Parent and service user information

We are undertaking research to understand why babies die around their due date in certain birth settings. We hope this research (known as a confidential enquiry) will help improve services for women, babies and families and prevent such tragedies in the future. We want to tell you about it because it may concern you.

Who's undertaking the enquiry?

The enquiry is funded by the Department of Health (DH) on behalf of the Secretary of State for Health. It will be undertaken by the National Perinatal Epidemiology Unit (NPEU) at the University of Oxford. The NPEU specialise in research around maternal and newborn health. Researchers with a long track record in maternal and newborn health at the University of Leicester as well as the Royal College of Midwives and researchers from MBBRACE-UK which runs UK-wide perinatal surveillance and confidential enquiries are also involved. (You can find out more about MBRRACE-UK on the Information about MBRRACE-UK for Health Service Users page). Representative from Sands, the stillbirth and neonatal death charity, will also be contributing to designing the enquiry and helping to communicate its results.

Why are we carrying out the ESMiE enquiry?

Every year in the UK around 400 babies are born around their due date who were alive at the start of labour but then tragically died either during labour or in the first month after birth, as a result of problems during labour or birth. The aim of the ESMiE enquiry is to identify ways in which care during labour and birth might be improved to prevent similar deaths in the future.

A national enquiry into these types of deaths is being undertaken this year as part of the national Maternal, Newborn and Infant Clinical Outcome Review Programme run by MBRRACE-UK. This programme is commissioned by the UK government to ensure that women and their families are getting safe care.

This national enquiry means that panels of health professionals including midwives and doctors specialising in the care of pregnant women (obstetricians) and the care of newborn babies (neonatologists), and other specialist doctors and nurses will look at the medical records of a number of babies who died, and those of their mothers, to see where improvements in care are needed to prevent similar deaths in the future. Because most babies are born in hospital labour wards where obstetricians work, most of the deaths the MBRRACE-UK enquiry will look at occurred in these types of birth settings. But women's birthing choices are changing in the UK, and an increasing number of women now plan to have their babies at home or in midwifery units, where obstetricians don't work, and where there is less medical intervention during labour and delivery.

The causes of baby deaths during labour in these less medicalised settings may be different and are important to know about to ensure that we are providing the best possible care for mothers wherever they decide to give birth. The ESMiE enquiry will use the same methods as the MBRRACE-UK enquiry but will focus on babies who died during or shortly after birth in the years from 2013 to 2016 (the MBRRACE-UK enquiry is focusing on deaths in 2015 only) where the mother received care in labour in a midwifery unit or at home. It will:

• carry out an in-depth confidential enquiry to review the quality of care of around 100 cases, where a baby died, to identify how care might be improved. We will look for instance at whether guidelines were followed, whether staffing was adequate and staff were properly trained and supported?
• enhance the quality of the investigations (known as a 'review') hospitals undertook into these deaths when they occurred. Did hospitals identify where gaps in care existed, for instance? And was there an action plan to ensure these failures were addressed?

The purpose of the ESMiE enquiry is to find out how the quality of care can be improved to prevent similar deaths in the future.

What does the ESMiE confidential enquiry involve?

To do this confidential enquiry, we need to:

• Identify around 100 babies who died from 2013 to 2016, where the mother received some or all of her labour care in a midwifery unit (sometimes called a birth centre) or at home, where the baby either died during labour (stillbirth) or shortly after the birth because of something that happened during labour or birth. We will do this using the national database of baby deaths that is held by MBRRACE-UK at the University of Oxford but we will only look at cases in England and Wales.
• Use this information to contact the hospital or maternity service provider where the birth took place to ask them to send us copies of the mother's and baby's medical records. The information requested includes:
  • copies of hospital medical records, reports and test results
  • letters and medical records from other doctors and other health carers such as GPs involved in pregnancy care
  • a copy of the hospital report of the local investigation (known as review) of the death where a hospital review was carried out
• This information is then sent securely to the MBRRACE-UK office at the University of Leicester

Once we have received this information:

• trained staff will remove names, addresses and any details that may identify the names of the mother and baby. This is to create what's called an 'anonymised' copy of the records. The staff who do this are trained to handle confidential medical information and have signed strict confidentiality agreements to make sure that they do not share this information with anyone else. The anonymised information collected is then reviewed in a process called a 'confidential enquiry'. This means that panels of health professionals including midwives and doctors specialising in the care of pregnant women (obstetricians) and the care of newborn babies (neonatologists), and other specialist doctors and nurses will look very thoroughly at the medical records of babies who have died, and the records of the care received by their mothers, to identify how care might be improved to prevent similar deaths in the future.
• we gather these findings together and write a report making recommendations for changes to health practice and improvements in care for women and their babies to help avoid complications and future tragedies. The final report will not contain any information that could lead to the identification of any mother or baby whose records were used in creating the report.
• the report will be circulated to all hospitals and midwifery units around the UK, as well as all the NHS organisations who pay for NHS maternity services (known as the commissioners) so that they can identify improvements in care for their own services where this is needed.
• once the ESMiE confidential enquiry is complete and the results are published any identifiable information collected for the enquiry and any links to identifiable information are destroyed to ensure that all of the information used and all of the findings remain strictly confidential.

Will I be told if my health records are used for the ESMIE confidential enquiry?

We have not sought direct consent from families to use their records for ESMiE which is focused on improving the quality of care for future women and families. The reason for this is that, in order to make contact with families to use their medical records, we would have to ask doctors or midwives who were involved in their hospital care to contact them for us. Health care professionals are often reluctant to contact parents whose babies have died because they believe that it may distress parents. This means that many parents are never asked if they would like their baby to be included in enquiries to find out how care can be improved and the enquiries are not undertaken in a meaningful way.

MBRRACE-UK has consulted bereaved parents directly as well as charities representing bereaved parents to find out how they feel about their records being used to help national learning around how to prevent similar deaths in the future. The response from the majority of parents we and they speak to, is that parents want to help stop these tragedies happening to other families and are willing to have their information used for this purpose.

In order to run ESMiE we have therefore applied for an exemption in having to seek consent from parents from the Secretary of State on the basis that the work we are undertaking is providing public benefit. This exemption has been granted to us, on the advice of the Health Research Authority Confidentiality Advisory Group (17/CAG/0017), meaning that from 1/4/17 to 31/12/18 we are able to receive copies of a sample of fully identifiable medical records from hospitals and doctors in England and Wales where the mother received care in a midwifery unit or at home and the baby is stillborn, or has died shortly after birth. We would like to assure you that once experts begin to review medical notes for the enquiry, the notes are anonymised so that individuals on the panels do not know the name of the family or the baby. This is why enquiries of this kind are described as 'confidential'.

What can you do if you do not want us to use information about you and your baby?

As explained above, we will not contact you to ask for your consent to use your records, but you do have the right to opt out of having your information used for this confidential enquiry. Please read all the information on this webpage before making a decision. If you then decide that you would prefer that your information is not used in this way please let us know by either writing to:

Professor Jenny Kurinczuk
Director, National Perinatal Epidemiology Unit
Nuffield Department of Population Health
University of Oxford Old Road Campus
Headington, Oxford OX3 7LF

Or

Telephoning to speak to Prof Jenny Kurinczuk 01865 289700

Or

Emailing: jenny.kurinczuk@npeu.ox.ac.uk

Professor Jenny Kurinczuk is the Information Guardian for the ESMiE enquiry.

Can you see a copy of the final report?

The report will be published in late 2018. You will be able to see a copy of the full report as well as a plain English summary of its findings on this page. The report will also be available on the Sands, the stillbirth and neonatal death charity.

Confidentiality

We have a legal duty to keep information about you confidential and secure. We will not share any information that identifies you for any reason, unless we have to do this by law.

All of the confidential, identifiable data used for this confidential enquiry will be handled by MBRRACE-UK staff at the University of Oxford or the University of Leicester.

MBRRACE-UK holds all records that are supplied by NHS organisations in the strictest confidence. Women and babies have the right to confidentiality under the Data Protection Act (DPA) 1998, the Human Rights Act 1998 and the common law duty of confidence: the Disability Discrimination and the Race Relations Acts also may apply.

The Data Protection Act 1998 requires organisations to notify the Information Commissioner of the purposes for which they process personal information. The details are publicly available from:

The Information Commissioner,
Wycliffe House,
Water Lane,
Wilmslow, Cheshire, SK9 5AF
or at www.ico.gov.uk

The University of Oxford is registered with the Information Commissioner's office: Z575783X.

The University of Leicester is registered with the Information Commissioner's office: Z6551415

Funding for this enquiry

This confidential enquiry is being conducted as part of the work of the Policy Research Unit in Maternal Health and Care (PRU-MHC) at the National Perinatal Epidemiology Unit (NPEU) on behalf of the Secretary of state for Health under contract to the Department of Health (DH). The Commissioner and Funder of this research is the Department of Health. The Department of Health has played no part in the design of the enquiry, will not have access to the information used in the enquiry but will receive a copy of the final report prior to publication.