Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Diseases; Pregnancy Complications; Pregnancy, High Risk; Preeclampsia; Immunologic Disease; Antiphospholipid Antibody Syndrome Primary
• Intervention / Treatment: Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood); Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Patrizia Rovere Querini; Phone Number: +390226436095; Email: rovere.patrizia@hsr.it
• Study Contact Backup: Name: Valentina Canti; Phone Number: +390226436095; Email: canti.valentina@hsr.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • San Raffaele Hospital
    • Contact: Patrizia Rovere Querini, PhD,MD; Phone Number: +390226433065; Email: rovere.patrizia@hsr.it
    • Contact: Valentina Canti, MD; Phone Number: +390226436095; Email: canti.valentina@hsr.it
    • Sub-Investigator: Valentina Canti, MD
    • Principal Investigator: Paolo Cavoretto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.; 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.
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); 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Anticipated): December 6, 2025
• Study Completion (Anticipated): June 6, 2026

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Autoimmune Diseases; Disease; Musculoskeletal Diseases; Connective Tissue Diseases; Hypertension, Pregnancy-Induced; Syndrome; Rheumatic Diseases; Collagen Diseases; Pre-Eclampsia; Pregnancy Complications; Immune System Diseases; Antiphospholipid Syndrome
• Other Study ID Numbers: APS_FLT1/PLGF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No