Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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:
- Are systemic signs of SLE present before or during pregnancy?
- What were the fetal and maternal outcomes after or during each pregnancy? What is/was the severity of SLE after diagnosis?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Femelle patients at procreation age with diagnosis of LES
Patients that have had pregnancies history before the diagnosis of LES
干预措施: Collect data on all pregnancies before and after diagnosis of SLE. (Other)
结局指标
主要结局
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
时间窗: The patient will be assessed from the beginning of each pregnancy and in the three month after childbirth
* Evaluate the number of pregnancies for each woman before and after the diagnosis of lupus. * Assess obstetric events for each pregnancy (spontaneous abortion, prematurity, fetal death, pre-eclampsia, HELLP syndrome, or other pregnancy-related events). * Assess the presence of systemic signs during pregnancy or the postpartum period. * Collect data on the baby's status, including weight, height, and any morbid conditions (dermatological, cardiac, respiratory, etc.). * Note the timeframe between the last pregnancy or delivery and the SLE diagnosis.
次要结局
未报告次要终点
研究者
W.N. Nibouche-Hattab
Professor of Medicine
University of Algiers