Идёт набор NCT07148115

Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

— Наблюдательное Pregnancy Complications SLE

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: Collect data on all pregnancies before and after diagnosis of SLE..
Кому может быть актуально: Состояния в реестре: Pregnancy Complications, SLE. Базовые параметры: 18 лет — 55 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: Algeria
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis

Обзор

This is an observational, monocentric, retrospective cohort study. Its primary objective is to examine maternal and foetal outcomes in pregnancies that occurred before the diagnosis of systemic lupus erythematosus (SLE) in a group of female participants who were subsequently diagnosed with the condition.

Подробное описание

The investigators aim to study obstetrical and systemic signs in participants' pregnancies prior to an SLE diagnosis. Information will be collected from medical records and by asking participants questions during medical visits. The diagnosis of SLE is made using the ACR 1997 criteria. It is also based on renal histological findings.

The study must answer three questions:

1. Are systemic signs of SLE present before or during pregnancy? 2. What were the fetal and maternal outcomes after or during each pregnancy? What is/was the severity of SLE after diagnosis?

Вмешательства

Другое Collect data on all pregnancies before and after diagnosis of SLE.
For participants who are still alive, data are collected from interviews with patients using a prepared questionnaire that asks about all pregnancies and obstetrical events prior to the diagnosis of SLE. For deceased patients, data are taken from the medical records of obstetrical events. Data will be collected on anthropometric, biological, immunological, and histological features before and after the diagnosis of SLE, if available. The activity and severity of the disease after diagnosis wi

Первичные конечные точки

1. Primary outcome: Prevalence of obstetrical events before the diagnosis of SLE. Secondary outcome: 1. Assess the severity of the disease at the time of LES diagnosis. 2. Compare the outcomes of pregnancies before and after the LES [Срок оценки: The patient will be assessed from the beginning of each pregnancy and in the three month after childbirth]

Критерии участия

Критерии включения

Women of childbearing age with a history of at least one pregnancy
Pregnancy occurred before the diagnosis of LES.
LES was diagnosed after at least one pregnancy.
The subject is classified as having LES according to the 1997 ACR or EULAR 2019 criteria.