EASL: European Registry of Liver Disease in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall maternal and fetal health during pregnancy and post-delivery in females with liver disease
研究概览
简要总结
Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts. Moreover, the population prevalence of these diseases is low and to-date, it has proven difficult to generate reliable data at a patient level.
This is a multi-center, prospective cohort study that will open at 3 centers within the UK; and 4 centers in the European Union. The investigators will aim to collect data and blood samples at various time points, for patients presenting with liver disease during pregnancy. The main rationale behind this study is to establish a platform that enables detailed review of the outcomes of these rare diseases; to help classify and stratify patients according to risk and develop interventional studies and care pathways to improve overall outcome.
详细描述
The objectives of the study are as follows:
Primary Objective:
To determine the characteristic physiological and biological changes exhibited by females who develop the following liver diseases during pregnancy.
- Acute fatty liver of pregnancy
- Severe cholestasis of pregnancy
- Severe HELLP syndrome/hypertensive disease
- Pre-existing cirrhosis and pregnancy This will be determined through analysis of the standard of care imaging (Liver Ultrasound and Transient Elastography) and blood results (liver function tests, white blood cells, platelets and scoring systems for assessing the severity of liver disease (ALBI, APRI, FIB4 and ELF scores). These results will be analysed over the course of the participant's pregnancy and again at delivery, to explore any particularly distinguishing parameter changes for each disease group.
Secondary Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 18 years of age, willing and able to sign written informed consent.
- •Pregnant and presenting with any one of the following conditions (confirmed by local diagnosis):
- •Acute fatty liver of pregnancy
- •Severe cholestasis of pregnancy
- •Severe HELLP syndrome /hypertensive disease
- •Pre-existing cirrhosis and pregnancy
- •Able to provide written informed consent
- •Willing to provide access to records to necessary data can be collected.
- •Willing to complete additional quality of life questionnaires as per protocol.
- •Willing to consider donation of optional blood samples as per protocol.
排除标准
- •Unable to provide written informed consent
结局指标
主要结局
Overall maternal and fetal health during pregnancy and post-delivery in females with liver disease
时间窗: Data to be collected from pre-pregnancy to 3 months post-delivery
Data from 100 patients will be collected across the EU who have either pre-exisiting cirrhosis or one of the three pregnancy-associated liver diseases that are to be studied in this protocol (AFLP, HELLP, ICP)
次要结局
未报告次要终点