CTRI/2025/08/093346尚未招募不适用
A Prospective Multicentric Performance Evaluation study for a rapid Preeclampsia screening test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- To evaluate the Diagnostic Accuracy of the Preeclampsia screening test
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 having gestational age between 11 to 16 weeks from LMP and/or CRL.
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 Participation in another drug trial within 28 days before screening Pregnant women diagnosed with Preeclampsia Pregnant women who are already on aspirin medication Pregnant women with a known case of diabetes or chronic HTN Twins or multiple pregnancies.
结局指标
主要结局
To evaluate the Diagnostic Accuracy of the Preeclampsia screening test
时间窗: At 6 time points of testing during the study (gestational age) | 1. 11 to 12 weeks ± 6 days | 2. 13 to 15 weeks ± 6 days | 3. 16 to 19 weeks ± 6 days | 4. 20 to 28 weeks ± 6 days | 5. 28 to 34 weeks ± 6 days | 6. after 35 weeks ± 0 days
次要结局
- Using patient history and other clinical findings (MAP, USG findings, maternal factors) and combinations for enhanced diagnostic accuracy(6 time points)
- Association of risk factors with Preeclampsia(6 time points)
研究者
Dr Amitabha Bandyopadhyay
IIT Kanpur
研究点 (2)
Loading locations...
相似试验
尚未招募
1 期
Pharmacokinetic Study to Evaluate Safety and Tolerability of EG-101 in Healthy Female Volunteers as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsiaPre-eclampsiaNCT07327255Evergreen Therapeutics, Inc.24
招募中
不适用
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second TrimestersPreeclampsia (PE)NCT06716242iPremom7,473
尚未招募
不适用
Assessment of maternal cardiac dysfunction using 2D echo in preeclampsia- one year observational study at KLES Prabhakar Kore hospitalCTRI/2025/12/098386Vagisha Singh72
尚未招募
不适用
fullPIERS Model in the Prediction of Adverse Maternal Outcomes in PreeclampsiaNCT07316140Sohag University50
尚未招募
不适用
Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With PreeclampsiaNCT07384936Fang Wang100