Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Recruiting

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

• Registration Number: NCT05786235
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-06
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-27
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30
• Primary Completion: 2025-12-06
• Study Completion: 2026-06-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant patients with primary APS	Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)	Diagnosis of primary APS, according to international classification criteria
pregnant patients who do not have APS	Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)	Patients with at least one previous full-term pregnancy No diagnosis of APS, according to international classification criteria

Primary Outcome Measures

Name	Time	Method
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy	six month after the end of the study	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).

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy