RecruitingNCT05786235

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Sponsor

IRCCS San Raffaele

Enrollment

60 participants

Start Date

Dec 6, 2022

Study Type

OBSERVATIONAL

Conditions

Pregnancy Complications Preeclampsia Pregnancy, High Risk Rheumatic Diseases Immunologic Disease Antiphospholipid Antibody Syndrome Primary

Summary

The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is observing pregnant women who have a condition called antiphospholipid syndrome (APS) — an immune disorder where the blood is more likely to clot — to learn how this condition affects pregnancy outcomes. A healthy pregnant comparison group is also being enrolled. **You may be eligible if...** - You are pregnant and between 18 and 45 years old - You have a confirmed diagnosis of primary antiphospholipid syndrome (APS) - OR you are pregnant with no APS diagnosis and have had at least one previous full-term pregnancy (comparison group) **You may NOT be eligible if...** - Your pregnancy was achieved through assisted reproduction (IVF) - You have chronic high blood pressure or certain neurological conditions - You have had a previous blood clot (thrombosis) - You have chronic kidney failure unrelated to APS - You have a personal history of cancer - You have had multiple previous miscarriages or late pregnancy complications (comparison group only) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCollection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Patients will be enrolled in the study during the first trimester of gestation or later, if the diagnosis of APS is made during pregnancy followed by clinical practice. During the quarterly visits scheduled by clinical practice, the following will be collected relevant clinical information and the additional biological samples for analysis of serum levels of sFlt-1 and PlGF. A follow-up postpartum visit is scheduled by clinical practice at 6 weeks after completion of delivery.

OTHERCollection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Patients will be enrolled during the performance of prenatal diagnosis, routinely chosen by the patient, at which the relevant clinical information and the additional biological sample . Collection of biological material in the 2nd and 3rd TM of gestation will take place at occasion of the routinely scheduled ultrasound scans . A postpartum follow-up visit is scheduled by clinical practice at 6 weeks after the completion of delivery.