Cohort profile: Improved Pregnancy Outcomes via Early Detection (IMPROvED), an International Multicentre Prospective Cohort.
Autor: | Maher GM; INFANT Research Centre, University College Cork, Cork, T12YE02, Ireland.; School of Public Health, University College Cork, Cork, T12XF62, Ireland., Kenny LC; Department of Women's and Children's Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, L693BX, UK., Navaratnam K; Department of Women's and Children's Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, L693BX, UK., Alfirevic Z; Department of Women's and Children's Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, L693BX, UK., Sheehan D; INFANT Research Centre, University College Cork, Cork, T12YE02, Ireland., Baker PN; College of Life Sciences, University of Leicester, Leicester, LE17RH, UK., Gluud C; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, The Capital Region, Copenhagen, DK2200, Denmark.; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, DK5230, Denmark., Tuytten R; Metabolomic Diagnostics, Cork, T45YX04, Ireland., Kublickas M; Department of Fetal Medicine, Karolinska University Hospital, Stockholm, SE17176, Sweden., Niklasson B; Department of Nursing Science, Sophiahemmet University, Stockholm, SE11486, Sweden., Duvekot JJ; Department of Obstetrics and Gynecology, Division of Obstetrics and Prenatal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, 3015GD, The Netherlands., van den Berg CB; Department of Obstetrics and Gynecology, Division of Obstetrics and Prenatal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, 3015GD, The Netherlands., Wu P; School of Medicine, Keele University, Staffordshire, ST55BG, UK., Kublickiene K; Division of Renal Medicine, CLINTEC, Karolinska Institutet, Stockholm, SE14152, Sweden., McCarthy FP; INFANT Research Centre, University College Cork, Cork, T12YE02, Ireland.; Department of Obstetrics and Gynaecology, University College Cork, Cork, T12YE02, Ireland., Khashan AS; INFANT Research Centre, University College Cork, Cork, T12YE02, Ireland.; School of Public Health, University College Cork, Cork, T12XF62, Ireland. |
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Jazyk: | angličtina |
Zdroj: | HRB open research [HRB Open Res] 2024 Jun 24; Vol. 6, pp. 65. Date of Electronic Publication: 2024 Jun 24 (Print Publication: 2023). |
DOI: | 10.12688/hrbopenres.13812.3 |
Abstrakt: | 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. Competing Interests: Competing interests: RT is an employee of Metabolomic Diagnostics. RT is a named inventor on several patent applications regarding the use of biomarkers to predict preeclampsia risk; the associated rights are assigned to Metabolomic Diagnostics. PNB and LCK are minority shareholders in Metabolomic Diagnostics, which seeks to develop predictive tests for major pregnancy complications. All other authors have no conflicts of interest to disclose, including financial interest. (Copyright: © 2024 Maher GM et al.) |
Databáze: | MEDLINE |
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