The ASSIST trial is a study that we’ve conducted here at North Bristol NHS Trust
in which 40 women who needed help at the end of their labour had their birth assisted with a new
device for delivering babies called the BD Odon device.
At the moment we have the choice of using, if a woman needs help at the end of her labour,
to use forceps or a ventouse, which is a suction cup, so that the doctor can help the baby be born.
So the BD Odon device was invented by an Argentinian car mechanic called Jorge Odon,
who many years ago had a party trick getting a cork out of
a bottle and suddenly thought “Oh you could try something similar with delivering a baby”.
So many years of research and development later, the BD Odon device has been produced
and it’s a plastic sleeve, which fits over the baby’s head and then there’s
an inflatable air cuff, a bit like a rubber ring when you go swimming, that is inflated
and that grasps around the baby’s head and then once that’s in position we can gently
guide the baby down through the birth canal, to help the baby be born.
A study like this has never been run in the world at all, so we were unsure how women
were going to react to being recruited to a study testing a new device.
Recruitment was amazing, the women clearly want an alternative to the forceps and the ventouse.
They were very generous and we had absolutely no problem recruiting. In fact we thought it might take
us nine months and we were finished our 40 births in three and a half months.
Today we’ve been really enjoying having a tea party that we’ve held for all the
participants, their partners and their babies, who participated in the study and we feel
it’s really important that they were the first to know the results of our study but
also to thank them for their generous participation, for the follow up that they required and to
let them know that they’ve been part of something special and that their contribution
to research is really valued.
We decided to take part in this ASSIST because they came to offer us when we were, I was
induced so I was waiting for five days in the ward so it was quite intense and they
came and said “You know what we have this in case something happens before going in to
C-section, would you like to take part in this?” and we totally went for it.
I felt it was something beneficial to both of us and it’s nice to be involved in some
research that can go on to help others.
It feels great yeah, I feel very lucky to be honest and yeah the whole experience was really
great and it could have been a lot different, so yeah I’m really really honoured to be honest.
It feels really amazing to be part of the study actually, especially today meeting all the other mums
and seeing the other babies and seeing the doctor again who delivered him, it actually
felt really special and it felt like actually we’re really making a difference.
We are planning to run a trial here, ASSIST II, which will be similar to the first study
that we did, recruiting more women and a similar trial will be run in France and then long-term
plans going forward are thinking about how we can generate enough evidence to help implement
it into practice across the world.