{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T20:10:27Z","timestamp":1774296627201,"version":"3.50.1"},"reference-count":59,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T00:00:00Z","timestamp":1771977600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","award":["R01HD083292"],"award-info":[{"award-number":["R01HD083292"]}]},{"DOI":"10.13039\/100000063","name":"Office of Dietary Supplements","doi-asserted-by":"crossref","award":["R01HD083292-03S1"],"award-info":[{"award-number":["R01HD083292-03S1"]}],"id":[{"id":"10.13039\/100000063","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Predisposition to Develop Preeclampsia Trial","award":["NIH #RO1 HL071944"],"award-info":[{"award-number":["NIH #RO1 HL071944"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Preterm birth (PTB) at &lt;33 wks\u2019 gestation annually accounts for more than 60,000 births in the United States and 2 million births worldwide. Of these, spontaneous PTB (sPTB) at &lt;33 wks\u2019 gestation complicates about 1.8% of US births, while early onset preeclampsia (EOP), necessitating delivery at \u226433 wks\u2019 gestation, complicates an additional 0.8% of US births. Current screening is based on medical and pregnancy history and biophysical variables with the goal of sensitizing patients and caregivers to early symptom identification. There is no individual patient risk prediction for sPTB at \u226433 wks\u2019 gestation. We now have preventative therapies for women at high risk for EOP with delivery at &lt;33 wks\u2019 gestation (aspirin) and sPTB at \u226433 wks\u2019 gestation (+\/\u2212 preterm premature rupture of membranes (PPROMs)) (docosahexaenoic acid (DHA). Both require initiation of therapy by ~16 wks\u2019 gestation for optimal effect, a requirement that current screening options cannot satisfy except for the FMF Combined Test for EOP. Neither do we have either an effective first-trimester screen for sPTB nor a dual screen for both of these major obstetric disorders. FutureBIRTH\u00ae is a maternal five-plasma RNA panel supported by multiple external validation studies to provide effective dual screening for sPTB at &lt;33 wks\u2019 gestation and EOP with delivery at \u226433 wks\u2019 gestation. Herein, we present the second external validation study for EOP with delivery at \u226433 wks with maternal sampling 12\u201313 wks 6 d combined with a review of the potential clinical impact of FutureBIRTH\u00ae on the prevention of sPTB and EOP. Methods: Two NIH cohorts totaling 494 women were sampled from 12 to 20 wks. FutureBIRTH\u00ae marker expression was quantified by polymerase chain reaction (PCR) as in the four preceding external validation studies. Results: After appropriate exclusions, there were nine cases (2.4%) of EOP with delivery at \u226433 wks gestation and 370 controls. Of this cohort, 79 (21%) were sampled at &lt;14 wks\u2019 gestation. Two of the nine cases were sampled at &lt;14 wks\u2019 gestation. NAMPT expression at 12\u201320 wks\u2019 gestation was significantly increased in women destined for EOP with delivery at \u226433 wks\u2019 gestation. Only the addition of diastolic blood pressure improved the predictive accuracy of NAMPT, yielding an AUC of 0.89 with a DR of 89% (8\/9). Two cases sampled at &lt;14 wks\u2019 gestation who developed EOP with delivery at \u226433 wks\u2019 gestation were screen positive, and two subjects placed on aspirin before 14 wks\u2019 gestation were screen false positives. Conclusions: FutureBIRTH\u00ae offers dual screening for EOP and sPTB with a sampling window extending down to 12 wks\u2019 gestation, thus enabling the widespread use of preventative therapy.<\/jats:p>","DOI":"10.3390\/diagnostics16050660","type":"journal-article","created":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T12:35:17Z","timestamp":1772022917000},"page":"660","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Plasma RNA-Based Dual Screening for Early\/Extreme Spontaneous Preterm Birth and Early Onset Preeclampsia to Enable Prevention"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1044-9026","authenticated-orcid":false,"given":"Carl P.","family":"Weiner","sequence":"first","affiliation":[{"name":"School of Medicine, Creighton University, Phoenix, AZ 85012, USA"},{"name":"College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3579-1685","authenticated-orcid":false,"given":"Susan E.","family":"Carlson","sequence":"additional","affiliation":[{"name":"University of Kansas Medical Center, University of Kansas, Kansas City, KS 66160, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2272-5139","authenticated-orcid":false,"given":"Hamutal","family":"Meiri","sequence":"additional","affiliation":[{"name":"TeleMarpe Ltd., Tel Aviv 6908742, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"73.e1","DOI":"10.1016\/j.ajog.2016.09.097","article-title":"Explaining the recent decrease in US infant mortality rate, 2007\u20132013","volume":"216","author":"Callaghan","year":"2017","journal-title":"Am. 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