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临床试验/CTRI/2024/09/074219
CTRI/2024/09/074219尚未招募不适用

Validation of performance of multiparametric risk prediction models for preeclampsia in early pregnancy and determination of the best fit model for Indian Population

All India Institute of Medical Sciences New Delhi2 个研究点 分布在 1 个国家目标入组 1,139 人开始时间: 2024年9月25日最近更新:

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

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

K Aparna Sharma

All India Institute of Medical Sciences, New Delhi

研究点 (2)

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