ABSTRACT
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. [ FROM AUTHOR] Copyright of Obstetrics & Gynecology is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)