O'Brien, S; Hotton, EJ; Lenguerrand, E; Wade, J; Winter, C; Draycott, TJ; Crofts, JF; ASSIST Study Group
(2019)
The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study.
Trials, 20 (1).
p. 159.
ISSN 1745-6215
https://doi.org/10.1186/s13063-019-3249-z
SGUL Authors: Arulkumaran, Sabaratnam
Abstract
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.
Item Type: |
Article
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Additional Information: |
© The Author(s). 2019
Open Access
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: |
Assisted birth, BD Odon Device, Birth, Forceps, Intrapartum research, Ventouse, ASSIST Study Group, BD Odon Device, Forceps, Ventouse, Assisted birth, Birth, Intrapartum research, 1102 Cardiovascular Medicine And Haematology, 1103 Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine |
SGUL Research Institute / Research Centre: |
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) |
Journal or Publication Title: |
Trials |
ISSN: |
1745-6215 |
Language: |
eng |
Dates: |
Date | Event |
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5 March 2019 | Published | 16 February 2019 | Accepted |
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Publisher License: |
Creative Commons: Attribution 4.0 |
Projects: |
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PubMed ID: |
30836979 |
Web of Science ID: |
WOS:000460486700001 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/110777 |
Publisher's version: |
https://doi.org/10.1186/s13063-019-3249-z |
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