Antiphospholipid Antibody Syndrome Primary, Immunologic Disease, Preeclampsia, Pregnancy Complications, Pregnancy, High Risk, Rheumatic Diseases
Conditions
Brief 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.
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.
Sponsors
IRCCS San Raffaele
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy | six month after the end of the study | 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). |
Countries
Italy
Contacts
Primary ContactPatrizia Rovere Querini
Backup ContactValentina Canti
Outcome results
None listed