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Recruiting NCT05786235

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

— Observational Preeclampsia Immunologic Disease Antiphospholipid Antibody Syndrome Primary Pregnancy Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood), Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood).
Who it may be relevant to
Registry conditions: Preeclampsia, Immunologic Disease, Antiphospholipid Antibody Syndrome Primary, Pregnancy Complications. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy [Time frame: six month after the end of the study]

Eligibility criteria

Inclusion criteria

  • Group 1
  • Pregnant patients between the ages of 18 and 45 years.
  • Diagnosis of primary APS, according to international classification criteria.
  • Group 2
  • Pregnant patients between the ages of 18 and 45 years.
  • Patients with at least one previous full-term pregnancy.
  • No diagnosis of APS, according to international classification criteria.

Exclusion criteria

  • Group 1
  • PMA pregnancies.
  • Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  • Previous thrombotic event
  • Chronic renal failure not related to AD
  • Previous history of oncology
  • Group 2
  • Pregnancy by PMA.
  • Previous history of polyabortion and/or late pregnancy complications.
  • Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  • Previous thrombotic event
  • Previous history of oncology

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • San Raffaele Hospital — Milan

Identifiers

NCT: NCT05786235 · APS_FLT1/PLGF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗