What is the purpose of the study?
There are two types of threads commonly used for cervical stitches. One thread is made of a single strand; the other is made of strands woven together. Woven threads are sometimes thought to be stronger and easier to remove before birth. However, they might encourage infection, which can trigger an early start to labour.
In contrast, a single strand thread is considered by some to be less likely to cause infection. However, others think this thread can cut the cervix and be harder to remove.
At the moment there is no evidence which is the best type of thread to offer to women having a stitch preventing their baby being born too soon. This is why we are doing C-STICH. Your doctor is happy to use either type of thread.
Do I have to take part?
It is entirely up to you if you want to take part in this study. You do not have to take part if you don’t want to, and you do not have to give a reason why. If you do not want to take part in this study then the standard of care you will receive will not be affected and you would still be advised to have the cervical stitch.
What would happen to me if I take part?
If you agree to take part in C-STICH you will be asked to sign a consent form.
The type of thread used will be chosen at random and neither you nor your doctor can pick what it will be, and you won’t know which type of thread is used for your stitch. You will have an equal chance of the thread being a single strand thread or a woven thread. Dividing people into groups in this way is called a ‘randomised clinical trial’ and it is the standard and most reliable way of comparing different treatments.
When the trial is finished we’d like to send your baby’s NHS number to the Health and Social Care Information Centre (HSCIC), a Department of Health sponsored public body, to see how your baby is doing up to one month after it is born. We’d also like to collect some information from your notes, including the duration of your pregnancy. You will be asked to agree to this when you sign the consent form.
What are the possible benefits of taking part?
As you have been advised you need to have a cervical stitch you may not gain any additional benefit by taking part in the study. By seeing what bacteria grow on your swab and removed stich will help doctors in treating you if any of these grow any “bad” bacteria. By taking part you will help doctors decide which is best type of thread to offer to women requiring a cervical stitch in the future.
Are there any risks?
As your doctor has recommended that you need a cervical stitch, if you take part in C-STICH then there are no additional risks
Will my taking part in this study be kept confidential?
Yes. Like your medical records all information collected in the study will be held securely and remain strictly confidential. If you agree to take part, your doctor will send basic information about you and your condition to the study’s central organisers at the University of Birmingham’s Clinical Trials Unit.
No information which can be used to identify you will be published in the study report.
Occasionally, inspections of clinical study data are undertaken to ensure that, for example, all participants have given consent to take part, so a copy of your consent form will be sent to the C-STICH study office at the University of Birmingham. The University of Birmingham and NHS Trusts are responsible for the good conduct of the C-STICH trial, so responsible individuals from these organisations may be given access to data to check we are complying with regulations. But, apart from this, only a very small number of study organisers will have access to your personal data.
Who is organising and funding the research?
C-STICH is being funded by the National Institute for Health Research’s Health Technology Assessment programme (NIHR HTA). This is a government funded organisation whose aim is to improve the standard of care in the NHS.
The study is being sponsored by the University of Birmingham and co-ordinated by their clinical trials unit.
No one involved is being paid for recruiting women into the study. Patients are not paid to take part either, but their help in finding out more about how best to prevent a cause of premature births is very much appreciated.
Who has approved the study?
This study has been approved by the Norwich and Norfolk Research Ethics Committee whose role is to ensure your safety, rights, wellbeing and dignity at all times.
This study has also been approved by each hospital taking part in the trial.
What if there is a problem?
You retain the same legal rights as any other patient treated in the National Health Service. If you are harmed by taking part in this research project, there are no special compensation arrangements. If harmed due to someone’s negligence, then you have grounds for a legal action but you may have to pay for it. If you are not satisfied with any aspect of the way you have been approached or treated during the course of this study, you should first speak to the people named on the front cover of this information sheet. If you are still unhappy and want to make a formal complaint then ask to speak to the complaints manager for the hospital. Participation in this study will not affect any private health insurance.
Where can I find the results of the study?
The results of this study will be reported in a medical journal and talked about at maternity meetings. It is expected that the first results will be published about two years after the study finishes recruiting women. A summary of the results will be available on the trial website www.birmingham.ac.uk/c-stich and from the charity SANDS www.uk-sands.org.uk