The ASSIST II Study
Research type
Research Study
Full title
The BD Odon Device for assisted vaginal birth: a feasibility study to investigate safety and efficacy
IRAS ID
264660
Contact name
Timothy Draycott
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN38829082
Clinicaltrials.gov Identifier
EudraCT, 2019-001674-28
Duration of Study in the UK
0 years, 11 months, 0 days
Research summary
The ASSIST II Study is a safety and efficacy study of the BD Odon Device for women having an assisted vaginal birth (AVB). The ASSIST II Study will determine to what extent the BD Odon Device is safe and effective for women and babies who require an AVB.
In the UK approximately 80,000 women and babies have an AVB each year. Currently birth is assisted using either obstetric forceps or a ventouse (a suction cup).
Since the introduction of the ventouse to clinical practice in the 1950s there have been no new classes of instrument developed to help caregivers perform AVB. The BD Odon Device is a new device for AVB which has been designed and tested by a multi-disciplinary group of midwives, obstetricians and engineers. The BD Odon Device incorporates an air cuff to act as a traction point on the baby’s head. This may be safer and more effective than current options.
Study participants will be pregnant women in the final stage of labour (full cervical dilatation) who require an AVB. This would be because their labour has slowed down, there are concerns about their baby’s heart rate, or there is a medical reason to shorten the amount of time a woman should push for during labour. Participants, having previously provided full written consent, will undergo an AVB performed by a senior doctor using the BD Odon Device.
The study will be conducted in Southmead Hospital, part of North Bristol NHS Trust, Bristol, UK. The study will allocate 104 women and will take place over ten months. The primary outcome measure will be maternal and neonatal safety. If the ASSIST II study demonstrates positive results, a full superiority randomised controlled trial of the BD Odon Device versus current standard care (the Kiwi ventouse) for AVB will be conducted.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0226
Date of REC Opinion
29 May 2019
REC opinion
Favourable Opinion