Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2013-11-30
2018-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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First time, low risk mothers
The study population will consist of first time, low risk mothers attending for antenatal care in one of the participating clinical centres.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy, between 9+0 and 16+6 weeks' gestation.
* Signed informed consent.
Exclusion Criteria
* ≥ 3 miscarriages.
* ≥3 terminations of pregnancy.
* Known or suspected major fetal anomaly/abnormal karyotype.
* Essential hypertension treated pre-pregnancy.
* Moderate-severe hypertension at booking (BP \>160/100 mmHg).
* Diabetes mellitus.
* Renal disease.
* Systemic lupus erythematosus.
* Anti-phospholipid syndrome.
* Sickle cell disease.
* HIV positive.
* Hepatitis B or C positive.
* Major uterine anomaly.
* Cervical suture in situ.
* Knife cone biopsy.
* Long-term steroids.
* Treatment with low-dose aspirin.
* Treatment with heparin/LMW heparin.
* Lack of informed consent.
After recruitment, if the woman is found to be outside the stated gestation limits for the IMPROvED 1st visit of 9 weeks 0 days to 13 weeks 6 days she will be retained in the study if she is willing to take part in the second and third visit and is otherwise eligible. There is one pre-specified criteria for discontinuation of a participant. If a woman is recruited into the IMPROvED study and later identified as having a pregnancy exclusion criterion, i.e., ≥ 3 miscarriages, ≥ 3 TOPS, or using low-dose aspirin at the time of recruitment, she shall be excluded. However, women diagnosed during the pregnancy but after recruitment with an exclusion criterion, e.g., diseases such as renal disease, anti-phospholipid syndrome, etc. shall be retained within the study. Women who are recruited but later discontinue from the study do not count towards recruitment targets for each centre. Accordingly, such dropouts must be replaced.
16 Years
FEMALE
No
Sponsors
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Keele University
OTHER
University of Liverpool
OTHER
Karolinska University
OTHER
Erasmus Medical Center
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
MedSciNet AB, Stockholm, Sweden
UNKNOWN
MyCartis, Ghent, Belgium
UNKNOWN
Metabolomic Diagnostics Ltd, Cork, Ireland
UNKNOWN
Accelopment AG
OTHER
University of Groningen, The Netherlands
UNKNOWN
INFANT centre, University College Cork, Republic of Ireland
UNKNOWN
Louise Kenny
OTHER
Responsible Party
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Louise Kenny
Professor
Principal Investigators
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Louise Kenny, Professor
Role: PRINCIPAL_INVESTIGATOR
INFANT Centre, University College Cork, Ireland
Philip N Baker, Professor
Role: PRINCIPAL_INVESTIGATOR
Keele Univeristy School of Medicine
Locations
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Cork University Maternity Hospital, University College Cork
Wilton, Cork, Ireland
Erasmus Medical Center Rotterdam
Rotterdam, , Netherlands
Karolinska University Hospital Huddinge, Karolinska Institute
Stockholm, , Sweden
Liverpool Women's Hospital, University of Liverpool
Liverpool, Merseyside, United Kingdom
Keele University School of Medicine, Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, United Kingdom
Keele University School of Medicine, University Hospital of North Midlands
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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Facility Contacts
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Louise Kenny
Role: primary
Hans Duvekot
Role: primary
Karolina Kublickiene
Role: primary
Zarko Alfirevic
Role: primary
References
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McCarthy EK, Schneck D, Basu S, Xenopoulos-Oddsson A, McCarthy FP, Kiely ME, Georgieff MK. Longitudinal evaluation of iron status during pregnancy: a prospective cohort study in a high-resource setting. Am J Clin Nutr. 2024 Nov;120(5):1259-1268. doi: 10.1016/j.ajcnut.2024.08.010. Epub 2024 Sep 26.
Navaratnam K, Alfirevic Z, Baker PN, Gluud C, Gruttner B, Kublickiene K, Zeeman G, Kenny LC. A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED). BMC Pregnancy Childbirth. 2013 Dec 7;13:226. doi: 10.1186/1471-2393-13-226.
Related Links
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Official website of IMPROvED
Other Identifiers
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Project no: 305169
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Study Protocol v. 8.0 20122013
Identifier Type: -
Identifier Source: org_study_id