The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study.
Assisted birth
BD Odon Device
Birth
Forceps
Intrapartum research
Ventouse
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
05 Mar 2019
05 Mar 2019
Historique:
received:
27
11
2018
accepted:
16
02
2019
entrez:
7
3
2019
pubmed:
7
3
2019
medline:
18
7
2019
Statut:
epublish
Résumé
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. 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. 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. ISRCTN, ISRCTN10203171 . Prospectively registered on 27 July 2018.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ISRCTN, ISRCTN10203171 . Prospectively registered on 27 July 2018.
Identifiants
pubmed: 30836979
doi: 10.1186/s13063-019-3249-z
pii: 10.1186/s13063-019-3249-z
pmc: PMC6402154
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
159Subventions
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/S001751/1
Pays : United Kingdom
Organisme : Bill & Melinda Gates Foundation
ID : OPP1184825
Pays : United States
Investigateurs
Mary Alvarez
(M)
Sabaratnum Arulkumaran
(S)
Nichola Bale
(N)
Natalie Blencowe
(N)
Joanna F Crofts
(JF)
Timothy J Draycott
(TJ)
Lily Exell
(L)
Anne Glover
(A)
Sally Hall
(S)
Emily J Hotton
(EJ)
Erik Lenguerrand
(E)
Helen Lewis-White
(H)
Naomi Mallinson
(N)
Michelle Mayer
(M)
Sadie McKeown-Keegan
(S)
Glen Mola
(G)
Stephen O'Brien
(S)
Alison Pike
(A)
Iona Smith
(I)
Claire Rose
(C)
Sherrie Villis
(S)
Julia Wade
(J)
Paul White
(P)
Cathy Winter
(C)
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