REALITY (REAL world evidence preeclampsIa sTudY)

  • Research type

    Research Study

  • Full title

    A multicenter, prospective, observational study to evaluate the use of the sFlt-1/PlGF ratio in the risk stratification of pregnant women with the presence of preeclampsia or related signs and symptoms in current clinical practice.

  • IRAS ID

    297659

  • Contact name

    Janine de Haan

  • Contact email

    janine.dehaan@oxonepi.com

  • Sponsor organisation

    Roche Diagnostics International Limited

  • Duration of Study in the UK

    1 years, 10 months, 1 days

  • Research summary

    The purpose of this study is to:
    Investigate further exactly how useful the blood test (sFlt-1/PlGF ratio) is to identify mothers who are at risk and not at risk of developing problems with their pregnancy or baby due to preeclampsia.
    This blood test, technically known as the sFlt-1/PlGF ratio (Soluble Fms-like tyrosine kinase 1/Placental Growth Factor), helps doctors to manage pregnancy in women who have, or maybe are at risk of preeclampsia later in their pregnancy.

    Preeclampsia is a condition which some mothers develop later in pregnancy identified by a raised blood pressure and increased protein in the urine. The condition resolves after birth. However, in some mothers it can cause problems for the pregnancy and baby.

    The study is purely observational, meaning no additional assessments, attests or procedures are requested outside of the patient's standard care. The blood test is taken as part of the patient's routine care as determined by her doctor to manage her pregnancy and will be the same as if she decides not to participate in the study.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    21/EM/0195

  • Date of REC Opinion

    10 Aug 2021

  • REC opinion

    Favourable Opinion