Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia
NCT ID: NCT06085001
Last Updated: 2023-10-16
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
50 participants
OBSERVATIONAL
2023-11-10
2024-08-30
Brief Summary
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Detailed Description
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The Lumella test is based on the novel biomarker GlyFn. The company states that compared with other currently used biomarkers (such as soluble fms-like tyrosine kinase-1 \[sfIT-1\] and placental growth factor \[PlGF\] or PlGF alone), GlyFn is etiological to pre-eclampsia and maintains a linear progression throughout pregnancy. The company also claims that the test offers improved sensitivity and specificity over standard care tests. This would lead to a reduction in false positives and false negatives. The Lumella test requires a finger prick blood sample (5 microlitres). Other pre-eclampsia tests currently used in the NHS need a phlebotomy blood sample, which can be difficult to collect in some people. The test can also be transported and stored at room temperature. Other tests for pre-eclampsia need to be refrigerated and brought to room temperature before the test can be done. The Lumella test may improve patient experience and allow a more rapid turnaround time for results. The company states that Lumella is currently the only test that can be done within 10 minutes at room temperature.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Women with preeclampsia
women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE.
Lumella finger prick blood test
Finger prick blood test
Interventions
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Lumella finger prick blood test
Finger prick blood test
Eligibility Criteria
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Inclusion Criteria
* Can give informed consent
* Has symptoms of Preeclampsia
Exclusion Criteria
* Does not want to participate
FEMALE
No
Sponsors
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Croydon University Hospital
OTHER
Responsible Party
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Bini Ajay
Consultant Obstetrician and Gynaecologist
Principal Investigators
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Bini Ajay
Role: PRINCIPAL_INVESTIGATOR
Croydon University Hospital
Locations
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Croydon University Hospital
Croydon, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Huhn et al. BMC Pregnancy and Childbirth (2020) 20:128 https://doi.org/10.1186/s12884-020-2809-2
AM J Obstet Gynecol 2015;212:82.e1-9 Maternal Serum glycosylated fibronectin as a point-of-care biomarker for assessment of preeclampsia
Other Identifiers
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329116
Identifier Type: -
Identifier Source: org_study_id
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