Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID06882850

Immunomodulation During Pregnancy Through Low-Dose Aspirin: a Hypothetical Mechanism for the Prevention of Preeclampsia?

Led by Unidade Local de Saúde de Coimbra, EPE · Updated on 2025-03-19

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Immunomodulation During Pregnancy

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women with a single baby
  • Attending prenatal consultations before 14 weeks of pregnancy
  • Gestational age confirmed by first-trimester ultrasound
  • Classified as high risk for preeclampsia using clinical and algorithm criteria
  • Not yet started low dose aspirin during this pregnancy
Not Eligible

You will not qualify if you...

  • Multiple pregnancy
  • Autoimmune diseases
  • Prior use of low dose aspirin or other immunomodulatory drugs before enrollment
  • History of multiple miscarriages or medical pregnancy termination
  • Fetal malformations detected before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Monitoring

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

Monitoring

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

Trial Site Locations

Total: 1 location

1

Unidade Local de Saúde de Coimbra, E.P.E.

Coimbra, Coimbra District, Portugal, 3000-075

Actively Recruiting

Loading map...

Research Team

A

Ana L Areia, PhD, MD

J

João Sargento-Freitas, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

A Prospective Cohort Study on the Dynamic Monitoring of Seru...

Polycystic Ovary Syndrome

Actively Recruiting

1 location

Assessing Pharmacokinetics and Pharmacodynamics of Daily Ent...

Platelet Aggregation

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial