Status:

RECRUITING

Immunomodulation During Pregnancy

Lead Sponsor:

Unidade Local de Saúde de Coimbra, EPE

Conditions:

Aspirin

Pregnancy Complications

Eligibility:

FEMALE

18+ years

Brief Summary

The goal of this observational study is to learn about the effects of low dose aspirin in immunity Pregnant women taking aspirin for other reasons (preeclampsia prevention) will be studied. The main q...

Detailed Description

The main objective of this study is to evaluate the effect of LDA on the modulation of innate immunity cells (NK cells, monocytes, γδ T cells) and/or acquired immunity (B and T lymphocytes, Treg cells...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 31 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06882850

Start Date

February 1 2024

End Date

March 31 2025

Last Update

March 19 2025

Active Locations (1)

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

Coimbra, Coimbra District, Portugal, 3000-075