{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T06:07:48Z","timestamp":1788761268885,"version":"build-2803163510"},"reference-count":55,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pregnancy"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Preterm birth remains a leading cause of neonatal morbidity and mortality, yet clinicians possess limited tools to identify at\u2010risk pregnancies and implement effective interventions. This study evaluated whether knowledge of a mid\u2010second\u2010trimester maternal blood biomarker test result, combined with an intervention bundle for those identified as being at higher risk, improves neonatal outcomes in a population at low overall risk for spontaneous preterm birth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      PRIME was a multicenter, randomized, controlled trial at 19 US sites. Participants with singleton pregnancies at 18\u201320\n                      <jats:sup>6\/7<\/jats:sup>\n                      weeks\u2019 gestation underwent biomarker testing with the previously validated insulin\u2010like growth factor\u2010binding protein 4 to sex hormone\u2010binding globulin (IGFBP4\/SHBG) ratio and were randomized to an open\u2010label screen\u2010guided care arm or a blinded routine care arm. Higher\u2010risk participants in the screen\u2010guided care arm received a bundled intervention consisting of daily vaginal progesterone, low\u2010dose aspirin, and weekly telephonic nurse support. The co\u2010primary outcomes, analyzed in an intent\u2010to\u2010treat population, were: (1) a composite index of neonatal morbidity and mortality and (2) neonatal hospital length of stay. Additional outcomes were gestational age at birth, neonatal intensive care unit (NICU) admissions, and NICU length of stay. Outcomes were adjusted for parity, pre\u2010enrollment aspirin use, and COVID positivity. Recruitment was halted for efficacy at the interim analysis, and all enrolled participants were followed to delivery and neonatal outcome assessment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The enrolled population included 5018 participants with delivery data available for 4806, comprising the intent\u2010to\u2010treat population (2416 screen\u2010guided care, 2390 routine care). Screen\u2010guided care was associated with reduced composite neonatal morbidity (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.66\u20130.96;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.015), shortened neonatal hospital stays (incidence rate ratio [IRR], 0.95; 95% CI, 0.92\u20130.98;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.004), and fewer NICU admissions.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In low\u2010risk pregnancies, care guided by a maternal IGFBP4\/SHBG blood test with targeted interventions improved neonatal outcomes. These findings suggest a potential role for IGFBP4\/SHBG screen\u2010guided care in enhancing early risk detection and informing strategies to reduce events related to preterm birth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov identifier: NCT04301518<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pmf2.70202","type":"journal-article","created":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T06:21:07Z","timestamp":1767766867000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Neonatal impact of maternal biomarker screening for risk of preterm birth with targeted interventions (PRIME): A multicenter, randomized, controlled 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