FERN
Research type
Research Study
Full title
FERN: Intervention or Expectant Management for Early Onset Selective Fetal Growth Restriction in Monochorionic Twin Pregnancy
IRAS ID
286337
Contact name
Asma Khalil
Contact email
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Monochorionic (MC) twin pregnancies complicated by selective fetal growth restriction (sFGR) have high rates of fetal morbidity and mortality and at present there is a lack of evidence to inform the best way of managing such pregnancies, especially where this happens early in pregnancy.
FERN, a prospective UK multicentre study, aims to determine the feasibility of conducting a trial of active intervention versus expectant management in sFGR in MC twins whilst also examining women’s and clinician’s preferences, ethical dilemmas, current UK practice, cases number per year, natural history of sFGR and key elements of a potential future trial design.
To achieve these aims the study will use a mixed methods approach of 3 work packages.
Work Package 1 will build on experiences from our recent survey of practice and the Twins Trust supported Twin-to-Twin Transfusion Syndrome registry to collect prospective data on pregnancy management and clinical outcomes. 15 UK Fetal Medicine Units will recruit 120 women with an MC twin pregnancy affected by early onset (prior to 24 weeks) sFGR. We will assess management strategies and clinical outcomes from routine practice to determine the natural history of sFGR, distribution of interventions and pregnancy outcomes.
Work Package 2 will assess 25 parent’s and 25 clinician’s preferences via interviews and focus groups to identify ethical concerns and barriers to randomisation to management options.
Work Package 3 will utilise the information provided in work packages 1 and 2 to develop a consensus on a future definitive study. We will use Delphi methodology involving all stakeholder groups (patients, clinicians, funders, charities) to reach a consensus over two rounds. If appropriate, we will then be able to propose a trial of active intervention versus expectant management for sFGR in MC twin pregnancy.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
20/SW/0156
Date of REC Opinion
4 Dec 2020
REC opinion
Further Information Favourable Opinion