Hesham, Helai http://orcid.org/0000-0002-9802-6182
Orejuela, Francisco
Rood, Kara M.
Turrentine, Mark
Casey, Brian
Khandelwal, Meena
Dajao, Rori
Azad, Sarah
Rosen, Todd
Hoffman, Matthew K.
Wang, Eileen Y.
Hart, Laura
Sheen, Jean-Ju
Grisales, Tamara
Gibson, Kelly S.
Torbenson, Vanessa
Williams, Shauna F.
Evantash, Edward
Dietz, Hans P.
Wapner, Ronald J.
Article History
Received: 9 May 2024
Accepted: 30 June 2024
First Online: 3 August 2024
Declarations
:
: The anonymized datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
: These data have not been previously presented or published.
: Each of the 15 study sites operated under Institutional Review Board approval and oversight; these include: the IRB for Baylor College of Medicine and Affiliated Hospitals, Houston, TX, USA (H-45294); University of California-Los Angeles Office of the Human Research Protection Program (21–000156); El Camino Hospital Institutional Review Board, Mountain View, CA, USA (ECH 21–01); Columbia University Human Research Protection Office, New York, NY, USA (IRB-AAAT8894); Ohio State University/WIRB-Copernicus Group IRB (20213099); Cooper University Hospital, Camden, NJ/Columbia University Human Research Protection Office, New York, NY, USA (IRB-AAAT7698); MetroHealth IRB, Cleveland, OH, USA (MOD00000059); Rutgers New Jersey Medical School, Newark, NJ/Columbia University Human Research Protection Office, New York, NY, USA (IRB-AAAT7698); Robert Wood Johnson Medical School, Rutgers University, New Brunswick, NJ/Columbia University Human Research Protection Office, New York, NY, USA (IRB-AAAT7698); University of Alabama/WIRB-Copernicus Group IRB (20213099); Temple University Office of Research, Philadelphia, PA/Columbia University Human Research Protection Office, New York, NY, USA (IRB-AAAT7698); Christiana Care Health System, Newark, DE/Columbia University Human Research Protection Office, New York, NY, USA (IRB-AAAT7698); University of Pennsylvania/WIRB-Copernicus Group IRB (20213099); Mayo Clinic IRB, Rochester, MN, USA (21–009271); and Oregon Health & Science University Hospital/WIRB-Copernicus Group IRB (20213099).
: All authors are Study Investigators whose institutions received study support from Materna. H.H., F.O., K.M.R., M.T., R.D., S.A., M.K.H., L.H., V.T., S.F.W., and R.J.W. report no other potential conflicts of interest. B.C. reports institutional grant support for research from the National Heart, Lung, and Blood Institute (NHLBI), US National institutes of Health (NIH); and is an Obstetrics Editor for McGraw-Hill Companies (New York, NY, USA). M.K. reports institutional grant support for research from Siemens Healthcare Diagnostics (Washington, DC, USA), the US National Institute of Child Health and Human Development (NICHD), and . T.R. reports grant support from the NHLBI, the NICHD, the National Institute of Environmental Health Sciences. and ; and has received consulting fees from Organon & Co (Jersey City, NJ, USA). E.Y.W. reports research funding from Penn Health-Tech, University of Pennsylvania (Philadelphia, PA, USA). J.J.S. received compensation for professional writing from UpToDate Inc. (Alphen aan den Rijn, The Netherlands) and faculty honoraria from the Society for Maternal–Fetal Medicine (SMFM; Washington, DC, USA) and Banner University Medical Center (Phoenix, AZ, USA). T.G. received consulting fees from Hinge Health (San Francisco, CA, USA), and has interests in US Provisional Patent Application No. 62/924,376. K.S.G. reports research funding from the NHLBI, the NICHD, and the Ohio Department of Health; speaker fees from the University of Oklahoma; consulting fees from the NIH RADx program; travel support from SMFM and the Maternal–Fetal Medicine Unit to attend research meetings; and has unpaid leadership roles on EPIC Obstetrics Steering Boards and SMFM Committees and Board of Directors. E.E. received consulting and speakership fees from Materna Medical. H.P.D. reports receiving consulting fees and honoraria from GE Medical, Mindray Inc. (Shenzhen, China), and Materna Medical; payment for expert testimony from multiple sources; and equipment loans from GE Medical and Mindray.