Journal Article

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

O’Brien, Stephen, Crofts, Joanna F., Lenguerrand, Erik, Hotton, Emily J., Wade, Julia, Winter, Cathy, Draycott, Tim J.

2019

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Assisted birth / BD Odon Device / Biomedicine / Birth / Births / Childbirth & labor / Clinical medicine / Clinical trials / Clinical Trials as Topic / Complications and side effects / Consent / Delivery (Childbirth) / England / Equipment Design / Extraction, Obstetrical - adverse effects / Extraction, Obstetrical - instrumentation / Feasibility Studies / Female / Forceps / Health aspects / Health Sciences / Humans / Infants / Intrapartum research / Labor, Obstetric / Live Birth / Maternal mortality / Medical equipment / Medical research / Medicine / Medicine & Public Health / Midwifery / Morbidity / Mortality / Newborn infants / Obstetrics / Pregnancy / Pregnant women / Qualitative research / Respiratory system agents / Safety and security measures / Statistics for Life Sciences / Study Protocol / Surgical Instruments / Treatment Outcome / Vagina / Ventouse / Women