Immunomodulation During Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUnidade Local de Saúde de Coimbra, EPE
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Healthy pregnancies
Trial outcomes
Primary outcomes
1
Evaluate the effect of Low dose aspirin (LDA) on the modulation of immunity cells
innate immunity cells and/or acquired immunity
Time frame
30 weeks2
Th1, Th2, Treg, Th17, and Th1/17
Absolute and relative frequencies in total lymphocytes (LY, x10⁹/L; %)
Time frame
30 weeksSecondary outcomes
1
Maternal outcomes
Maternal Complications: Gestational diabetes, gestational hypertension, preterm birth
Time frame
30 weeks2
Maternal outcomes
Weeks of Delivery
Time frame
30 weeks3
Maternal outcomes
Type of delivery (vaginal or cesarean section)
Time frame
30 weeksOther outcomes
1
Fetal Complications
Preterm birth Neonatal intensive care unit
Time frame
30 weeksSponsors and contacts
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Source ClinicalTrials.gov