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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05786235
Other study ID # APS_FLT1/PLGF
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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