The TAPS Trial

  • Research type

    Research Study

  • Full title

    Fetoscopic laser surgery for Twin Anemia Polycythemia Sequence

  • IRAS ID

    311852

  • Contact name

    Asma Khalil

  • Contact email

    asma.khalil@lwh.nhs.uk

  • Sponsor organisation

    Liverpool Women's NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT04432168

  • Duration of Study in the UK

    2 years, 11 months, 31 days

  • Research summary

    Twins who share a placenta are called monochorionic (MC) twins and are higher risk as sharing a placenta can cause specific problems if the blood flow across the placenta is not shared equally – one twin can get too much blood flow, and the other twin can get too little. If the smaller blood vessels in the placenta are affected, then the twins can develop a disease called twin anaemia-polycythaemia sequence or ‘TAPS’.
    If left untreated, TAPS can lead to disabilities and even death in one or both babies.
    To treat TAPS we have several options but we do not have good evidence to recommend one treatment over another. The treatment options available to us at present are
    • Expectant management – watch and wait
    • Intrauterine blood transfusion – a blood transfusion given to the anaemic baby in the womb, with or without removing some surplus blood from the overloaded or recipient twin – an invasive procedure
    • Fetoscopic laser surgery - the connecting blood vessels on the surface of the placenta will be blocked to stop the unbalanced blood flow between the twins –an invasive procedure
    • Preterm delivery (early delivery)
    • Selective Reduction (terminating one of the babies)
    Fetoscopic laser surgery is the only intervention that treats the cause of the problem, but we do not have robust evidence to demonstrate that it is equivalent or better than the other treatment methods, therefore we propose an international, multi-centre, open-label randomized controlled trial to assess whether fetoscopic laser surgery improves the outcome of TAPS twins compared to standard care.
    P: MC twins with TAPS diagnosed between 20 and 28 weeks of gestation.
    I: Fetoscopic laser surgery
    C: Current standard of care – expectant management, IUT, preterm delivery or selective termination
    O: Gestational age at birth; perinatal mortality or severe neonatal morbidity; neurodevelopmental outcome at 2 years.

  • REC name

    South East Scotland REC 01

  • REC reference

    22/SS/0110

  • Date of REC Opinion

    14 Jun 2023

  • REC opinion

    Further Information Favourable Opinion