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

The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license. This version posted September 29, 2021. 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 and institutional support from St. Louis Children's Hospital, Barnes-Jewish Hospital, and Washington University in St. Louis School of Medicine. The authors have declared no competing interest. Data Availability: The data that support the findings of this cohort study are available from Washington University in St Louis. Restrictions apply to the availability of these data. Data are available from the authors with the permission of Washington University. Clinical Trial: This was a cohort study and not a clinical trial. This work was supported by a grant from the March of Dimes Foundation and institutional support from St. Louis's Children Hospital, Barnes Jewish Hospital, and Washington University in St. Louis School of Medicine. Author Declarations: I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes. The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study received ethical approval from the Washington University in St. Louis Institutional Review Board. All participants provided written informed consent for collection and use of clinical, biospecimen, imaging, or questionnaire data (IRB# 201612070). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes. I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes. I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes.

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