Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

NCT05786235 | Recruiting

• 1 other identifier: APS_FLT1/PLGF
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  six month after the end of the study

Study Arms (2)

pregnant patients with primary APS

Diagnosis of primary APS, according to international classification criteria

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

pregnant patients who do not have APS

Patients with at least one previous full-term pregnancy No diagnosis of APS, according to international classification criteria

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

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.

pregnant patients with primary APS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

At least 60 patients aged 18-45 years will be enrolled between the first and third trimester of gestation, specifically 40 pregnant patients with primary APS (Group 1) and 20 pregnant patients without APS (Group 2) followed at the outpatient clinics of Obstetrics and Pregnancy Pathology of the participating centers. All patients will be asked to sign an informed consent prior to the collection of data and biological material.

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Immune System Diseases; Pregnancy Complications; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Patrizia Rovere Querini

CONTACT

+390226436095; rovere.patrizia@hsr.it

Valentina Canti

CONTACT

+390226436095; canti.valentina@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: December 6, 2022
• Primary Completion: December 6, 2025
• Study Completion (Estimated): June 6, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

IT (1)