Original Research
Obstetrics
Outcomes of the novel Odon Device in indicated operative vaginal birth

https://doi.org/10.1016/j.ajog.2020.12.017Get rights and content
Under a Creative Commons license
open access

Background

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.

Objective

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.

Study Design

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.

Results

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 applicator).

Conclusion

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, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary.

Key words

assisted vaginal birth
feasibility
fetal compromise
intrapartum research
management of second stage of labor
medical device
nonreassuring fetal heart tracing
obstetrical forceps
prolonged second stage of labor
safety
vacuum
ventouse

Cited by (0)

E.L. is a member of the University of Bristol (UoB) and part of his salary is paid by the PROMPT Maternity Foundation (PMF) to UoB; PMF has received funding from a Saving Lives at Birth award via a subcontract from Becton, Dickinson and Company (BD) to conduct preclinical simulation studies of the Odon Device; these funds have been used toward the salary of S.O.B., T.J.D., and J.F.C. when undertaking the simulations studies. T.J.D. and J.F.C. have acted as unpaid consultants to Limbs and Things, Ltd, the manufacturer of the PROMPT Birth Trainer—the mannequin used for simulation training for the Odon Device. All other authors report no conflict of interest.

BD provided the Odon Device for this study with no charge. They had no say in the design, conduct, or interpretation of the study. Mario Merialdi, MD, senior director of BD Global Health, provided certain information about the Odon Device and regulatory requirements relating thereto that were incorporated into the protocol.

The views expressed were those of the authors and not necessarily those of the United Kingdom National Health Service. The authors were responsible for the design of the protocol and the planning, conducting, and analysis of the study.

The ASSIST Study was supported by the Bill & Melinda Gates Foundation (grant number OPP1184825/INV-010180). The Foundation’s role was solely as funder and had no role in the design, planning, conduct, analysis, or publication production of the study.

This study is registered in the ISRCTN registry (ISRCTN10203171).

Cite this article as: Hotton EJ, Lenguerrand E, Alvarez M, et al. Outcomes of the novel Odon Device in indicated operative vaginal birth. Am J Obstet Gynecol 2021;224:607.e1-17.