Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
Recruiting · NCT05786235 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)
What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Group 1
- Pregnant patients between the ages of 18 and 45 years.
- Diagnosis of primary APS, according to international classification criteria.
- Group 2
- Pregnant patients between the ages of 18 and 45 years.
- Patients with at least one previous full-term pregnancy.
- No diagnosis of APS, according to international classification criteria.
Exclusion criteria
- Group 1
- PMA pregnancies.
- Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
- Previous thrombotic event
- Chronic renal failure not related to AD
- Previous history of oncology
- Group 2
- Pregnancy by PMA.
- Previous history of polyabortion and/or late pregnancy complications.
- Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
- Previous thrombotic event
- Previous history of oncology
Where it is running
1 location listed.
- San Raffaele Hospital - Milan, Italy