The SMART clinic: a Feasibility Study

  • Research type

    Research Study

  • Full title

    A feasibility study of a translational research antenatal clinic for IVF-conceived pregnancies: The St Mary's After Reproductive Technology (SMART) clinic

  • IRAS ID

    276091

  • Contact name

    Lucy Higgins

  • Contact email

    lucy.higgins@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Clinicaltrials.gov Identifier

    NCT04488861

  • Duration of Study in the UK

    2 years, 11 months, 31 days

  • Research summary

    When individuals become pregnant after fertility treatment (commonly in vitro fertilisation, IVF), they more frequently experience a range of pregnancy complications including growth problems in baby, blood pressure complications and depression. Many feel that their physical and emotional needs are not met by routine pregnancy care. These complications can have long term health impacts for mother or child; we do not fully understand why. These risks might be reduced by changing the care provided during fertility treatment, pregnancy or after birth.

    This study, funded by the Academy of Medical Sciences and Tommy's and conducted at Manchester University Foundation NHS Trust, aims to understand whether it is feasible to provide a dedicated pregnancy research clinic for individual pregnant after IVF. A small team of IVF-aware doctors and midwives will study 120 pregnancies (of which, at least 80 IVF pregnancies) over a three year period. We will assess the health of the mother and baby every 4-8 weeks throughout pregnancy. This will use ultrasound, special blood pressure measurements, samples of the mother’s blood/urine/spit/hair and questionnaires. After birth we will measure baby and study the placenta.

    We aim to understand the practicalities of such a clinic, identifying and overcoming barriers to participation, and assessing the uptake of different research measurements. It will provide initial insights into when, how and why differences may arise between those who become pregnant "naturally" and those who become pregnant after IVF treatment, including whether differences in their IVF treatment (such as fresh or “frozen” embryo transfer IVF) change these risks. It will identify key measurements/time points with the greatest potential to detect and understand the causes of these complications. These care packages and tests can then be used in a full scale study to improve care and promote lifelong health for mothers and their babies.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    20/NE/0222

  • Date of REC Opinion

    16 Oct 2020

  • REC opinion

    Favourable Opinion