Modulation of Immune Cells by Aspirin During Pregnancy.
Ana Luísa Areia, Jani Almeida, Vera Alves...
https://pubmed.ncbi.nlm.nih.gov/41087834Actively Recruiting
Led by Unidade Local de Saúde de Coimbra, EPE · Updated on 2025-03-19
30
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to understand how low dose aspirin (LDA) affects immune cells during pregnancy, focusing on women at high risk for preeclampsia (PE). The study evaluates the impact of LDA on both innate immunity cells like NK cells and monocytes, and acquired immunity cells such as B and T lymphocytes. It also compares immune responses and pregnancy outcomes between women at high risk who receive aspirin and those at low risk who do not. The study is observational and includes 30 pregnant women monitored over at least 40 weeks, up to 24 months. Participants are grouped into high risk for PE, who receive daily 150 mg aspirin starting before 14 weeks gestation, and low risk who do not take aspirin. Blood samples will be taken during each trimester to analyze immune cell changes and cytokine levels. Additional samples are collected before and after aspirin use in the high-risk group. After delivery, placental tissue and umbilical cord blood will be examined for immune markers. Participants will attend prenatal consultations where blood tests are performed alongside routine care. Researchers will use advanced lab methods to measure immune cells and cytokines. Outcomes include immune cell modulation at 30 weeks and maternal health measures. The study also examines placental tissue after birth. This trial is led by Unidade Local de Saúde de Coimbra, EPE, and participation involves regular pregnancy monitoring with added blood collections and assessments.
CONDITIONS
Immunomodulation During Pregnancy
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 weeks (duration of pregnancy)
Participants have peripheral blood samples collected during routine pregnancy blood draws at the 1st, 2nd, and 3rd trimesters to evaluate immune cell fluctuations and cytokine levels.
3 visits coinciding with routine prenatal blood draws
Duration - At least 4 weeks after beginning aspirin
High-risk participants receive low-dose aspirin and have additional blood samples collected before starting aspirin and four weeks afterwards to evaluate immune modulation.
2 additional visits for blood sampling
Duration - Post-delivery period
After delivery, participants undergo placental histopathological evaluation and umbilical cord blood analysis to assess immune cells and cytokine markers.
1 visit after delivery
Total: 1 location
1
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, Coimbra District, Portugal, 3000-075
Actively Recruiting
A
Ana L Areia, PhD, MD
J
João Sargento-Freitas, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Ana Luísa Areia, Jani Almeida, Vera Alves...
https://pubmed.ncbi.nlm.nih.gov/41087834