跳至主要内容
临床试验/NCT04221048
NCT04221048已完成不适用

Accuracy of Risk Prediction Scores in Pregnant Women With Congenital Heart Disease.

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Number of Cardiovascular complications

研究概览

简要总结

Management of pregnancy and risk stratification in congenital heart disease (CHD) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. We aim to compare the accuracy of the main published scores including CARPREG II score in prediction of maternal complications during pregnancy in CHD patients.

详细描述

Since the end of the 20th century, surgical and medical care progresses have significantly improved prognosis and quality of life of patients with congenital heart diseases (CHD). Currently, women with CHD expect to experience a "normal" life and express a strong maternity desire.

During the last decade, several scores have been used to predict outcome of pregnancy in women with cardiovascular heart diseases. It has been suggested that the mWHO classification was more appropriate than the previous ones (e.g. Harris, Zahara and CAPREG classifications) in predicting cardiac complications in CHD. More recently, a new risk score stratification (CARPREG II) have been published to improve maternal risk stratification.

This retrospective study will include all pregnant women with CHD who were follow up in our institution from January 2007 to June 2018 until 6 months postpartum. The investigators will collect demographic and clinical data, type and complexity of CHD (Houyel and Bethesda classification), and pregnancy outcomes. Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes. The discriminatory power of each risk scores was assessed by the area-under-the receiver-operating characteristic (ROC) curve (AUC). In order to assess the reproducibility of scores classification assigned to CHD patients, all pregnancy scores from this cohort were assessed by 3 independent observers and, thereafter, estimated Cronbach's coefficient alpha.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Cardiovascular complications

时间窗: From the 20th week of gestation until 6 months post partum

Cardiovascular complications during pregnancy until 6 months post partum

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验