{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T07:02:27Z","timestamp":1791874947185,"version":"4.3.4"},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,4,10]],"date-time":"2018-04-10T00:00:00Z","timestamp":1523318400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Pennsylvania Chapter of the March of Dimes"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ultrasound in Obstet &amp;amp; Gyne"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine if pessary use prevents preterm birth (PTB) in women with singleton pregnancy, with short cervical length (CL) measured on transvaginal sonography (TVS) and without prior spontaneous PTB (sPTB).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was an open\u2010label multicenter randomized trial of asymptomatic women presenting at 18\u2009+\u20090 to 23\u2009+\u20096\u2009weeks' gestation with a singleton pregnancy, CL\u2009\u2264\u200925\u2009mm on TVS and no prior sPTB. sPTB included those with spontaneous onset of labor and those with rupture of membranes prior to labor. Subjects were randomized to receive either a Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal\u2013fetal medicine staff. Vaginal progesterone was recommended to women with CL\u2009\u2264\u200920\u2009mm. The primary outcome was PTB\u2009&lt;\u200937\u2009weeks. A sample size of 121 women in each group (<jats:italic>n<\/jats:italic>\u2009=\u2009242) was needed to detect a reduction in the primary outcome from 30% in the no\u2010pessary group to 15% in the pessary group. The trial was stopped early before complete enrollment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between 17 March 2014 and 29 July 2016, 17\u2009383 women underwent CL measurement on TVS. Of these, 422 (2.4%) had CL\u2009\u2264\u200925\u2009mm and 391 (92.7%) met the full eligibility criteria, of which 122 (31.2%) agreed to randomization. Sixty\u2010one (50%) women were randomized to the pessary group and 61 (50%) to the no\u2010pessary group. Baseline characteristics were similar between the groups. There were no significant differences between the pessary and no\u2010pessary groups in the rate of PTB\u2009&lt;\u200937\u2009weeks (43% <jats:italic>vs<\/jats:italic> 40%; relative risk 1.09; 95% CI, 0.71\u20131.68) or in secondary outcomes, such as rate of PTB\u2009&lt;\u200934\u2009weeks, rate of PTB\u2009&lt;\u200928\u2009weeks, gestational age at delivery, birth weight and rate of composite adverse neonatal outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Cervical pessary use was not associated with prevention of PTB in women with a singleton pregnancy, short CL on TVS and no prior sPTB in this small, underpowered randomized controlled trial. Copyright \u00a9 2017 ISUOG. Published by John Wiley &amp; Sons Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/uog.18908","type":"journal-article","created":{"date-parts":[[2017,9,20]],"date-time":"2017-09-20T12:54:45Z","timestamp":1505912085000},"page":"573-579","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":58,"title":["Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial"],"prefix":"10.1002","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8192-0113","authenticated-orcid":false,"given":"L.","family":"Dugoff","sequence":"first","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Perelman School of Medicine at the University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2854-0239","authenticated-orcid":false,"given":"V.","family":"Berghella","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Sidney Kimmel Medical College of Thomas Jefferson University  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Sehdev","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Perelman School of Medicine at the University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. D.","family":"Mackeen","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Women's Health Service Line Geisinger Health System  Danville PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Goetzl","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Temple University  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Ludmir","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Sidney Kimmel Medical College of Thomas Jefferson University  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,4,10]]},"reference":[{"key":"e_1_2_6_2_1","volume-title":"Births: preliminary data for 2015. 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