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During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3\u00a0months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3\u00a0months.<\/jats:p>\n            <\/jats:sec><jats:sec>\n              <jats:title>Results<\/jats:title>\n              <jats:p>A total of 214 women were randomized to Device (<jats:italic>n<\/jats:italic>\u2009=\u2009113) or Control (<jats:italic>n<\/jats:italic>\u2009=\u2009101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3\u00a0months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (<jats:italic>p<\/jats:italic>\u2009=\u20090.040; two-tailed Fisher\u2019s test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related.<\/jats:p>\n            <\/jats:sec><jats:sec>\n              <jats:title>Conclusions<\/jats:title>\n              <jats:p>The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.<\/jats:p>\n            <\/jats:sec>","DOI":"10.1007\/s00192-024-05881-6","type":"journal-article","created":{"date-parts":[[2024,8,3]],"date-time":"2024-08-03T10:02:09Z","timestamp":1722679329000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9802-6182","authenticated-orcid":false,"given":"Helai","family":"Hesham","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco","family":"Orejuela","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kara M.","family":"Rood","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Turrentine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Casey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meena","family":"Khandelwal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rori","family":"Dajao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Azad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Todd","family":"Rosen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew K.","family":"Hoffman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eileen Y.","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Hart","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Ju","family":"Sheen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamara","family":"Grisales","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly S.","family":"Gibson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanessa","family":"Torbenson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shauna F.","family":"Williams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"Evantash","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans P.","family":"Dietz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald J.","family":"Wapner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,8,3]]},"reference":[{"key":"5881_CR1","doi-asserted-by":"publisher","first-page":"220","DOI":"10.1111\/ajo.12059","volume":"53","author":"HP Dietz","year":"2013","unstructured":"Dietz HP. 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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\u2013Fetal 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\u2013Fetal 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.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}}]}}