A multidisciplinary Prematurity Research Cohort Study

Creators: Stout, Molly J.; Chubiz, Jessica; Raghuraman, Nandini; Zhao, Peinan; Tuuli, Methodius G.; Wang, Lihong V.; Cahill, Alison G.; Cuculich, Phillip S.; Wang, Yong; Jungheim, Emily S.; Herzog, Erik D.; Fay, Justin; Schwartz, Alan L.; Macones, George A.; England, Sarah K.

Abstract

Background: Worldwide, 10% of babies are born preterm, defined as a live birth before 37 weeks of gestation. Preterm birth is the leading cause of neonatal death, and survivors face lifelong risks of adverse outcomes. New approaches with large sample sizes are needed to identify strategies to predict and prevent preterm birth. The primary aims of the Washington University Prematurity Research Cohort Study were to conduct three prospective projects addressing possible causes of preterm birth and provide data and samples for future research. Study design: Pregnant patients were recruited into the cohort between January 2017 and January 2020. Consenting patients were enrolled into the study before 20 weeks' gestation and followed through delivery. Participants completed demographic and lifestyle surveys; provided maternal blood, placenta samples, and cord blood; and participated in up to three projects focused on underlying physiology of preterm birth: cervical imaging (Project 1), circadian rhythms (Project 2), and uterine magnetic resonance imaging and electromyometrial imaging (Project 3). Results: A total of 1260 participants were enrolled and delivered during the study period. Of the participants, 706 (56%) were Black/African American, 494 (39%) were nulliparous, and 185 (15%) had a previous preterm birth. Of the 1260 participants, 1220 (97%) delivered a live infant. Of the 1220 with a live birth, 163 (14.1%) had preterm birth, of which 74 (6.1%) were spontaneous preterm birth. Of the 1220 participants with a live birth, 841 participated in cervical imaging, 1047 contributed data and/or samples on circadian rhythms, and 39 underwent uterine magnetic resonance imaging. Of the 39, 25 underwent electromyometrial imaging. Conclusion: We demonstrate feasibility of recruiting and retaining a diverse cohort in a complex prospective, longitudinal study throughout pregnancy. The extensive clinical, imaging, survey, and biologic data obtained will be used to explore cervical, uterine, and endocrine physiology of preterm birth and can be used to develop novel approaches to predict and prevent preterm birth.

Additional Information

© 2022 Stout et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. We thank the Prematurity Research Cohort Study participants for their invaluable contributions to preterm birth research. We thank the research staff for their tireless efforts enrolling and following participants and collecting and managing data and specimens. We thank Deborah Frank, PhD, Stephanie Pizzella, Christine Kramer, and Jillian Ashley-Martin, PhD, for editorial comments and Anthony Bartley for graphical assistance. This work was supported by a research grant from the March of Dimes Foundation (to M.J. S, P.Z, M.G.T., L.V.W., A.G.C, Y.W., E.S.J., E.D.H., J.F, A.L.S., G.A.M. and S.K.E.). The cohort was make possible by support institutional support from St. Louis Children's Hospital, Barnes-Jewish Hospital, and Washington University School of Medicine. Data Availability: The data are not publicly available as the minimal data set for this study on pregnant participants contains identifying patient-level data which cannot be suitably de-identified or aggregated. Additionally, a subset of participants did not consent for future research in the patient consent form approved by the Institutional Review Board at Washington University in St. Louis. Proposals for access to this data should be directed to christinekramer@wustl.edu, Senior Clinical Research Coordinator in the Division of Clinical Research in the Department of Obstetrics and Gynecology. To gain access, data requestors will need to sign a data access agreement. The authors have declared that no competing interests exist.

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