Outcomes of the novel Odon Device in indicated operative vaginal birth

ABSTRACT Background No new methods of assisting vaginal birth have been introduced into clinical practice since the development of the vacuum in the 1950s. The Odon Device™ is a new device that employs a circumferential air cuff over the fetal head to assist birth. This is the first study where the Odon Device has been used to expedite vaginal birth for standard clinical indications. Objectives To investigate the clinical impact, safety and acceptability of the Odon Device to women, their babies and clinicians and assess the feasibility of recruiting women to an interventional intrapartum research study. Study design A non-randomized, single arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, UK. The Odon Device was used to assist birth in 40 women who required the birth to be expedited for suspected fetal compromise and/or prolonged second stage. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device and the primary feasibility outcome was the proportion eligible women who were approached and agreed to participate. Neonatal outcome data were reviewed at day 28 and maternal outcomes were investigated up to day 90. Results Between October 2018 and January 2019, 298 (77.6%) of the 384 approached, eligible women consented to participate. Of these, 40 received the intervention - the use of the Odon Device. Birth was assisted in all cephalic (OA, OT & OP) fetal positions, at all stations at or below the ischial spines and with or without regional analgesia. The Odon Device was effective in 19 of the 40 (48%) cases. In 21 births additional assistance was required: 18 (45%) were completed using non-rotational forceps, one (3%) rotational forceps, and two (5%) required an emergency Cesarean section. There were no serious maternal or neonatal adverse events related to the use of the device and there were no serious adverse device effects. Four devices (10%) were ineffective due to a manufacturing fault. Thirty-nine women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, though some steps of the device use were reported to be easier to perform (set up and deflation of air chamber) than others (application of the device and withdrawal of the applicator). Conclusions Recruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps, however this was the first time the device had been employed to expedite birth for standard clinical indications. There were no significant maternal or neonatal safety concerns associated with the use of the device, although the number of births studied was small. A further feasibility study to establish if iterative changes to the device, technique and clinical indications is now necessary.