Validation of performance of multiparametric risk prediction models for preeclampsia in early pregnancy and determination of the best fit model for Indian Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,139
- 试验地点
- 2
- 主要终点
- Pre-eclampsia
研究概览
简要总结
Preeclampsia occurs in 2–8% of pregnancies worldwide and is the second leading cause of direct maternal and fetal deaths. In India, the reported incidence of eclampsia varies from 0.17 to 3.7% and maternal mortality of eclamptic women varies from 2.2% to 23%. The early detection of the risk of this complication may allow for the improvement of the maternal and fetal outcome by increasing patient surveillance or by initiating a therapeutic intervention. The current prediction model used across the globe, especially in the UK, is a multiparametric test involving biophysical and biomarkers to predict the occurrence of preeclampsia. There is a concern that the implementation of the screening protocols may require local modification and the estimate of performance from the literature may not be applicable to all populations. Thus, it is important to evaluate the performance of various multiparametric tests for screening of preeclampsia in the Indian population and validate the same.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •More than 14 weeks of pregnancy Willing to be a part of the study.
排除标准
- •women not willing to give consent.
结局指标
主要结局
Pre-eclampsia
时间窗: At 20 weeks or more period of gestation
次要结局
- 1. To evaluate the performance of maternal history-based prediction models (in the Indian population(2) To calibrate the risk prediction model for selecting the high-risk group that could benefit from the prophylactic use of aspirin in the Indian population for singleton pregnancies)
研究者
K Aparna Sharma
All India Institute of Medical Sciences, New Delhi
