临床试验/CTRI/2025/08/093428

CTRI/2025/08/093428尚未招募不适用

A prospective longitudinal cohort study for Preeclampsia screening during pregnancy using a rapid test

Intignus Biotech Pvt Ltd1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2025年9月1日最近更新: 2025年8月21日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 200
试验地点: 1
主要终点: Sensitivity and specificity of PEscreen in identifying women at risk of developing Preeclampsia compared to standard care of screening method

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Preeclampsia (PE) is a potentially fatal condition affecting pregnant women and the fetus during pregnancy and/or postpartum. An ability to predict and determine preeclampsia risk will change the way doctors manage the disease and help improve health outcomes for both the mother and the baby.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 50.00 Year(s)（—）
性别: Female

入选标准

•Pregnant women.

排除标准

•Unconscious or severely ill status
•Having major fetal abnormality identified at the time of enrollment
•Known bleeding disorder such as von Willebrand’s disease
•Pregnant women diagnosed with Preeclampsia.

结局指标

主要结局

Sensitivity and specificity of PEscreen in identifying women at risk of developing Preeclampsia compared to standard care of screening method

时间窗: 4 time points

次要结局

Using patient history and other clinical findings (MAP, USG findings, maternal factors) and combinations for enhanced diagnostic accuracy(4 time points)
Association of risk factors with Preeclampsia(4 time points)
Improved awareness among pregnant women surrounding topics of high risk pregnancies and preeclampsia(4 time points)

研究者

发起方

Intignus Biotech Pvt Ltd

申办方类型

Other [A private limited biotech company]

责任方

Principal Investigator

主要研究者

Dr Abhijit Ambike

Symbiosis University Hospital and Research Centre

研究点 (1)

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