Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 主要终点
- Primary outcome a 25% or greater decline in eGFR between six weeks and 12 months postpartum or initiation of dialysis
研究概览
简要总结
To develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study.
详细描述
The aim of this study is to develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study. Two prediction models will be developed to estimate the likelihood of both outcomes. The models will be developed and internally validated in one cohort in the United Kingdom and then externally validated using four international datasets.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with an estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) without ethnicity adjustment, less than 90mls/min/1.73m2 within 24 months pre-conception will be included
排除标准
- •Women established on dialysis at time of conception
- •Multi-fetal pregnancies
- •Known inpatient eGFR measurement
- •No preconception eGFR within 24 months will be excluded.
结局指标
主要结局
Primary outcome a 25% or greater decline in eGFR between six weeks and 12 months postpartum or initiation of dialysis
时间窗: Six weeks to 12 months postpartum
A \>=25% reduction in eGFR between six weeks and 12 months postpartum or initiation of dialysis.
次要结局
- Secondary outcome: a preterm birth less than 34 weeks or small for gestational age less than 3rd percentile.(To be recorded within 24 hours of date of delivery (Index event is the day of delivery). This outcome is measured on date of delivery.)