Gillian M Maher
Cohort profile: Improved Pregnancy Outcomes via Early Detection (IMPROvED), an International Multicentre Prospective Cohort.
Maher, Gillian M; Kenny, Louise C; Navaratnam, Kate; Alfirevic, Zarko; Sheehan, Darina; Baker, Philip N; Gluud, Christian; Tuytten, Robin; Kublickas, Marius; Niklasson, Boel; Duvekot, Johannes J; van den Berg, Caroline B; Wu, Pensee; Kublickiene, Karolina; McCarthy, Fergus P; Khashan, Ali S
Authors
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 p.wu@keele.ac.uk
Karolina Kublickiene
Fergus P McCarthy
Ali S Khashan
Abstract
BackgroundImproved 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.MethodsA 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 dateClinical 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 plansIn 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.
Citation
Maher, G. M., Kenny, L. C., Navaratnam, K., Alfirevic, Z., Sheehan, D., Baker, P. N., Gluud, C., Tuytten, R., Kublickas, M., Niklasson, B., Duvekot, J. J., van den Berg, C. B., Wu, P., Kublickiene, K., McCarthy, F. P., & Khashan, A. S. (2023). Cohort profile: Improved Pregnancy Outcomes via Early Detection (IMPROvED), an International Multicentre Prospective Cohort. HRB Open Research, 6(65), 1-19. https://doi.org/10.12688/hrbopenres.13812.2
Journal Article Type | Article |
---|---|
Acceptance Date | Nov 13, 2023 |
Publication Date | Nov 13, 2023 |
Deposit Date | Jul 12, 2024 |
Publicly Available Date | Jul 12, 2024 |
Journal | HRB open research |
Print ISSN | 2515-4826 |
Electronic ISSN | 2515-4826 |
Publisher | Taylor and Francis |
Peer Reviewed | Peer Reviewed |
Volume | 6 |
Issue | 65 |
Pages | 1-19 |
DOI | https://doi.org/10.12688/hrbopenres.13812.2 |
Keywords | Preeclampsia, Biobank, Cohort Profile, Clinical Data |
Public URL | https://keele-repository.worktribe.com/output/872190 |
PMID | 38911611 |
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Cohort profile: Improved Pregnancy Outcomes via Early Detection (IMPROvED), an International Multicentre Prospective Cohort.
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Copyright Statement
© 2024 Maher GM et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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