ASSIST II Information

Further information about the study and what would be involved if you decide to participate can be found in our 

Please take the opportunity to discuss the study with family, friends, and your Community Midwife, to work out if it’s right for you and your baby.

The ASSIST II video talks about the research in more detail and how the Odon device works.

Video Transcript:

>> NAOMI: Hello, My name’s Naomi, I’m a Midwife here at Southmead Hospital. I’d like to tell you about a study we are doing to try and improve the care that women and their babies receive should they require an assisted vaginal birth. Around 1 in 8 women require an assisted vaginal birth, and although we do try to avoid it, sometimes it is necessary. An assisted vaginal birth is where a woman will have help at the end of her labour to give birth to her baby. The doctor who provides this assistance will use the metal forceps or the suction cup. This is Dr Jo Crofts, a Consultant here at Southmead Hospital, and Jo is going to give us some more information about The Assist Study, and the Odon Device that we will be using.

>> JO: First of all I’d like to say thank you very much for taking the time to watch this video and consider being part of the Assist Study. As Naomi said, about 1 in 8 women here at Southmead, have their birth assisted using the forceps or the suction cup. Now it’s really difficult to predict how a woman will have her baby. Most women will have a spontaneous vaginal birth, also known as a normal birth, some women will require an emergency caesarean section during their labour, some will have a planned caesarean section and about 1 in 8 women will require an assisted vaginal birth in the final stages of their labour. Now we are asking for help from women who require an assisted vaginal birth at the end of their labour, but because it is difficult to predict who those women will be, we are asking a wide variety of women to consider, if in the eventuality that they needed an assisted vaginal birth, whether they would be happy to help us with this study.

>> JO: We have a new device, called the Odon Device, that has recently been developed and we would like to see how effective this is at helping babies be born. The Odon device works in a different way to the forceps or the suction cup. The Device has an inflatable cuff that sits around the baby’s head, and as the mother pushes we guide the baby down through the birth canal to help the baby be born.

>>NAOMI: OK, thank you Jo, can we see how the device works?

>>JO: Absolutely, yes, let’s have a look at the model.

>JO: OK, so Naomi, this is the Odon Device, and I can show you how this works. What we do is we put the cup inside the mother’s birth canal on to the baby’s head. When we’ve got that in position, I can then advance the applicator and this gently allows the sleeve to slip around the baby’s head, as you can see here. When it’s got to the right position, which I can see buy the zero here, I inflate the air chamber. You can see that inflating inside there. That provides a cuff around the baby’s head. I can then withdraw the applicator, and then give a couple more puffs, to ensure we’ve got the right amount of air in. Now we wait for the contraction, and as she’s got a contraction, I gently pull. We can see that there’s a blue line appearing, which means that the baby’s head is nearly born. I deflate the bag and as I do that, I can see that the baby’s head has been born. Then I can continue to help the baby’s body be born as normal.

So, as we can see from that demonstration that the plastic sleeve of the Odon device sits over the baby’s head. Some women are concerned that this may interfere with how the baby breathes. However, at this stage of labour, the baby hasn’t started to breathe yet and is getting all of its oxygen and nutrient supply from the mother’s placenta. As soon as the baby’s been born the Odon device is removed and the baby can take its first breath as normal. Also, the Odon device won’t sit around the baby’s neck as it sits around the widest part of the baby’s head which is much higher up.

>>JO: The BD Odon device has been designed by a team of midwives, doctors, engineers and specialists in the design and manufacture of medical equipment. In the same way that any new medicine requires rigorous investigation before it can be widely used, any new medical device also requires similar testing. As of March 2020, the BD Odon device has been used in over 160 births across the world. The first 49 of these births were conducted in Argentina and South Africa in a study coordinated by the World Health Organisation. Women who were about to have a normal birth (that is, they didn’t actually need an assisted birth) agreed for the doctor to use the BD Odon device in the very final moments of their labour to test how the device worked. Following this, thousands of simulated births were conducted to optimise the device design. The ASSIST Study was conducted here at Southmead and was the first study in which the BD Odon Device was used in births requiring assistance. Forty women took part. This study was very helpful in understanding which types of births the device was best used in and how the device was best used.

There are currently two studies being now being conducted to further investigate the effectiveness and safety of the BD Odon device: the ASSIST II Study here in Bristol and a parallel study in France. Both studies are collecting data on the proportion of births successfully assisted with the device, together with the outcomes of both the mothers and their babies. Whilst it is too early to directly compare the BD Odon device to the suction cup or forceps, the data we have collected so far indicates that the current success rate of the BD Odon device (between 60 and 80%) is likely to be similar to that of the suction cup. With any birth, complications such as tears or heavy blood loss for mothers, and bruising or infection for the baby, may occur. We know that the possibility of complications increase when a birth is assisted. It is not yet known if any of the risks are different when the Odon Device is used, compared to the ventouse or forceps and we are monitoring all outcomes very closely throughout the study. With the information we have so far, we know there have been no unexpected problems for mothers or babies when the Odon Device has been used compared to when the ventouse or forceps are used.

 

>>JO: If you agree to participate in the ASSIST II Study and require an assisted vaginal birth there is a small chance your baby may be born with the suction cup or forceps, rather than the BD Odon Device. There are some situations in which it is not appropriate to use the BD Odon Device, and forceps or the suction cup are therefore used. Very occasionally there may not be a doctor who has been specially trained in the use of the Odon Device available when an assisted birth is required. In this situation, you would receive routine care and the birth would be assisted with the suction cup or forceps. However, we are still very much interested in your birth experience and would like to follow you up in the same way we follow up women who have had an Odon assisted birth. If the BD Odon device is used but has not been successful at completing the birth the doctor will discuss with you the most appropriate method, for example forceps or caesarean section, to complete the birth of your baby.

 

>>LILY: Hi, I’m Lily, and I’m a midwife here at Southmead Hospital and also part of the Assist II study team. If you agree to be a potential participant in the Assist II Study, should you require an assisted vaginal birth, rather than using the suction cup or the forceps, the doctor assisting your birth will use the Odon Device. There may also be another member of the Assist II study team present at your birth. This may be somebody that you have already met, or who may complete your follow up. The midwife providing your labour care will complete our study paperwork.

 

On the following day a member of the Assist II study team will come and visit you on the postnatal ward. We will ask you a few short questions about your birth experience, and ask you a health questionnaire. We will also meet and review your baby and complete our day 1 postnatal follow up. This will not delay you going home. We would also like to follow you up over the telephone at times at your convenience. We will follow you up on day 7, day 28 and day 90. We will ask you a few short questions, again about your birth experience and a health questionnaire. We will ask you if you’ve had any hospital appointments or have seen your GP within the first 4 weeks after having your baby. This also provides you with the opportunity to speak to a healthcare professional over the telephone and ask any questions. This is Dr Claire Rose, one of our Neonatal Consultants here at Southmead. She will provide you with some information about the follow up for your baby.

 

>>CLAIRE: Thank you Lily. Again, thank you for taking time to consider taking part in this study which aims to improve the care of mothers and their babies. Every baby has a thorough examination in the first 24 to 72 hours after birth. This is called the Newborn Infant Physical Examination or NIPE and is performed by a specially trained midwife or member of the neonatal medical team. Information from the NIPE will be added to your Study paperwork. In addition, each baby will have a set of observations taken at 2 and 6 hours of age. These take less than a minute to complete, and will be performed by the midwife caring for you and your baby, so they won’t interfere with feeding or bonding. On day 28, myself or my Consultant colleague will review your baby’s hospital notes and any additional information needed for the study will be added to the study paperwork that is kept securely in the study office.

 

>>JO: Thank you for listening. To find out more, please speak to a member of the study team. You can call or email us, register your interest on our website, or speak to a Research Midwife when you are in the Maternity Unit.

ASSIST II Contact the study team

You can email or phone us.

Email: assist@nbt.nhs.uk

Tel: 0117 4146764

ASSIST II Register your Interest

Please complete the ASSIST II registraton form to see if you are able to take part.
ASSIST II register your interest