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NCT Number: NCT05786235

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

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.

Recruiting

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Key information

Conditions

Preeclampsia Antiphospholipid Antibody Syndrome Primary Connective Tissue Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Immune System Diseases Immunologic Disease Musculoskeletal Diseases Pre-Eclampsia Pregnancy Complications Pregnancy, High Risk Rheumatic Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Other

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.

Primary outcomes

  1. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Rovere Querini

CONTACT

[email protected]

+390226436095

Valentina Canti

CONTACT

[email protected]

+390226436095

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 27, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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