This study is trialling a new method of caesarean birth called “Time-to-Transition". “Time-to-Transition” involves a slower caesarean birth, allowing the baby time to start breathing before it is fully delivered. We propose that this may reduce the chance of babies developing “wet lungs” which can cause breathing difficulty just after birth. We will film the births so we can learn from them. We will collect information about you and your baby, from your medical records.

We will ask you to complete some questionnaires about your birth experience and whether you or your baby have had any extra healthcare in the first month after birth. If you have a birth partner, they will also be invited to complete questionnaires about the birth.

We would like to invite you to take part in the Time-to-Transition Caesarean Birth Study. Please take time to read the information and discuss it with your friends and family. A member of the research team will be happy to answer any questions you may have.

This is a small-scale “feasibility” study, to help us test how the study will run, and to learn if a larger-scale study would be possible.
This study is testing the Time-to-Transition Caesarean Birth method (explained below), which has been developed by Obstetricians and Neonatologists at Southmead Maternity Unit.

We are offering participation in this study to all women who are:

• having a planned caesarean birth at Southmead Maternity Unit
• pregnant with one baby
• and if the baby is in the “head down” position

Whilst in the womb, a baby’s lungs are filled with fluid, which helps them grow and develop. During labour and birth, most of this fluid goes away, as the baby transitions from life in the womb to breathing air. Some babies might take longer to clear this fluid after they are born, so the lungs can remain “wet” for longer, making it harder to breathe until the fluid clears. When this happens, babies breathe faster and shallower, a condition known as Transient Tachypnea of the Newborn (TTN) and they often need some additional help with breathing, antibiotics to prevent or clear infection, and sometimes a stay in a Neonatal Intensive Care Unit.

TTN is twice as common in babies born by planned caesarean than those born vaginally, as at caesarean births, babies are typically born very quickly and have less time to clear this fluid and transition to breathing air.

In this world-first study, we aim to assess a new way to perform a planned caesarean to increase the time that babies have to transition: a ‘Time-to-Transition Caesarean Birth’.

Rather than being born rapidly after opening the womb, the doctor will deliver the baby’s head and keep the body inside the womb until the baby starts to breathe or to cry, up to a maximum of 2 minutes, before delivering the baby fully. The birth will be filmed using two Hospital cameras. We will ask for your consent to be filmed. If you say no, we can film the birth in such a way that you will not be visible. You can still be involved in this Birth Partner study if you say no to being filmed.

Most of the preparation and aftercare of you and your baby will be the same as in a routine caesarean birth, but there are some important differences.

1. During the caesarean birth, your doctor will deliver your baby’s head and shoulders as normal. Then, instead of immediately birthing the rest of the baby’s body, the doctor will wait up to two minutes to allow the baby to start breathing or to cry in their own time. The doctor will then deliver the baby’s body and continue care in the normal way. This will make birth of the baby more alike a vaginal birth (where the baby’s head is typically born with one contraction, and then the body is born up to three minutes later with the next contraction).
2. Your baby’s birth will be filmed using two hospital cameras so we can check the method afterwards
3. There may be extra Hospital staff at your baby’s birth: a Research Midwife to help with research paperwork and the cameras, and a research Neonatologist to monitor the procedure.

You can still have skin-to-skin and delayed cord clamping if you would like to. As with any caesarean birth, the mother and baby will be closely monitored and if there are any concerns the baby will be immediately delivered. Everything else about the birth and recovery afterwards will remain unchanged.

We don’t know if this new method is better than a routine caesarean birth. We hope that the Time-to-Transition birth will reduce the chance your baby will have wet lungs and are less likely to need help breathing, antibiotics, or a stay in NICU. But we can’t be sure. This study will help us find out.
For that reason, we don’t know if there will be any direct benefit to you or your baby, but you may be helping families in the future once the results of this study are known.

We don’t expect the Time-to-Transition birth will be riskier to you or your baby. You will both be monitored very carefully during, and after the birth. Your baby will be birthed immediately if there are any concerns about you or your baby.

We have designed the study to take as little extra time as possible. If you decide you would like to take part, this is what will happen.

The day you have your baby

• You will come to Hospital as normal, on the day you are booked to have your baby
• You will have all the normal checks before you go to Theatre and your care team will prepare you in the normal way
• You will also be asked to confirm you’re still happy to have the Time-to-Transition caesarean birth
• We will ask you to complete a "Consent to Filming" form so we can film the birth
• You (and your birth partner if you have one) will be taken to Theatre where the usual Theatre team will be waiting for you
• There may also be a Research Midwife and a Neonatologist present.
• The Doctor will deliver the baby using the Time-to-Transition method. You and your baby will be monitored throughout in the normal way.
• After the baby is born, you will be cared for in the same way.

The day after your baby is born

• A Research Midwife will come to see you on the ward before you go home.
• We will ask you to complete a short questionnaire about your baby’s birth. It takes about 5 minutes to complete.
• We will collect some information about you and your baby from your Hospital record.

A month after your baby is born

• We will contact you at home and ask you to complete the questionnaire again.
• We will also ask you some questions about whether you or your baby have had any extra care such as GP appointments, or Hospital appointments.

If you have a birth partner, they can be present at your baby’s birth, just as they would if you weren’t part of the study. We will ask them for their consent to being filmed during the birth. If they say no, we will film the birth in such a way that they are not visible.

We would also like to invite them to be a part of the Birth Partner study which involves them completing the questionnaire about birth experiences after your baby is born. If they say no, you can still be involved in this study.

Yes, if you would like it, you can request a copy. You can still bring your own camera to take your own pictures on the day.

We don’t think your recovery time would be any different to if you were having a routine caesarean birth.
You will be cared for in the same way after the birth. More information about Caesarean birth and recovery can be found at

Caesarean Birth | North Bristol NHS Trust
(nbt.nhs.uk) or by watching this video
https://youtu.be/WEwH5WwMjoE

This study is being carried out by staff at North Bristol NHS Trust and the University of the West of England.

This study is funded by donations made to the Southmead Hospital Charity.

The Health Research Authority and South Central Berkshire Research Ethics Committee (B) REC: 23/SC/0228 IRAS project ID: 325202 have reviewed and agreed to this study.

If you are eligible and interested in learning more, a Research Midwife will talk to you and help you decide if you'd like to take part in this study. If you would still like to take part, they will ask you to complete a consent form.

You can change your mind and withdraw from this study at any time and without giving a reason, but we will keep information about you that we already have. If you do not want this to happen, tell us and we will stop. It will not affect the care that you receive, nor that of the person you are birth partner for.

We will ask you to let us know your preference by completing a study withdrawal form.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the research data we hold about you. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

All research in the UK, which uses patient information must follow UK law (the Data Protection Act) and GDPR* rules.

North Bristol NHS Trust (UK) is the Sponsor for this study. This means we are responsible for looking after your information and using it properly, according to the rules and law.

In this questionnaire study we will need to use some information about you. This information will include your name, contact details and some basic information such as your age and ethnicity. We will use your contact details to get in touch with you by phone, email, or text.

We will keep all information about you safe and secure. People who do not need to know who you are will not need to see your name or contact details. Your data will be given a code number instead. We will write our reports in such a way that no one can work out who took part in the study.

Once we have finished the research study, we will keep some of the data so that we can check the results. We will store study data for up to 5 years after the end of the project, as per standard protocol at North Bristol NHS Trust. We will write our reports in such a way that no one can work out who took part in the study.

(*GDPR stands for General Data Protection Regulation)

North Bristol NHS Trust is the sponsor for this study. You can find out more about how we use your information at:

Patient Data & Research Privacy Policy | North Bristol NHS Trust (nbt.nhs.uk)

www.hra.nhs.uk/information-about-patients.

You can also:

• Ask one of the research team
• Contact Helen Williamson (Head of Information Governance) at helen.e.williamson@nbt.nhs.uk or by calling 0117 4144767

NHS-sponsored research such as this study is covered by NHS indemnity (the same indemnity that applies to any patient in the NHS). In the unlikely event that you feel you have been adversely affected by taking part in this study, you should contact the research team as soon as possible. 

Should you wish to complain about any aspect of the way you have been approached or treated during the study, the normal NHS complaints mechanisms are available to you.

Please visit www.nbt.nhs.uk/patients-carers/feedback for further information about how to make a complaint or contact the North Bristol NHS Trust Hospital Patient Advice and Liaison Service (PALS): Telephone 0117 414 4569. PALS can also provide confidential advice and support to patients, families, and their carers.

The study is being led by Dr Joanna Crofts at Southmead Hospital (North Bristol NHS Trust). If you have any questions about the study please contact Dr Joanna Crofts, Consultant Obstetrician, Southmead Hospital either by:

The Study Email address: TTT@nbt.nhs.uk

Telephone: 01174146764

The main study is testing the Time-to-Transition Caesarean Birth method, which has been developed by Obstetricians and Neonatologists at Southmead Maternity Unit.

Rather than being born rapidly after opening the womb, the doctor will deliver the baby’s head and keep the body inside the womb until the baby starts to breathe or to cry, up to a maximum of 2 minutes, before delivering the baby fully. The birth will be filmed using two Hospital cameras. We will ask for your consent to be filmed. If you say no, we can film the birth in such a way that you will not be visible. You can still be involved in this Birth Partner study if you say no to being filmed.

As you are the birth partner of someone who has agreed to take part in the Time-to-Transition Caesarean Birth study, we would like to invite you to take part too, by sharing your thoughts about your experiences of the birth. If you decide not to take part, the person who you are birth partner to can still be involved in the study.

There will not be any direct benefit to you in taking part, but you may be helping families in the future once the results of this study are known.

This is a questionnaire study and there will be no risk to you.

To find out more about the possible benefits or risks to the caesarean birth itself, please refer to the “Time-to-Transition Caesarean Birth Study” information leaflet. (where can this be found)??

If you agree to take part, we will ask you some questions about yourself (such as age and ethnicity).

We will also ask you to complete a short questionnaire about your experience as a birth partner to a participant of the main study

• once just after the baby’s birth and
• once when the baby is about a month old.

Each questionnaire will take about 5-10 minutes to complete, and can be done over the phone, or on a smartphone or computer if you have one.

This study is being carried out by staff at North Bristol NHS Trust and the University of the West of England.

This study is funded by donations made to the Southmead Hospital Charity.

The Health Research Authority and South Central Berkshire Research Ethics Committee (B) REC: 23/SC/0228 IRAS project ID: 325202 have reviewed and agreed to this study.

If you are eligible and interested in learning more, a Research Midwife will talk to you and help you decide if you'd like to take part in this study. If you would still like to take part, they will ask you to complete a consent form.

You can change your mind and withdraw from this study at any time and without giving a reason, but we will keep information about you that we already have. If you do not want this to happen, tell us and we will stop. It will not affect the care that you receive, nor that of the person you are birth partner for.

We will ask you to let us know your preference by completing a study withdrawal form.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the research data we hold about you. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

All research in the UK, which uses patient information must follow UK law (the Data Protection Act) and GDPR* rules.

North Bristol NHS Trust (UK) is the Sponsor for this study. This means we are responsible for looking after your information and using it properly, according to the rules and law.

In this questionnaire study we will need to use some information about you. This information will include your name, contact details and some basic information such as your age and ethnicity. We will use your contact details to get in touch with you by phone, email, or text.

We will keep all information about you safe and secure. People who do not need to know who you are will not need to see your name or contact details. Your data will be given a code number instead. We will write our reports in such a way that no one can work out who took part in the study.

Once we have finished the research study, we will keep some of the data so that we can check the results. We will store study data for up to 5 years after the end of the project, as per standard protocol at North Bristol NHS Trust. We will write our reports in such a way that no one can work out who took part in the study.

(*GDPR stands for General Data Protection Regulation)

North Bristol NHS Trust is the sponsor for this study. You can find out more about how we use your information at:

Patient Data & Research Privacy Policy | North Bristol NHS Trust (nbt.nhs.uk)

www.hra.nhs.uk/information-about-patients.

You can also:

• Ask one of the research team
• Contact Helen Williamson (Head of Information Governance) at helen.e.williamson@nbt.nhs.uk or by calling 0117 4144767

NHS-sponsored research such as this study is covered by NHS indemnity (the same indemnity that applies to any patient in the NHS). In the unlikely event that you feel you have been adversely affected by taking part in this study, you should contact the research team as soon as possible. 

Should you wish to complain about any aspect of the way you have been approached or treated during the study, the normal NHS complaints mechanisms are available to you.

Please visit www.nbt.nhs.uk/patients-carers/feedback for further information about how to make a complaint or contact the North Bristol NHS Trust Hospital Patient Advice and Liaison Service (PALS): Telephone 0117 414 4569. PALS can also provide confidential advice and support to patients, families, and their carers.

The study is being led by Dr Joanna Crofts at Southmead Hospital (North Bristol NHS Trust). If you have any questions about the study please contact Dr Joanna Crofts, Consultant Obstetrician, Southmead Hospital either by:

The Study Email address: TTT@nbt.nhs.uk

Telephone: 01174146764  - between 9 am to 4pm.

Bacteria live in the intestine to help digest food. If the intestine is damaged by an operation, injury or a disease such as cancer, bacteria can leak into the space surrounding the intestine (called the abdominal cavity) and cause a serious “intra-abdominal infection.” The usual treatment for this is a course of antibiotics (usually for 7 – 18days) and sometimes surgery too. But unfortunately, these infections are complicated and the treatment doesn’t always work. In 50% of patients the infection will return, or they will develop a new one further down the line. This is called “treatment failure” and requires another course of antibiotics, and possibly more surgery.

However, current research suggests that a longer course of antibiotics may benefit these patients by preventing treatment failure and further hospital admissions. So, the EXTEND trial will be comparing an extended course of antibiotics (28 days) against the normal duration of antibiotics (7 – 18 days). Each participant will be allocated by chance into one of these two groups and will be closely monitored for the next 6 months to see if the extended course of antibiotics offers a benefit to patients by reducing the rate of treatment failure.

Principal Investigator: Anne Pullybank

Planned End Date: 30/06/2025

Local Ref (R&D no): 5187

The study aims to further medical knowledge and may improve future treatment of melanoma. The study will investigate how much skin should be removed from around the melanoma during wider excision surgery. Currently, doctors do not know how much skin to remove from around a melanoma to reduce the chances of it coming back. Guidelines in different countries vary in their recommendations on this. This study will investigate if reducing the excision margin to 1cm is as good at reducing the risk of melanoma returning as a 2cm excision margin.

Principal Investigator: Mr Ewan Wilson

Planned End Date: 01/07/2029

Recruitment to end 01/07/2025

Local Ref (R&D no): 4755

The NHS Cancer Vaccine Launch Pad (CVLP) is looking to find people who may be able to take part in research trials for personalised vaccines to treat cancer. By supporting these trials, NHS England (NHSE) aims to speed up the development of personalised treatments for cancer patients. 

We are offering patients having their cancer removed or biopsied the opportunity to have their cancer DNA analysed for changes that could be targeted for personalised treatment. The CVLP is looking for people who may be suitable for cancer vaccine research trials. Vaccines are usually used to stop people from getting a disease, such as polio or measles. Researchers are now looking at using vaccines to stop cancer coming back after it has already been treated. Cancer vaccines stimulate the body’s immune system to recognise and attack cancer cells.  

Cancer vaccines are designed using genetic (DNA) changes found in a person’s cancer. They are individually made for each person. Cancer vaccines are being tested in research trials to understand how well they work. 

Project Details

PI: Ann Lyons

Planned End date: 31/12/2030

Local Ref: 5497

Hospital acquired thrombosis describes blood clots that form in the legs and lungs after someone is treated in hospital. A clot in the leg can cause swelling, pain and other problems. If a clot in the leg breaks off and travels to the lungs, it may be life threatening. Having surgery increases the risk of developing blood clots. Blood clots in the legs and/or lungs are collectively known as venous thromboembolism (VTE).  

Doctors have known about the risks of patients developing blood clots after operations for many years and use two main ways to prevent this: 

• Thinning the blood with injections / tablets, and 

• Wearing elastic stockings to help stop blood sitting in the leg veins where it can clot. 

All participants who undergo surgery that puts them at higher risk of developing VTE require the blood thinners to be taken post discharge from hospital. Currently, some hospitals provide elastic stockings in addition to blood thinners but other hospital do not. There are no good quality research studies to show if the addition of elastic stockings reduces the risk of VTEs in patients taking blood thinners after discharge from hospital. This study is being done to find out if this is true.  

Project Details

PI: Anne Pullyblank

Planned End date: 31/07/2027

Local Ref: 5522

Perianal fistulising Crohn’s disease affects around one third of patients with Crohn’s disease during their course.  It is one of the most debilitating complications in Crohn’s disease.  Treatment methods are still evolving and approaches involving a combination of medical treatments and a number of surgical techniques are proposed.  However, the efficacy of these approaches to achieve clinically relevant outcomes is uncertain.  The majority of the recommendations are based upon expert opinion and there is relatively little scientific evidence to guide Crohn’s Disease perianal fistula (CD-pAF) management.

Our research is vital to understand the causes and consequences of problems in Crohn’s disease and improve the lives of those affected.  We aim to convert our research findings into clear improvements in health and services for people with Crohn’s disease with perianal fistula.  You could help by taking part in research that is relevant to you.  This might be to do with symptoms that you have now, or that you’ve had in the past, or even symptoms that you have never had (for comparison to other people who have).

Project Details

PI: Caroline Burt

Planned End date: 31/12/2030

Local Ref: 5495