Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Preeclampsia Clinical Trial

Official title:

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786235
• Other study ID #: APS_FLT1/PLGF
• Status: Recruiting
• Start date: December 6, 2022
• Est. completion date: June 6, 2026

Study information

• Verified date: March 2023
• Source: IRCCS San Raffaele
• Contact: Patrizia Rovere Querini
• Phone: +390226436095
• Email: rovere.patrizia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 6, 2026
• Est. primary completion date: December 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Collagen Diseases
• Immune System Diseases
• Immunologic Disease
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications
• Pregnancy, High Risk
• Rheumatic Diseases
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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