Effects of low dose aspirin on immunity during pregnancy
Immunomodulation During Pregnancy Through Low-Dose Aspirin: a Hypothetical Mechanism for the Prevention of Preeclampsia?
This study is testing how low dose aspirin affects the immune system in pregnant women who are at high risk for preeclampsia to see if it helps improve their health and the health of their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Unidade Local de Saúde de Coimbra, EPE Academic / other |
| Locations | 1 site (Coimbra, Coimbra District) |
| Trial ID | NCT06882850 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how low dose aspirin (LDA) affects the immune system in pregnant women at high risk for preeclampsia (PE). It will assess the modulation of various immune cells and quantify pro-inflammatory and anti-inflammatory cytokines before and after LDA administration. The study will include singleton pregnancies monitored at the Centro Hospitalar e Universitário de Coimbra, with participants classified as high-risk for PE based on specific clinical criteria. The study will last between 40 weeks and 24 months, focusing on maternal and fetal outcomes in comparison to low-risk pregnancies.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with singleton pregnancies classified as high risk for preeclampsia who have not previously taken low dose aspirin.
Not a fit: Patients with multiple pregnancies, autoimmune diseases, or a history of spontaneous miscarriages may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how low dose aspirin may improve immune responses and pregnancy outcomes for women at risk of preeclampsia.
How similar studies have performed: While this approach is observational and builds on existing knowledge of aspirin's effects, similar studies have shown promising results in understanding the immunological impacts of aspirin during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Singleton pregnancy * Patients attending prenatal consultations at the Obstetrics Service A of CHUC, with the first consultation occurring before 14 weeks of gestation * Gestational age determined by first-trimester ultrasound * Study group: Women classified as high risk for PE according to clinical/historical criteria and the Fetal Medicine Foundation algorithm. LDA-naïve. Exclusion Criteria: Multiple pregnancy * Autoimmune diseases * Prior use of LDA or other immunomodulatory medication before potential recruitment * History of spontaneous miscarriages and/or medical termination of pregnancy * Fetal malformation
Where this trial is running
Coimbra, Coimbra District
- Unidade Local de Saúde de Coimbra, E.P.E. — Coimbra, Coimbra District, Portugal (Recruiting)
Study contacts
- Principal investigator: Ana L Areia, PhD MD — University of Coimbra
- Study coordinator: Ana L Areia, PhD, MD
- Email: analuisareia@gmail.com
- Phone: +351917212222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.