Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Asma Khalil
+44 (0)7917400164
Asma.Khalil@stgeorges.nhs.uk


Mrs Tracey Ricketts
+44 (0)1517959562
ricketts@liverpool.ac.uk


Prof Asma Khalil
+44 (0)7917400164
Asma.Khalil@stgeorges.nhs.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - FERN: Intervention or expectant management for early onset selective fetal growth restriction in monochorionic twin pregnancy

FERN: Intervention or expectant management for early onset selective fetal growth restriction in monochorionic twin pregnancy

Medical Conditions

Monochorionic (MC) twin pregnancies with early-onset (prior to 24 weeks) selective fetal growth restriction (sFGR)


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


The UK has approximately 11,000 twin pregnancies per year with a third of these sharing a placenta (the afterbirth), called monochorionic (MC) twins. MC twin pregnancy poses extra risks to both the mother and her babies, with some babies dying during pregnancy or shortly after birth. Often this can be due to complications of MC twin pregnancy such as selective fetal growth restriction (sFGR) where one twin is smaller than the other or twin-to-twin transfusion syndrome. sFGR affects one in seven MC twin pregnancies in the UK although less is known about pregnancies where this happens early (before 24 weeks of pregnancy). sFGR in MC twins poses some unique risks; if the smaller twin dies, its death may harm the other twin, causing either death or brain damage. There are three main ways of managing twin pregnancies with sFGR. Firstly, a watch-and-wait approach (also called expectant management). The difficulty with this approach is that the smaller twin could die in the womb, which can lead to death or brain damage to the other twin. Secondly, a procedure can be performed which blocks the umbilical cord from the smaller twin to the placenta and as a consequence, the smaller twin dies (also known as selective termination). This allows the larger twin to continue growing and gain maturity, hopefully delivering at a normal gestation. Finally, a laser can be used to completely separate the twins’ circulations. This method protects the larger twin in the event of the death of the smaller twin but increases the risk of losing the smaller twin. There is no good evidence on the best way of managing sFGR in twin pregnancies, so women and their partners are offered different management options depending on where they live and who they see. It is also clear that there are gaps in what is known about sFGR. A UK national registry of complicated twin pregnancies has already been set up to collect information about pregnancy outcomes. However, there is an urgent need for more research to see if a study comparing different management options is possible. Before running such a study, understanding is needed about things like how many twin pregnancies would be needed to run the study and whether women and clinicians would be willing to take part. Which management options will work best and what outcomes are important also need to be researched.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Jun 2022 30 Jun 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39153765/ (added 09/09/2024)2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39122401/ (added 10/09/2024)2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38956742/ (added 10/09/2024)2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38379063/ (added 10/09/2024)

Three work packages (WP) will be undertaken to help the team to define the current situation and design a future study that will inform how best to manage sFGR in MC twins.

In WP1, women (100) with sFGR in MC twin pregnancies will be recruited in 22 UK fetal medicine units over 18 months.

In WP2, interviews with parents (25) and doctors (25) will be performed to get their views about whether a bigger trial is possible and what the different types of management should be.

WP3 will develop a consensus about what is most important by seeking agreement between clinicians, parents, patient groups and funders to design the best possible study to answer the ‘What is the best way to manage MC twin pregnancies with sFGR?’.


Adults having an MC twin pregnancy and diagnosed with sFGR (WP1), parents and clinicians (WP2) and parents, clinicians and patient groups (WP3)

You can take part if:



You may not be able to take part if:


1. Singleton pregnancies2. Maternal age under 18 years3. TTTS4. Twin anaemia polycythaemia sequence before enrolment5. Other rare complicated MC twin pregnancies, such as twin reversed arterial perfusion syndrome6. Known karyotype abnormality at enrolment7. Known major fetal structural abnormality at enrolment, defined as a lethal, incurable or curable severe abnormality with a high risk of residual handicap8. Indication for immediate delivery9. Pre-term pre-labour rupture of membranes before enrolment10. Women who lack the capacity to give informed consent11. Any medical condition that compromises the woman’s ability to participate


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Oxford University Hospitals NHS Foundation Trust
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Royal Surrey County Hospital
    Egerton Road
    Guildford
    GU2 7XX
  • Guy's and St Thomas' NHS Foundation Trust
    St Thomas' Hospital Westminster Bridge Road
    London
    SE1 7EH
  • University Hospitals of Leicester NHS Trust
    Leicester Royal Infirmary Infirmary Square
    Leicester
    LE1 5WW
  • University Hospital Coventry & Warwickshire
    Clifford Bridge Road Walsgrave
    Coventry
    CV2 2DX
  • Leeds General Infirmary
    Great George Street
    Leeds
    LS1 3EX
  • The Royal Victoria Infirmary and Associated Hospitals NHS Trust
    Queen Victoria Road
    Newcastle upon Tyne
    NE1 4LP
  • East Surrey Hospital
    Canada Avenue
    Redhill
    RH1 5RH
  • Birmingham Women's Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2TG
  • Royal Infirmary of Edinburgh at Little France
    51 Little France Crescent Old Dalkeith Road Edinburgh
    Lothian
    EH16 4SA
  • Princess Anne Hospital
    Coxford Road
    Southampton
    SO16 5YA
  • London North West University Healthcare NHS Trust
    Northwick Park Hospital Watford Road
    Harrow
    HA1 3UJ
  • Kingston Hospital
    Galsworthy Road
    Kingston Upon Thames
    KT2 7QB
  • Burnley General Hospital
    Casterton Avenue
    Burnley
    BB10 2PQ
  • Birmingham Heartlands Hospital
    Bordesley Green East Bordesley Green
    Birmingham
    B9 5SS
  • Manchester University Hospital NHS Ft (hq)
    Oxford Road
    Manchester
    M13 9WL
  • Liverpool Women's NHS Foundation Trust
    Liverpool Womens Hospital Crown Street
    Liverpool
    L8 7SS
  • The Royal Jubilee Maternity Service
    274 Grosvenor Road
    Belfast
    BT12 6BA
  • St. George's Hospital (lanesborough Wing)
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Jessop Wing
    Tree Root Walk
    Sheffield
    S10 2SF
  • St Michael's Hospital
    Southwell Street
    Bristol
    BS2 8EG
  • Barts and the London NHS Trust
    Alexandra House The Royal London Hospital Whitechapel
    London
    E1 1BB

The study is anticipated to determine the current UK practice and number of cases/year, the natural history of sFGR in MC twins, pregnancy outcomes, women's preference, clinicians' preference, ethical dilemmas, whether it is feasible to conduct a trial of active intervention versus expectant management in sFGR in MC twins and the key elements of a potential future trial design.
There are no risks taking part in this study.

Prof Asma Khalil
+44 (0)7917400164
Asma.Khalil@stgeorges.nhs.uk


Prof Asma Khalil
+44 (0)7917400164
Asma.Khalil@stgeorges.nhs.uk


Mrs Tracey Ricketts
+44 (0)1517959562
ricketts@liverpool.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Liverpool and funded by NIHR HTA.




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Read full details for Trial ID: ISRCTN16879394

Or CPMS 47201

Last updated 10 September 2024

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