What is the purpose of the study?
The purpose of this study is to test which is the best drug treatment for the medical management of missed miscarriage. In this study, we will test if taking an extra tablet (called mifepristone) in addition to the standard treatment (a drug called misoprostol) is more effective for treating missed miscarriage.
Do I have to take part?
Participation in our study is entirely voluntary. If you decide to take part, you will be asked to sign a consent form. If you do not wish to take part, you will not have to give a reason and your decision will not affect the care you will receive. Similarly, if you do decide to take part, you will be able to withdraw from the study at any time and without giving a reason, and without any effect on the medical care that you receive.
What does being in the study involve?
This study will fit into your usual care. If you decide to take part in the study, the only requirement will be for you to return to hospital two days later to receive your misoprostol treatment. You will also be required to return to the hospital seven days later to undergo a routine ultrasound scan to check whether your miscarriage has resolved at this stage.
We will collect most of our study information from your hospital notes but we may need to contact you to check some details. We will ask you to complete a short questionnaire to record how you are feeling at your hospital visits and upon discharge.
We would also like you to complete a survey at the end of the study that will record your experiences of taking part in the study. You may also be contacted by one of our research team from the University of Birmingham to be interviewed in more depth about your experiences. Please tell us if you would prefer to be contacted by phone, email or post.
We would also like to contact you after your participation in the study has ended, to ask your permission to follow up the effects of the study for you in the long term.
What are the possible benefits of taking part?
We do not know whether you will benefit personally from taking part in this study, but the knowledge gained thanks to your help will inform future treatment and potentially lead to improved treatment of miscarriage for women in the future.
Are there any risks?
Mifepristone blocks the action of the hormone progesterone to help speed up the process of miscarriage. As a consequence, you may experience increased vaginal bleeding. All patients who take part will receive misoprostol, which helps your uterus contract to push out the pregnancy tissue and can cause period-like cramps, sickness, diarrhoea and flu-like symptoms.
If I take part will I have mifepristone or placebo?
Neither you nor your doctor or nurse/midwife will be able to choose which treatment you receive. Your place in the mifepristone group or the placebo group will be decided by a computer at the MifeMiso Trial Office. The computer will allocate the treatment randomly, like tossing a coin. You will have an equal chance of receiving the mifepristone treatment or the placebo treatment. In addition, neither you nor your doctor or nurse/midwife will know your allocation to the mifepristone group or the placebo group throughout the study. This method of research is called a “double blind randomised controlled trial”. Everyone who takes part in the study will be treated two days later with the standard treatment (misoprostol).
Will my taking part in this study be kept confidential?
All the information collected in the MifeMiso study will be handled strictly in accordance with your consent and the current Data Protection Act. An external database provider will be used to securely store information about you. If you decide to participate in the study, your doctor may send basic information about you to the study organisers at the University of Birmingham. All the information will be held securely and in strictest confidence, and used only for research purposes. You will not be identified in any published results of the study.
Occasionally, inspections of clinical study data are undertaken by statutory regulators, to verify the quality of the research. But otherwise, only authorised members of the research team will have access to any information collected from you.
At the end of the study your data will be archived in accordance with Research Governance Framework guidelines and the NHS Trust policy of your participating centre.
University of Birmingham is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Birmingham will keep identifiable information about you for 25 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information at: https://www.birmingham.ac.uk/privacy/index.aspx
Who has organised and reviewed the research?
This study has been funded by the National Institute for Health Research (NIHR). It is organised, managed and coordinated by the University of Birmingham, and data will be collected and stored by this institution. The study is sponsored by the University of Birmingham.
This study has been reviewed by the NHS Research and Ethics Committee West Midlands - Edgbaston (REC). The REC looks after the rights, well being and dignity of patients. This study was also reviewed by the NIHR to ensure it met the necessary scientific standards. Additionally the study will be supervised on a regular basis by a Data Monitoring and Ethics Committee (DMEC) and a Trial Steering Committee (TSC). The primary role of the DMEC is to ensure the absolute safety of all participants in the study.
The doctors and nurses/midwives caring for you will not receive any payments for recruiting women into the study. Our study participants will not be paid either, but they will be greatly appreciated, and they will be important in finding out more about how to treat miscarriage.
What if there is a problem?
If you take part in the study, then you will retain the same legal rights as any other patient within the National Health Service. If you are not satisfied with any aspect of the way in which you have been approached or treated during the course of our study, then please speak first to the researchers (contact details are on the front cover of the patient information leaflet).
If you wish to complain formally, then the normal National Health Service complaints mechanisms will be available to you: please ask to speak to the Patients Advisory and Liaison Service (PALS) Manager for the Hospital.
Where can I find the results of the study?
When the results of the study are known, we will inform you of the overall findings by email and/or via our website. We will also publish the overall findings of the study in medical journal(s), for consideration by the National Institute for Health and Care Excellence (NICE).
Where can I find more information?
If you have any questions about the study now or later, please ask your nurse/midwife or doctor.
The UK Clinical Research Collaboration has produced a guide entitled, ‘Understanding Clinical Trials’. This leaflet can be downloaded from their website: www.ukcrn.org.uk and could be useful if you are interested in learning more general information about clinical research.