Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT05786235

Run by

IRCCS San Raffaele

People needed

60

Starts

2022-12-06

Expected to finish

2026-06-06

Last updated by the study team

2025-06-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• San Raffaele Hospital — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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