Mise au point sur l’Odon Device™ : amélioration technique, fonctionnement et avancée du programme de recherche clinique

Mottet, Nicolas; Bourtembourg, A.; Eckman-Lacroix, Astrid; Forner, Óscar Sancho; Mougey, Clémence; Metz, Jean; Ramanah, R.; Riethmuller, Didier

doi:10.1016/j.gofs.2020.03.011

Cited by 2 publications

(2 citation statements)

References 11 publications

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“…If found safe by the TSC, IDMC and Sponsor, findings from the ASSIST, ASSIST II Studies and parallel feasibility study in France [16] will inform the design of a randomised controlled trial that may provide evidence that supports the introduction of the device into clinical practice as a new device for AVB.…”

Section: Discussionmentioning

confidence: 99%

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy—The ASSIST II study

Hotton

Alvarez

Lenguerrand

et al. 2021

Pilot Feasibility Stud

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Background The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. Methods The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A’Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%. Discussion The data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth. Trial registration ISRCTN registration: 38829082 (prospectively registered July 26, 2019)

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Section: Discussionmentioning

confidence: 99%

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy—The ASSIST II study

Hotton

Alvarez

Lenguerrand

et al. 2021

Pilot Feasibility Stud

View full text Add to dashboard Cite

show abstract

“…Adaptations to optimise device use were adopted by the manufacturer to create Odon Device (version 4.2) which was used in two further Odon Device feasibility studies, each studying 104 Odon-assisted births. These have recently closed to recruitment in the UK 20 and France 21 and aimed to address the unanswered aspects of optimal device use, specifically the technique. These findings will be published once follow-up and data analysis is complete.…”

Section: Discussionmentioning

confidence: 99%

Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England

et al. 2022

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ObjectiveWhen novel devices are used ‘in human’ for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.DesignWe undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each ‘case’ was defined as one use of the device and included at least one of the following: observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel.SettingTertiary referral National Health Service maternity unit in the Southwest of England.ParticipantsWomen requiring a clinically indicated assisted vaginal birth.InterventionThe Odon Device, an innovative device for assisted vaginal birth.Primary and secondary outcome measuresDetermining the optimal device technique, device design and defining clinical parameters for use.ResultsThirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included: applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines.ConclusionsCase study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are introduced into clinical practice.Trial registration numberISRCTN10203171.

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Mise au point sur l’Odon Device™ : amélioration technique, fonctionnement et avancée du programme de recherche clinique

Cited by 2 publications

References 11 publications

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy—The ASSIST II study

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy—The ASSIST II study

Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England

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