Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

IRCCS San Raffaele60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

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

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.

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

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Group 1 1. Pregnant patients between the ages of 18 and 45 years. 2. Diagnosis of primary APS, according to international classification criteria. * Group 2 1. Pregnant patients between the ages of 18 and 45 years. 2. Patients with at least one previous full-term pregnancy. 3. No diagnosis of APS, according to international classification criteria. Exclusion Criteria: * Group 1 1. PMA pregnancies. 2. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology 3. Previous thrombotic event 4. Chronic renal failure not related to AD 5. Previous history of oncology * Group 2 1. Pregnancy by PMA. 2. Previous history of polyabortion and/or late pregnancy complications. 3. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology 4. Previous thrombotic event 5. Previous history of oncology

Outcomes

Primary Outcomes

To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy

To construct reference ranges of placental angiogenesis markers specific to women with 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).

Time frame: six month after the end of the study

Central Contacts

Patrizia Rovere Querini

CONTACT

+390226436095 rovere.patrizia@hsr.it

Valentina Canti