Immunomodulation During Pregnancy

NCT06882850 | Recruiting DMC

• 1 other identifier: OBS.SF.160/2022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 question it aims to answer is: 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, Th cells). Participants already taking intervention A as part of their regular medical care for RA will answer online survey questions about their joint pain for 5 years.

Conditions

Aspirin; Pregnancy Complications; Immunology

Keywords

Immunology; Pregnancy; Aspirin; Lymphocytes; T-Lymphocytes

Outcome Measures

Primary Outcomes (2)

• Evaluate the effect of Low dose aspirin (LDA) on the modulation of immunity cells

  innate immunity cells and/or acquired immunity

  30 weeks

• Th1, Th2, Treg, Th17, and Th1/17

  Absolute and relative frequencies in total lymphocytes (LY, x10⁹/L; %)

  30 weeks

Secondary Outcomes (3)

• Maternal outcomes

  30 weeks

• Maternal outcomes

  30 weeks

• Maternal outcomes

  30 weeks

Other Outcomes (1)

• Fetal Complications

  30 weeks

Study Arms (1)

Healthy pregnancies

High-risk preeclampsia pregnencies

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women attending routine low-risk prenatal consultations at the Department of Obstetrics of the Centro Hospitalar Universitário de Coimbra (CHUC). A written procedure detailing the research and the general objectives of the proposal will be submitted to the hospital's ethics committee for approval. Informed consent from patients will be obtained under strict ethical protocols.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

Study Sites (1)

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

Coimbra, Coimbra District, 3000-075, Portugal

RECRUITING

Related Publications (2)

• 1. Cadavid AP. Aspirin: The Mechanism of Action Revisited in the Context of Pregnancy Complications. Front Immunol. 2017;8:261. 2. Mittelberger J, Seefried M, Franitza M, Garrido F, Ditsch N, Jeschke U, et al. The Role of the Immune Checkpoint Molecules PD-1/PD-L1 and TIM-3/Gal-9 in the Pathogenesis of Preeclampsia-A Narrative Review. Medicina (Kaunas). 2022;58(2). 3. Khanabdali R, Shakouri-Motlagh A, Wilkinson S, Murthi P, Georgiou HM, Brennecke SP, et al. Low-dose aspirin treatment enhances the adhesion of preeclamptic decidual mesenchymal stem/stromal cells and reduces their production of pro-inflammatory cytokines. J Mol Med (Berl). 2018;96(11):1215-1225. 4. Panagodage S, Yong HE, Da Silva Costa F, Borg AJ, Kalionis B, Brennecke SP, et al. Low-Dose Acetylsalicylic Acid Treatment Modulates the Production of Cytokines and Improves Trophoblast Function in an in Vitro Model of Early-Onset Preeclampsia. Am J Pathol. 2016;186(12):3217-3224. 5. Robillard PY, Dekker G, Scioscia M, Saito S. Progress in the understanding of the pathophysiology of immunologic maladaptation related to early-onset preeclampsia and metabolic syndrome related to late-onset preeclampsia. Am J Obstet Gynecol. 2022;226(2S):S867-S875. 6. Brox R, Hackstein H. Physiologically relevant aspirin concentrations trigger immunostimulatory cytokine production by human leukocytes. PLoS One. 2021;16(8):e0254606. 7. Dong W, Yin L. Expression of lipoxin A4, TNFalpha and IL-1beta in maternal peripheral blood, umbilical cord blood and placenta, and their significance in pre-eclampsia. Hypertens Pregnancy. 2014;33(4):449-456. 8. Tung YT, Wei CH, Yen CC, Lee PY, Ware LB, Huang HE, et al. Aspirin Attenuates Hyperoxia-Induced Acute Respiratory Distress Syndrome (ARDS) by Suppressing Pulmonary Inflammation via the NF-kappaB Signaling Pathway. Front Pharmacol. 2021;12:793107. 9. Dong W, Liu X, Liu W, Wang C, Zhao S, Wen S, et al. Dual antiplatelet therapy improves functional recovery and inhibits inflammation after ce

  BACKGROUND

• Areia AL, Almeida J, Alves V, Mota-Pinto A, Sa H. Modulation of Immune Cells by Aspirin During Pregnancy. Immunology. 2026 Feb;177(2):329-338. doi: 10.1111/imm.70051. Epub 2025 Oct 14.

  PMID: 41087834 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ana L Areia, PhD MD

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana L Areia, PhD, MD

CONTACT

+351917212222; analuisareia@gmail.com

João Sargento-Freitas, PhD

CONTACT

+351239400488; joaosargentofreitas@ulscoimbra.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 19, 2025
• Study Start: February 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From My 2025 to May 2030

Locations

PT (1)