Outcomes of the novel Odon Device in indicated operative vaginal birth

• Published in: American journal of obstetrics and gynecology 2021-06, Vol.224 (6), p.607.e1-607.e17
• Main Authors: Hotton, Emily J., Lenguerrand, Erik, Alvarez, Mary, O’Brien, Stephen, Draycott, Tim J., Crofts, Joanna F., Arulkumaran, Sabaratnam, Bale, Nichola, Blencowe, Natalie S., Draycott, Timothy J., Exell, Lily, Glover, Anne, Hall, Sally, Lewis-White, Helen, Mallinson, Naomi, Mayer, Michelle, McKeown-Keegan, Sadie, Mola, Glen, Pike, Alison, Smith, Iona, Rose, Claire, Villis, Sherrie, Wade, Julia, White, Paul, Winter, Cathy
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; assisted vaginal birth; Equipment Failure - statistics & numerical data; Extraction, Obstetrical - instrumentation; Extraction, Obstetrical - methods; feasibility; Feasibility Studies; Female; fetal compromise; Follow-Up Studies; Humans; intrapartum research; management of second stage of labor; medical device; nonreassuring fetal heart tracing; Obstetric Labor Complications - therapy; obstetrical forceps; Original Research; Patient Satisfaction - statistics & numerical data; Pregnancy; prolonged second stage of labor; safety; Treatment Outcome; vacuum; ventouse; Young Adult
• ISSN: 0002-9378; 1097-6868; 1097-6868
• DOI: 10.1016/j.ajog.2020.12.017

No new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications. This study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study. This is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Between October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention—the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicat