COPE: The Carboprost or Oxytocin Postpartum haemorrhage Effectiveness Study. Carboprost vs Oxytocin as the First Line Treatment of Primary Postpartum Haemorrhage. A phase IV, double-blind, double-dummy, randomised controlled trial.
Bleeding after childbirth (postpartum haemorrhage, PPH) is a common and potentially serious problem affecting 1 in 20 women.
Trials of PPH are very difficult to carry out because it is hard to predict and represents a clinical emergency when it occurs. As a result, guidance on PPH treatment comes largely from studies of drugs for PPH prevention and expert opinion. UK and international health organisations have therefore called for studies to see which drug is the most effective for initial PPH treatment.
The COPE study will compare two common treatments - oxytocin and carboprost. Oxytocin is routinely used as first option. Carboprost (a prostaglandin) contracts the uterus through a different mechanism to oxytocin. There is evidence that it is more effective than oxytocin, but it is usually reserved for second/third line therapy.
Yes. We will follow strict ethical and legal practice so that all information collected about you during the study is kept strictly confidential. With your permission, we will send a letter to your GP to let them know you are taking part and use your NHS number to access anonymised data about your hospital admissions.
Any information with your name on it (such as the consent form) that has to be transferred to the coordinating centre in Liverpool, will be sent securely and only accessed by people working on the study or working to ensure the study is being run correctly. When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
Our results will guide clinical practice for PPH. We plan to present the results of the study at conferences and publish them in medical journals so that we can explain to the medical community what our research results have shown. Confidentiality will be ensured at all times and you will not be identified in any publication.
The NHS organisations routinely collect information about your inpatient, outpatient and any Accident & Emergency hospital care. In England and Wales the data are referred to as ‘Hospital Episode Statistics’ or HES data, whilst in Scotland the data are referred to as ‘Scottish Morbidity Records’ or SMR data; these are regarded as a special category of information.
The study team will retrieve information from your electronic hospitalisation records held by NHS Digital (https://digital.nhs.uk) for patients in England; NHS Wales Informatics Service Information Services (https://dhcw.nhs.wales/) for patients in Wales; and the electronic Data Research and Innovation Service (https://www.publichealthscotland.scot/) for patients in Scotland. Researchers at Bangor University, who are part of the COPE study, want to use your HES and SMR data to calculate the overall costs of care. These data will be collected for the period from three months prior to the start of the study and for the duration of the study. To retrieve your HES or SMR records, information to identify you including your name, date of birth, NHS Number (or CHI Number in Scotland) and COPE Study Number, will be securely transferred by the COPE research team in the University of Liverpool to each of the organisations listed above who hold your electronic hospitalisation records. Towards the end of the study, they will in turn, securely transfer your pseudo-anonymised HES or SMR records to Bangor University using an encrypted electronic transfer system. The data is referred to as ‘pseudo-anonymised’ data because whilst all your identifying details (name, date of birth, postcode, NHS (or CHI) Number) will have been removed, there is still a unique COPE Study Number present in the data. Your electronic HES and SMR records will be stored on secure Bangor University computer servers which meet NHS data security standards.
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.
Your NHS hospital will collect information from you and your medical records for this research study in accordance with our instructions.
Your NHS hospital will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the University of Liverpool and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your NHS hospital will pass these details to the University of Liverpool along with the information collected from you and your medical records. The only people in the University of Liverpool who will have access to information that identifies you will be people who need to contact you to in relation to the study or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
Your NHS hospital will keep identifiable information about you from this study for 25 years after the study has finished.