Helai Hesham, Francisco Orejuela, Kara M. Rood, Mark Turrentine, Brian Casey, Meena Khandelwal, Rori Dajao, Sarah Azad, Todd Rosen, Matthew K. Hoffman, Eileen Y. Wang, Laura Hart, Jean-Ju Sheen, Tamara Grisales, Kelly S. Gibson, Vanessa Torbenson, Shauna F. Williams, Edward Evantash, Hans P. Dietz, Ronald J. Wapner
{"title":"产前骨盆扩张器对初产妇阴道分娩时提肛肌撕脱的影响:随机对照试验","authors":"Helai Hesham, Francisco Orejuela, Kara M. Rood, Mark Turrentine, Brian Casey, Meena Khandelwal, Rori Dajao, Sarah Azad, Todd Rosen, Matthew K. Hoffman, Eileen Y. Wang, Laura Hart, Jean-Ju Sheen, Tamara Grisales, Kelly S. Gibson, Vanessa Torbenson, Shauna F. Williams, Edward Evantash, Hans P. Dietz, Ronald J. Wapner","doi":"10.1007/s00192-024-05881-6","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction and Hypothesis</h3><p>The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. 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 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>A total of 214 women were randomized to Device (<i>n</i> = 113) or Control (<i>n</i> = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 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 (<i>p</i> = 0.040; two-tailed Fisher’s test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><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. 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Wapner\",\"doi\":\"10.1007/s00192-024-05881-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Introduction and Hypothesis</h3><p>The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery.</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. 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 months. Three urogynecologists performed blinded interpretation of ultrasound images. 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Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial
Introduction and Hypothesis
The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery.
Methods
A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. 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 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months.
Results
A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 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 (p = 0.040; two-tailed Fisher’s test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related.
Conclusions
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.
期刊介绍:
The International Urogynecology Journal is the official journal of the International Urogynecological Association (IUGA).The International Urogynecology Journal has evolved in response to a perceived need amongst the clinicians, scientists, and researchers active in the field of urogynecology and pelvic floor disorders. Gynecologists, urologists, physiotherapists, nurses and basic scientists require regular means of communication within this field of pelvic floor dysfunction to express new ideas and research, and to review clinical practice in the diagnosis and treatment of women with disorders of the pelvic floor. This Journal has adopted the peer review process for all original contributions and will maintain high standards with regard to the research published therein. The clinical approach to urogynecology and pelvic floor disorders will be emphasized with each issue containing clinically relevant material that will be immediately applicable for clinical medicine. This publication covers all aspects of the field in an interdisciplinary fashion