Tommy’s Net

• Research type

  Research Study

• Full title

  Tommy’s Net: A cohort study of pregnancy outcome in couples who miscarry.

• IRAS ID

  213740

• Contact name

  Siobhan Quenby

• Contact email

  Siobhan.quenby@uhcw.nhs.uk

• Sponsor organisation

  University Hospitals Coventry and Warwickshire NHS trust

• Duration of Study in the UK

  5 years, 0 months, 0 days

• Research summary

  Recurrent miscarriage is a debilitating disorder for which there is no effective medical intervention. In order to develop new interventions, we need to identify couples at high risk of future pregnancy loss. There is little published data that assesses the prognostic use of current tests and risk factors such as pregnancy loss history and BMI. There have been very few long-term follow-up studies with accurate recording of future pregnancy outcomes.

  In this project we plan a cohort study using digital technology to collect and analyse information about the patient’s history, investigation results and link these to pregnancy and neonatal outcome.

  This project will initially involve three centres with specialist clinics:
  • University Hospitals Coventry and Warwickshire NHS trust (UHCW)
  • Birmingham Women's Hospital Foundation Trust (BWH)
  • Imperial College Healthcare NHS Trust (Imperial)

  Women with a history of miscarriage will be invited to join the project and written consent will be obtained. Information will stored on the secure, NHS, N3 encrypted system in a server in UHCW. Future pregnancy outcome will be obtained by, accessing hospital and GP records and sending 6 monthly email reminders to participants requesting information. Patients will have access to their own data and be able to fill in their own history and outcomes. Access to the data will only be allowed according to the user’s role.

  The data will be interrogated for:
  ¥ Comparative, running live birth rates per clinic and per subgroup.
  ¥ Further ethical approval will be sought for studies involving sample collection and interventions, data regarding these studies will be stored on Tommy’s Net.
  ¥ Mathematical models will be created with appropriate statisticians to assess the utility of demographic data and investigations to predict pregnancy outcome and detect couples at high risk of further pregnancy loss.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  17/WM/0050

• Date of REC Opinion

  9 Mar 2017

• REC opinion

  Further Information Favourable Opinion