Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

NCT ID: NCT05786235

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-06
• Study Completion Date: 2026-06-06

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

pregnant patients with primary APS

Diagnosis of primary APS, according to international classification criteria

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

Intervention Type: 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 who do not have APS

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

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

Intervention Type: 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.

Interventions

Collection 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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Rovere Querini Patrizia

Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

San Raffaele Hospital

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Patrizia Rovere Querini

Role: CONTACT

rovere.patrizia@hsr.it

+390226436095

Valentina Canti

Role: CONTACT

canti.valentina@hsr.it

+390226436095

Facility Contacts

Patrizia Rovere Querini, PhD,MD

Role: primary

rovere.patrizia@hsr.it

+390226433065

Valentina Canti, MD

Role: backup

canti.valentina@hsr.it

+390226436095

Other Identifiers

APS_FLT1/PLGF

Identifier Type: -

Identifier Source: org_study_id