Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia
Lumella
Lumella is a Point of Care Blood Test Used Together With Other Blood Tests to Assess the Risk of Preeclampsia in Pregnancy in 10 Minutes. Measurements of the Biomarker.
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedStudy Start
First participant enrolled
November 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedOctober 16, 2023
October 1, 2023
7 months
October 11, 2023
October 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
can we use a bedside test -glycosylated fibronectin for the early diagnosis of pre-eclampsia
Does the test work?
6 months
Secondary Outcomes (1)
Is glycosylated fibronectin better than placental growth factor or traditional blood tests
6 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Pregnant Women
You may qualify if:
- If they can speak English
- Can give informed consent
- Has symptoms of Preeclampsia
You may not qualify if:
- Can't speak English
- Does not want to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Croydon University Hospital
Croydon, Surrey, CR7 7YE, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bini Ajay
Croydon University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Obstetrician and Gynaecologist
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 16, 2023
Study Start
November 10, 2023
Primary Completion
May 30, 2024
Study Completion
August 30, 2024
Last Updated
October 16, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
Not sharing identifiable data