Pregnancy Clinical Trial
Official title:
Investigating the Role of Neutrophils in Aspirin Treatment for Women at High Risk of Preeclampsia
Verified date | February 2024 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The exact mechanisms by which aspirin prevents the development of preeclampsia in high-risk patients are currently not fully known. Furthermore, a small proportion of high-risk patients who are on low-dose aspirin (LDA) still go on to develop preeclampsia (PE). This longitudinal observational study will assess the immune profile in participants who are taking low dose aspirin (LDA) in pregnancy. As part of routine care, patients at high risk of developing preeclampsia are treated with LDA from 16 weeks gestation. The study will be conducted at Barts Health National Health Service (NHS) Trust. The study population will comprise of 2 groups of participants: 1. Those who respond to LDA and do not develop preeclampsia (responders) 2. Participants who do not respond to LDA and develop preeclampsia (non responders) Participants will be consented at their booking appointment. Participants will be eligible if they have a singleton pregnancy and are aged over 18 years. They will have an additional blood sample taken at 12, 20, 28 and 36 weeks gestation. The blood samples will be tested to assess immune cell function, metabolism and genetics. This will identify cumulative changes in immunobiology at key time points in pregnancy.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | April 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion criteria - Age 18-60 years - Singleton pregnancy - Live fetus at 11-13 weeks of gestation - Informed, written consent - Upper age of 60 years - Patient taking low dose aspirin as standard of care Exclusion criteria - Unwilling or unable to give consent - Participants who are unable to understand written English |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barts Health NHS Trust, The Royal London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To longitudinally define the neutrophil profile in high-risk patients given low dose aspirin (LDA) at =16 weeks. | To address the first objective, to assess the neutrophil profile in high-risk patients given LDA at =16 weeks, a longitudinal analyses will be undertaken of neutrophils taken from participants at high-risk of PE (as identified at their pregnancy booking appointment). The first blood test will occur prior to aspirin commencement and be repeated at 3 other time points in pregnancy. These longitudinal analyses will identify cumulative changes in neutrophils following the commencement of aspirin treatment and pinpoint key timepoints of aspirin on neutrophil biology. | 2 years | |
Primary | To define the neutrophil profile in a cohort of high-risk patients who have not responded to low dose aspirin (LDA) and have gone on to develop PE. | To address the second objective (to assess the neutrophil profile in a cohort of high-risk patients who have not responded to LDA and have gone on to develop PE), 20 LDA non-responders subsequently develop PE will be identified. | 2 years |
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