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Clinical Trials/NCT05786235
NCT05786235
Recruiting
Not Applicable

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

IRCCS San Raffaele1 site in 1 country60 target enrollmentDecember 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
IRCCS San Raffaele
Enrollment
60
Locations
1
Primary Endpoint
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy
Status
Recruiting
Last Updated
10 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 6, 2022
End Date
June 6, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rovere Querini Patrizia

Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital

IRCCS San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Pregnant patients between the ages of 18 and 45 years.
  • Diagnosis of primary APS, according to international classification criteria.
  • 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

  • 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
  • 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

Outcomes

Primary Outcomes

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 Sites (1)

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