Cohort profile: Improved Pregnancy Outcomes via Early Detection (IMPROvED), an International Multicentre Prospective Cohort [version 1; peer review: 1 approved with reservations]

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.

Abstract

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.

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 [version 1; peer review: 1 approved with reservations]. HRB Open Research, 6(65), https://doi.org/10.12688/hrbopenres.13812.1

• Journal Article Type: Article
• Acceptance Date: Nov 13, 2023
• Online Publication Date: Nov 13, 2023
• Publication Date: 2023-11
• Deposit Date: Jan 31, 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
• DOI: https://doi.org/10.12688/hrbopenres.13812.1
• Keywords: Cohort profile, preeclampsia, biobank, clinical data
• Public URL: https://keele-repository.worktribe.com/output/719667
• Publisher URL: https://hrbopenresearch.org/articles/6-65/v1