The OdonAssist inflatable device for assisted vaginal birth—the ASSIST II study (United Kingdom) - 08/03/24
, Nichola Bale, RM a, Claire Rose, MD a, Paul White, PhD c, Julia Wade, PhD d, Nicolas Mottet, MD, PhD e, f, Abi J. Loose, MSc a, Mohamed Elhodaiby, MD a, g, Erik Lenguerrand, PhD b, Tim J. Draycott, MD a, Joanna F. Crofts, MD aThe ASSIST II Study Group
Abstract |
Background |
Decreasing rates of assisted vaginal birth have been paralleled with increasing rates of cesarean deliveries over the last 40 years. The OdonAssist is a novel device for assisted vaginal birth. Iterative changes to clinical parameters, device design, and technique have been made to improve device efficacy and usability.
Objective |
This study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial.
Study Design |
An open-label nonrandomized study of 104 participants having a clinically indicated assisted vaginal birth using the OdonAssist was undertaken at Southmead Hospital, Bristol, United Kingdom. Data were also collected from participants who consented to participate in the study but for whom trained OdonAssist operators were not available, providing a nested cohort. The primary clinical outcome was the proportion of births successfully expedited with the OdonAssist. Secondary outcomes included clinical, patient-reported, operator-reported, device and health care utilization. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Given that the number of successful OdonAssist births was ≥61 out of 104, the hypothesis of a poor rate of 50% was rejected in favor of a good rate of ≥65%.
Results |
Between August 2019 and June 2021, 941 (64%) of the 1471 approached, eligible participants consented to participate. Of these, 104 received the OdonAssist intervention. Birth was assisted in all cephalic vertex fetal positions, at all stations ≥1 cm below the ischial spines (with or without regional analgesia). The OdonAssist was effective in 69 of the 104 (66%) cases, consistent with the hypothesis of a good efficacy rate. There were no serious device-related maternal or neonatal adverse reactions, and there were no serious adverse device effects. Only 4% of neonatal soft tissue bruising in the successful OdonAssist group was considered device-related, as opposed to 20% and 23% in the unsuccessful OdonAssist group and the nested cohort, respectively. Participants reported high birth perception scores. All practitioners found the device use to be straightforward.
Conclusion |
Recruitment to an interventional study of a new device for assisted vaginal birth is feasible; 64% of eligible participants were willing to participate. The success rate of the OdonAssist was comparable to that of the Kiwi OmniCup when introduced in the same unit in 2002, meeting the threshold for a randomized controlled trial to compare the OdonAssist with current standard practice. There were no disadvantages of study participation in terms of maternal and neonatal outcomes. There were potential advantages of using the OdonAssist, particularly reduced neonatal soft tissue injury. The same application technique is used for all fetal positions, with all operators deeming the device straightforward to use. This study provides important data to inform future study design.
Le texte complet de cet article est disponible en PDF.Key words : assisted vaginal birth, BD Odon Device, feasibility, intrapartum research, management of second stage of labor, medical device, obstetrical forceps, OdonAssist, operative vaginal delivery, perineal laceration, safety, vacuum, ventouse
Plan
| BD (Becton, Dickinson and Company) provided the OdonAssist inflatable devices for assisted vaginal birth (which was known at the time of the study as the BD Odon Device) free of charge for this study. The company had no involvement or influence in the design, conduct, or interpretation of the study. Mario Merialdi, MD, Senior Director of Global Health for BD at the time, provided certain information about the product and regulatory requirements relating thereto that were incorporated into the protocol. |
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| The views expressed are solely those of the authors and not necessarily those of the UK National Health Service. The authors are responsible for the design of the protocol and the planning, conducting, and analysis of the study. |
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| OdonAssist is a trademark of Maternal Newborn Health Innovations, PBC. The OdonAssist is a product under development by Maternal Newborn Health Innovations, PBC, and was not available for sale at the time of submission of this article. |
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| The ASSIST II study was supported by the Bill & Melinda Gates Foundation (grant number OPP1184825/INV-010180), which had no role in the study design, planning, conduct, analysis, or publication production. |
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| Clinical trial registration: ISRCTN Registry: ISRCTN38829082. Prospectively registered June 26, 2019. |
Vol 230 - N° 3S
P. S932-S946.e3 - mars 2024 Retour au numéro
Article précédent
- Assisted vaginal birth in 21st century: current practice and new innovations
- Rachna Bahl, Emily Hotton, Joanna Crofts, Tim Draycott
- Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study
- Nicolas Mottet, Emily Hotton, Astrid Eckman-Lacroix, Aude Bourtembourg, Jean Patrick Metz, Sophie Cot, Emilie Poitrey, Léa Delhomme, Eric Languerrand, Camille Nallet, Marine Lallemant, Tim Draycott, Didier Riethmuller
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