COPE: The Carboprost or Oxytocin Postpartum haemorrhage Effectiveness study

​​The Data will be used for the purpose of a clinical trial: The Carboprost or Oxytocin Postpartum haemorrhage Effectiveness study (COPE)

​The Data will be used to answer the following questions:

​1. To compare carboprost with oxytocin as the initial treatment for women with clinically diagnosed postpartum haemorrhage (PPH) after giving birth in UK hospitals.

​2. To assess the relative cost‑effectiveness of carboprost compared with oxytocin when used as initial treatments for PPH.

​3. To explore the views of participants and their carers about their experiences of the two treatments and the consent process.

​​University of Liverpool will transfer data to NHS England. The data will consist of identifying details (specifically Name, Postcode, NHS Number, Date of Birth, and a unique person ID) for the cohort to be linked with NHS England data. For each individual patient University of Liverpool will supply NHS England with the data period start-date (randomisation date minus 90 days) and data period end-date (randomisation date plus 28 days).​

​​NHS England will provide the relevant records from the Emergency Care Dataset (ECDS) and Hospital Episode Statistics (HES) datasets to Bangor University. The Data will contain no direct identifying data items. The Data will be pseudonymised, and individuals cannot be reidentified through linkage with other data in the possession of the recipient.​

​​Bangor University will link the HES/ECDS datasets to clinical data supplied by University of Liverpool, using the unique person ID.​

​​Following analysis of the linked data; flows from Bangor University to University of Liverpool will consist of aggregated outputs with relevant small-number suppression rules applied.​

​​The Data will be stored on servers at Bangor University.​

​​Bangor University will back-up the data using an onsite back-up server.

​​The Data will be accessed by authorised personnel via remote access.

​The Controllers must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

​For remote access:

​• Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA.

​• Access controls granting users the minimum level of access required are in place.

​• Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data.

​• Multifactor authentication (MFA) is required for remote access.

​• Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access.

​• All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

​The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

​​University of Liverpool are not permitted to access the Data.​

The Data will be linked at person record level with clinical data obtained from University of Liverpool.

​​The expected outputs of the processing will be:

​• Submissions to peer reviewed are expected within 18-months of receipt of NHS England Data.

​• Presentations at appropriate local, national, and international conferences.​

​​The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.​

​​The outputs will be communicated to relevant recipients through the following dissemination channels:

​• ​Journals

​• ​Webinars

​• ​Presentation at Maternal health conferences such as: British Maternal and Fetal Medicine Society.

​• ​Presentations to health economics audiences such as the HTAi annual meeting.

​​The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

​The use of the data could:

​• ​​lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

​• ​​inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

​• ​​inform decisions on how to effectively allocate and evaluate funding according to health needs.

​• ​​support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).​

Yielded Benefits is not a requirement for new applications.