Study purpose is to examine safety and feasibility of a novel pelvic floor dilator used during active labor to reduce pelvic floor injury.METHODS:
Pilot study evaluating performance of novel semi-automated pelvic floor dilator (Materna Medical, San Francisco). Inclusion criteria were healthy primiparas, singletons, cephalic presentation and planned epidural. At 36 weeks gestation and 12 weeks postpartum, pelvic examination was done by urogynecologist blinded to patient's course. During active labor, device was inserted in vaginal introitus to achieve preset pelvic floor dilation of 8 cm over 30–60 minute. Primary outcome was rate of lacerations, superficial skin bleeding, skin abrasion or need for surgical repair. Secondary outcomes were pelvic floor disruption diagnosed clinically, mode of delivery, and perineal lacerations (rate and degree).RESULTS:
The device was used in 21 patients; 18 delivered vaginally and 3 by cesarean. Of those who delivered vaginally, 8 patients achieved 8 cm pelvic floor dilation and 8 achieved 7 cm. There were no lacerations, superficial skin bleeding, skin abrasions or surgical repair due to device. Of the 16 patients with device in place for at least 20 minutes, 12 had 1st/2nd degree lacerations and 2 had 3rd degree lacerations. All patients with 3rd degree lacerations had operative vaginal delivery. No pelvic floor abnormalities were identified on baseline pelvic examination. No occult disruptions of pelvic floor were diagnosed clinically at 12-week postpartum.CONCLUSION:
The novel pelvic floor dilator appears to safely dilate the vaginal canal to 8 cm during active labor and no occult pelvic floor disruptions were identified.