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Cohort profile: Improved Pregnancy Outcomes via Early Detection (IMPROvED), an International Multicentre Prospective Cohort

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posted on 2024-07-05, 09:53 authored by Gillian M Maher, Louise C Kenny, Kate Navaratnam, Zarko Alfirevic, Darina Sheehan, Philip N Baker, Christian Gluud, Robin Tuytten, Marius Kublickas, Boel Niklasson, Johannes J Duvekot, Caroline B van den Berg, Pensee Wu, Karolina Kublickiene, Fergus P McCarthy, Ali S Khashan
Background Improved Pregnancy Outcomes via Early Detection (IMPROvED) is a multi-centre, European phase IIa clinical study. The primary aim of IMPROvED is to enable the assessment and refinement of innovative prototype preeclampsia risk assessment tests based on emerging biomarker technologies. Here we describe IMPROvED’s profile and invite researchers to collaborate. Methods A total of 4,038 low-risk nulliparous singleton pregnancies were recruited from maternity units in Ireland (N=1,501), United Kingdom (N=1,108), The Netherlands (N=810), and Sweden (N=619) between November 2013 to August 2017. Participants were interviewed by a research midwife at ~11 weeks (optional visit), ~15 weeks, ~20 weeks, ~34 weeks’ gestation (optional visit), and postpartum (within 72-hours following delivery). Findings to date Clinical data included information on maternal sociodemographic, medical history, and lifestyle factors collected at ~15 weeks’ gestation, and maternal measurements, collected at each study visit. Biobank samples included blood, urine, and hair collected at each study visit throughout pregnancy in all units plus umbilical cord/blood samples collected at birth in Ireland and Sweden. A total of 74.0% (N=2,922) had an uncomplicated pregnancy, 3.1% (N=122) developed preeclampsia, 3.6% (N=143) had a spontaneous preterm birth, and 10.5% (N=416) had a small for gestational age baby. We evaluated a panel of metabolite biomarkers and a panel of protein biomarkers at 15 weeks and 20 weeks’ gestation for preeclampsia risk assessment. Their translation into tests with clinical application, as conducted by commercial entities, was hampered by technical issues and changes in test requirements. Work on the panel of proteins was abandoned, while work on the use of metabolite biomarkers for preeclampsia risk assessment is ongoing. Future plans In accordance with the original goals of the IMPROvED study, the data and biobank are now available for international collaboration to conduct high quality research into the cause and prevention of adverse pregnancy outcomes.

Funding

FP7 Health: Health-F5-2012-305169

History

Author affiliation

President & Vice-Chancellor's Office VC: President & VC's Office

Version

  • VoR (Version of Record)

Published in

HRB Open Research

Volume

6

Publisher

F1000 Research Ltd

issn

2515-4826

eissn

2515-4826

Acceptance date

2024-06-21

Copyright date

2024

Available date

2024-07-05

Spatial coverage

Ireland

Language

en

Deposited by

Professor Philip Baker

Deposit date

2024-07-04

Data Access Statement

Researchers can apply to access IMPROvED epidemiological and biobank data by contacting IMPROvED Principal Investigator, Dr Fergus McCarthy, University College Cork, Ireland in the first instance (fergus.mccarthy@ucc.ie), followed by submission of a proposal to the IMPROvED Consortium. The data are not publicly available due to privacy/ethical restrictions and only available upon reasonable request. For further information, please email Dr Gillian Maher at gillian.maher@ucc.ie.

Rights Retention Statement

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