Evidence map›Paper›PMID 24314209›Full record

Trial reportBMC pregnancy and childbirth2013

A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED).

Kate Navaratnam, Zarko Alfirevic, Philip N Baker, Christian Gluud, Berthold Grüttner, Karolina Kublickiene, Gerda Zeeman, Louise C Kenny

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC pregnancy and childbirth, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Generation and validation of a universal perinatal database and biospecimen repository: PeriBank.Journal of perinatology : official journal of the California Perinatal Association · 2016
    Article
  12. Review
  13. Review
  14. Review
  15. Risk factors and effective management of preeclampsia.Integrated blood pressure control · 2015
    Review
  16. Pre-eclampsia: an update.Current hypertension reports · 2014
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Kate NavaratnamCentre for Womens Health Research, University of Liverpool, First Floor, Liverpool Women's Hospital, Crown Street, Liverpool L8 7SS, UK. Kate.Navaratnam@Liverpool.ac.uk.
Zarko Alfirevic
Philip N Baker
Christian Gluud
Berthold Grüttner
Karolina Kublickiene
Gerda Zeeman
Louise C Kenny

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background5% of first time pregnancies are complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful screening test exists; consequentially clinicians are unable to offer targeted surveillance or preventative strategies. IMPROvED Consortium members have pioneered a personalised medicine approach to identifying blood-borne biomarkers through recent technological advancements, involving mapping of the blood metabolome and proteome. The key objective is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia. METHODS/

designWe report the design of a multicentre, phase IIa clinical study aiming to recruit 5000 low risk primiparous women to assess and refine innovative prototype tests based on emerging metabolomic and proteomic technologies. Participation involves maternal phlebotomy at 15 and 20 weeks' gestation, with optional testing and biobanking at 11 and 34 weeks. Blood samples will be analysed using two innovative, proprietary prototype platforms; one metabolomic based and one proteomic based, both of which outperform current biomarker based screening tests at comparable gestations. Analytical and clinical data will be collated and analysed via the Copenhagen Trials Unit. DISCUSSION: The IMPROvED study is expected to refine proteomic and metabolomic panels, combined with clinical parameters, and evaluate clinical applicability as an early pregnancy predictive test for pre-eclampsia. If 'at risk' patients can be identified, this will allow stratified care with personalised fetal and maternal surveillance, early diagnosis, timely intervention, and significant health economic savings. The IMPROvED biobank will be accessible to the European scientific community for high quality research into the cause and prevention of adverse pregnancy outcome.

trial registrationTrial registration number NCT01891240The IMPROvED project is funded by the seventh framework programme for Research and Technological development of the EU. http://www.fp7-improved.eu/

Indexed as

Pregnancy OutcomeEarly DiagnosisFemaleGestational AgeHumansMetabolomicsPredictive Value of TestsPre-EclampsiaPregnancyProteomicsResearch Design

Identifiers

PMID24314209
PMCPMC4029471

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.