ASSIST II Additional Information

ASSIST - Video of new mothers and the Research team talking about the Odon device

Video Transcript

Dr. Jo Crofts, Principle Investigator says: 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.

Participant 1 says: 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.

Participant 2 says: 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.

Participant 3 says: 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.

Participant 4 says: 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.

Dr. Jo Crofts, Principle Investigator says: 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.

ASSIST II - Additional Information

How is the study funded?

The Bill & Melinda Gates Foundation have funded this research as part of the Odon Programme. Grant number: INV-010180

Who is conducting the study?

Professor Tim Draycott (Consultant Obstetrician) is the Chief Investigator and Dr Jo Crofts (Consultant Obstetrician) is the Principal Investigator. North Bristol NHS Trust are the study Sponsors.

Who has reviewed the study?

The South Central, Berkshire Research Ethics Committee has reviewed and agreed this study (Ref 19/SC/0226).

 

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ASSIST II Contact the study team

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Email: assist@nbt.nhs.uk

Tel: 0117 4146764