Меню
Идёт набор NCT05786235

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

— Наблюдательное Preeclampsia Immunologic Disease Antiphospholipid Antibody Syndrome Primary Pregnancy Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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).
Кому может быть актуально
Состояния в реестре: Preeclampsia, Immunologic Disease, Antiphospholipid Antibody Syndrome Primary, Pregnancy Complications. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 1 центр
  • San Raffaele Hospital — Milan

Идентификаторы

NCT: NCT05786235 · APS_FLT1/PLGF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗