Francisco J Orejuela1, Rajshi Gandhi2, Lauren Mack2, Wesley Lee2, Haleh Sangi-Haghpeykar2, Hans P Dietz3, Susan M Ramin2. 1. Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA. orejuela@bcm.edu. 2. Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA. 3. Department of Obstetrics and Gynecology, Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
Abstract
INTRODUCTION AND HYPOTHESIS: The objective was to assess the safety and feasibility of using a pelvic floor dilator during active labor to prevent injuries to the levator ani muscle (LAM) and perineum. METHODS: In a prospective pilot study, a pelvic floor dilator using soft pads was introduced into the vaginal canal to gradually expand the vagina, in 30 nulliparous women and in 10 controls. The primary outcomes were adverse events related to the device. Secondary outcomes were perineal lacerations after delivery, sonographically defined levator ani injury, hiatal area dimensions, and anal sphincter disruption, all at 12-20 weeks postpartum, and maximum pelvic floor dilation, time to achieve maximum dilation, and device retention rate. RESULTS: From October 2014 through November 2016, a total of 494 women were screened, and 61 consented to the study. Thirty women used the device and 27 returned for follow-up. No maternal or neonatal injuries were related to use of the dilator. The average maximum dilation of the vaginal canal was 7.4 cm (SD 0.7, range 5.5-8.0). Dilation time averaged 27 min (SD 13, range 5-60). Device insertion adjustment was needed in 13 out of 30 cases (43%). Similar rates of 3th-4th degree perineal lacerations were seen in both groups. Levator ani avulsion was diagnosed in 2 out of 27 (7%) in the device group and in 1 out of 9 (11%) in the control group (p = 0.2). The rate of partial injury in the device group was 2 out of 27 (7%) vs 2 out of 9 (22%) in the comparison group (p = 0.2). CONCLUSION: The use of the pelvic floor dilator during active labor is feasible. No safety issues were identified.
INTRODUCTION AND HYPOTHESIS: The objective was to assess the safety and feasibility of using a pelvic floor dilator during active labor to prevent injuries to the levator ani muscle (LAM) and perineum. METHODS: In a prospective pilot study, a pelvic floor dilator using soft pads was introduced into the vaginal canal to gradually expand the vagina, in 30 nulliparous women and in 10 controls. The primary outcomes were adverse events related to the device. Secondary outcomes were perineal lacerations after delivery, sonographically defined levator aniinjury, hiatal area dimensions, and anal sphincter disruption, all at 12-20 weeks postpartum, and maximum pelvic floor dilation, time to achieve maximum dilation, and device retention rate. RESULTS: From October 2014 through November 2016, a total of 494 women were screened, and 61 consented to the study. Thirty women used the device and 27 returned for follow-up. No maternal or neonatal injuries were related to use of the dilator. The average maximum dilation of the vaginal canal was 7.4 cm (SD 0.7, range 5.5-8.0). Dilation time averaged 27 min (SD 13, range 5-60). Device insertion adjustment was needed in 13 out of 30 cases (43%). Similar rates of 3th-4th degree perineal lacerations were seen in both groups. Levator ani avulsion was diagnosed in 2 out of 27 (7%) in the device group and in 1 out of 9 (11%) in the control group (p = 0.2). The rate of partial injury in the device group was 2 out of 27 (7%) vs 2 out of 9 (22%) in the comparison group (p = 0.2). CONCLUSION: The use of the pelvic floor dilator during active labor is feasible. No safety issues were identified.
Authors: Jennifer M Wu; Catherine A Matthews; Mitchell M Conover; Virginia Pate; Michele Jonsson Funk Journal: Obstet Gynecol Date: 2014-06 Impact factor: 7.661
Authors: Tony Bazi; Satoru Takahashi; Sharif Ismail; Kari Bø; Alejandra M Ruiz-Zapata; Jonathan Duckett; Dorothy Kammerer-Doak Journal: Int Urogynecol J Date: 2016-03-12 Impact factor: 2.894
Authors: Paige V Tracy; Shreya Wadhwani; Jourdan Triebwasser; Alan S Wineman; Francisco J Orejuela; Susan M Ramin; John O DeLancey; James A Ashton-Miller Journal: J Biomech Date: 2018-04-25 Impact factor: 2.712