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Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

NCT05786235 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-06-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2025-12-06
Completion
2026-06-06

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786235 on ClinicalTrials.gov