{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T19:42:38Z","timestamp":1793562158071,"version":"4.5.0"},"reference-count":24,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,7,25]]},"abstract":"Importance<\/jats:title>A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting.<\/jats:p><\/jats:sec>Objective<\/jats:title>To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n\u2009=\u2009280) or usual care (n\u2009=\u2009264). Use of vaginal progesterone was at the discretion of treating clinicians.<\/jats:p><\/jats:sec>Main Outcome and Measures<\/jats:title>The primary outcome was delivery or fetal death prior to 37 weeks.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal\/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal\/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32).<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal\/infant mortality.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT02901626<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2023.10812","type":"journal-article","created":{"date-parts":[[2023,7,25]],"date-time":"2023-07-25T11:52:05Z","timestamp":1690285925000},"page":"340","source":"Crossref","is-referenced-by-count":56,"title":["Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix"],"prefix":"10.1001","volume":"330","author":[{"given":"Matthew K.","family":"Hoffman","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Columbia University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca G.","family":"Clifton","sequence":"additional","affiliation":[{"name":"George Washington University Biostatistics Center, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph R.","family":"Biggio","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George R.","family":"Saade","sequence":"additional","affiliation":[{"name":"University of Texas Medical Branch at Galveston, Galveston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynda G.","family":"Ugwu","sequence":"additional","affiliation":[{"name":"George Washington University Biostatistics Center, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Longo","sequence":"additional","affiliation":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine Z.","family":"Bousleiman","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Columbia University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Clark","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill, Chapel Hill"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William A.","family":"Grobman","sequence":"additional","affiliation":[{"name":"Northwestern University, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather A.","family":"Frey","sequence":"additional","affiliation":[{"name":"The Ohio State University, Columbus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suneet P.","family":"Chauhan","sequence":"additional","affiliation":[{"name":"University of Texas Health Science at Houston\u2013Children\u2019s Memorial Hermann Hospital, Houston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorraine","family":"Dugoff","sequence":"additional","affiliation":[{"name":"Hospital of the University of Pennsylvania, Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy A.","family":"Manuck","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill, Chapel Hill"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward K.","family":"Chien","sequence":"additional","affiliation":[{"name":"MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dwight J.","family":"Rouse","sequence":"additional","affiliation":[{"name":"Brown University, Providence, Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyagriv N.","family":"Simhan","sequence":"additional","affiliation":[{"name":"The University of Pittsburgh, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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