Aspirin and Neutrophils in Preeclampsia

NCT04974892 | Completed

• 1 other identifier: IRAS 294761
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Those who respond to LDA and do not develop preeclampsia (responders)
2. 2.Participants who do not respond to LDA and develop preeclampsia (non responders)

Conditions

Preeclampsia; Neutrophil; Immunology; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

low dose aspirin

high-risk women given LDA at ≤16 weeks.

Diagnostic Test: Blood test

Non responders to low dose aspirin

high-risk women who have not responded to LDA and have gone on to develop PE.

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

Blood tests will be taken at 12, 20, 28 and 36 weeks gestation to assess the immune profile and omic profile.

Non responders to low dose aspirin; low dose aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at high risk of developing preeclampsia in pregnancy who are started on low dose aspirin at ≤16 weeks.

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to give consent
• Participants who are unable to understand written English

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust, The Royal London Hospital

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: July 23, 2021
• Study Start: April 27, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)