Assessment of cerebral perfusion with contrast‐enhanced ultrasound during constriction of the neck mimicking malposition of the <scp>BD</scp> Odon Device™: a study in newborn piglets

Lange, Charlotte de; Od, Saugstad; Solberg, Rønnaug

doi:10.1111/1471-0528.14751

Cited by 11 publications

(7 citation statements)

References 24 publications

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“…The lack of negative pressure on the fetal head, the mechanism of action of the ventouse, is designed to eliminate vacuum-associated haematoma and haemorrhage. These contentions have been supported in pre-clinical simulation studies [8][9][10].…”

Section: Introductionmentioning

confidence: 83%

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: Introductionmentioning

confidence: 83%

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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“…The BD Odon Device is the first new device for AVB since the introduction of ventouse into clinical practice in the 1950s [16]. Extensive pre-clinical simulation testing has suggested that it is not likely to generate additional pressure over the fetal head compared with current instruments [9, 17], is not likely to generate clinically significant levels of neonatal hypoxia if misplaced over the fetal carotid arteries [10], and is not likely to be associated with unsafe patterns of use by the target user population [12]. We believe that it is therefore reasonable to proceed to a clinical feasibility study of the device, and, if positive, a randomised controlled trial.…”

Section: Discussionmentioning

confidence: 99%

“…The lack of negative pressure on the fetal head, the mechanism of action of the ventouse, obviates the risk of haematoma and haemorrhage associated with ventouse. Both of these contentions have been supported in pre-clinical simulation studies [9, 10]. A first-in-human pilot study of an earlier version of the device in healthy volunteers has been completed and demonstrated that assisting birth using the device is feasible [11].…”

Section: Introductionmentioning

confidence: 99%

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study

O’Brien

Hotton²,

Lenguerrand³

et al. 2019

Trials

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Background Assisted vaginal birth 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 assisted vaginal birth (forceps and ventouse) are often not utilised in settings where there is most clinical need, resulting in maternal and neonatal morbidity and mortality which could have been prevented. The BD Odon Device is a new device for assisted vaginal birth that may be able to address this unmet need. However, before dissemination, the device requires evaluation in robust clinical trials. A feasibility study to investigate the clinical impact, safety, and acceptability of the BD Odon Device for assisted vaginal birth is therefore planned. This will provide further information on acceptability, recruitment, and the outcome data required to design a future randomised controlled trial of the BD Odon Device versus Kiwi ventouse. Methods Forty women who require an assisted vaginal birth for a recognised clinical indication will have the birth assisted with the BD Odon Device. The primary outcome is successful vaginal birth completed with the BD Odon Device. Secondary clinical outcomes include maternal and neonatal outcomes, and maternal and practitioner satisfaction. Safety data will be reviewed following every birth. Discussion A future randomised controlled trial of the BD Odon Device versus the current standard instrument (the Kiwi ventouse) is planned. The findings of the ASSIST Study will inform the randomised controlled trial design. Trial registration ISRCTN, ISRCTN10203171 . Prospectively registered on 27 July 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3249-z) contains supplementary material, which is available to authorized users.

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“…In 2013, Becton Dickinson and Company (BD) licensed the development rights of the Odon device. In consequence, the trial was paused in January 2015 for BD to conduct preclinical studies [ 13 – 15 ] and develop a new prototype. 3) The third phase included multiparous and nulliparous women with follow-up until discharge at a public tertiary hospital in Pretoria, South Africa (2017).…”

Section: Methodsmentioning

confidence: 99%

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study

et al. 2018

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BackgroundA prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study.MethodsHospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device.ResultsOf the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads.ConclusionsDelivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial.Trial registrationANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

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Assessment of cerebral perfusion with contrast‐enhanced ultrasound during constriction of the neck mimicking malposition of the BD Odon Device™: a study in newborn piglets

Cited by 11 publications

References 24 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

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study

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