IMproved PRegnancy Outcome by Early Detection

Summary

The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia.

This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs (small to medium size enterprise) within the consortium. The study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.

Conditions

• Pre-eclampsia
• Pregnancy
• Pregnancy, High-risk
• Pregnancy Complications

Sponsors & Collaborators

• Keele University

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Karolinska University

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• MedSciNet AB, Stockholm, Sweden

  collaborator UNKNOWN

• MyCartis, Ghent, Belgium

  collaborator UNKNOWN

• Metabolomic Diagnostics Ltd, Cork, Ireland

  collaborator UNKNOWN

• Accelopment AG

  collaborator OTHER

• University of Groningen, The Netherlands

  collaborator UNKNOWN

• INFANT centre, University College Cork, Republic of Ireland

  collaborator UNKNOWN

• Louise Kenny

  lead OTHER

Principal Investigators

• Louise Kenny, Professor · INFANT Centre, University College Cork, Ireland

• Philip N Baker, Professor · Keele Univeristy School of Medicine

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2017-10-31

Completion

2018-04-30

Countries

• Ireland
• Netherlands
• Sweden
• United Kingdom

Study Locations