceeding 10%. There is urgent need for new research and technology to improve the ability to predict, prevent, and personalize treatment for complications such as preterm birth, preeclampsia, and gestational diabetes.METHODS:This was a prospective, observational study of a cell-free RNA platform utilizing direct-to-participant recruitment via targeted social media from July 2020 to December 2021. The IRB-approved study was open to patients aged 18–45 with a singleton pregnancy in the United States. Participants signed informed consent, provided record release forms, completed a short questionnaire, and scheduled mobile phlebotomy via a web-based platform.RESULTS:One thousand eight hundred ninety-four participants submitted samples in less than 18 months. Because of delays in shipping, insufficient volume, temperature stability, and hemolysis, 63 samples (3.3%) were not useable. Medical records were received for over 85% of participants. The cohort is geographically and ethnically diverse representing 1,220 zip codes across 30 states.CONCLUSION:This work demonstrates a decentralized, mobile-friendly, virtual study is feasible, efficient, scalable, and flexible, enabling clinical research during a global pandemic. The rate of medical records receipt is likely affected by the large quantity of unique providers and hospitals. This is a rapid, patient-accepted way to conduct clinical research as a supplement to traditional enrollment models.
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