Abstract:Objective To investigate (1) the placement of the BD Odon Device on the model fetal head and (2) perineal distention during simulated operative vaginal births conducted with the BD Odon Device.Design Observational simulation study.Setting North Bristol NHS Trust, UK.Population or sample Four hundred and forty simulated operative vaginal births.Methods Three bespoke fetal mannequins were developed to represent (1) bi-parietal diameter of the 50th centile at term, (2) bi-parietal diameter at the 5th centile at t… Show more
“…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.…”
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.
“…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.…”
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.
“…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 – 10 ]. Fig.…”
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)
“…17 The Odon Device (figure 1) was invented by an Argentinean Car Mechanic and then further developed by a multiprofessional team of doctors, midwives and engineers as an alternative device. [18][19][20][21][22] The device consists of a plastic applicator and polyethylene sleeve. The sleeve is placed over the fetal head and contains a circumferential air chamber that is inflated, providing purchase for the operator to apply traction.…”
Section: Strengths and Limitations Of This Studymentioning
ObjectiveTo investigate women’s experiences of having a birth assisted by the Odon Device (an innovative device for assisted vaginal birth) and participation in intrapartum research.DesignQualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study.SettingA tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019.ParticipantsEight women, four operators and 11 midwives participated with eight observations of the assisted vaginal birth, eight interviews with women in the postnatal period, 39 interviews/reflections with operators and 19 interviews with midwives. Women in the case study research were recruited from participants in the main ASSIST Study.InterventionThe Odon Device, an innovative device for assisted vaginal birth.ResultsThirty-nine case studies were undertaken. Triangulation of data sources (participant observation, interviews with women, operators and midwives) enabled the exploration of women’s experiences of the Odon Device and recruitment in the intrapartum trial. Experiences were overwhelmingly positive. Women were motivated to take part by a wish for a kinder birth, and because they perceived both the recruitment and research processes (including observation) to be highly acceptable, regardless of whether the Odon-assisted birth was successful or not.ConclusionsInterviews and observations from multiple stakeholders enabled insight into women’s experiences of an innovative device for assisted vaginal birth. Applying these qualitative methods more broadly may illuminate perspectives of key stakeholders in future intrapartum intervention research and beyond.Trial registration numberISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171.
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