Third trimester Risk Assessment for Preeclampsia using sFLT-1 Lateral-flow assay (LFA) biomarker test: A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 1.The performance of Gravidas LFA test (Sensitivity, Specificity, PPV and NPV) in predicting severe PE in the suspected preeclampsia population.
研究概览
简要总结
This prospective observational study evaluates the effectiveness of the Gravidas LFA test, a point-of-care diagnostic tool, in predicting severe preeclampsia (sPE) and adverse maternal/perinatal outcomes within two weeks in high-risk pregnant women. The Gravidas LFA, which estimates sFLT-1 levels, is compared to standard clinical indicators and the Roche Elecsys platform’s sFLT-1/PlGF ratio test.
Objectives
- Assess Gravidas LFA’s performance (sensitivity, specificity, PPV, NPV) in predicting sPE.
- Compare Gravidas LFA’s predictive value with that of the sFLT-1/PlGF ratio from standard testing.
Clinical Relevance Current clinical signs (e.g., blood pressure, proteinuria, edema, etc) poorly predict sPE. While sFLT-1/PlGF testing is FDA-approved, it’s not feasible in low-resource settings. Gravidas LFA offers a fast, low-cost, and effective alternative, potentially improving early detection and intervention in underserved areas.
Study Design & Methodology The trial involves 500 third-trimester women with suspected PE. Blood samples will be tested using both Gravidas LFA test and standard Roche Elecsys platforms. Participants will be followed through delivery to document outcomes.
Impact Wider implementation of Gravidas LFA may enhance patient care, reduce healthcare burden, and save maternal & fetal lives in low/middle-income countries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Current singleton pregnancy
- •Gestational age 23 0/7 to 37 0/7 weeks that is confirmed by ultrasound estimation.
- •Women presenting with clinical suspicion of PE (new onset high blood pressure or worsening of chronic hypertension, edema or excess weight gain, proteinuria, headache, abdominal pain, visual symptoms).
排除标准
- •Multiple pregnancy
- •Patient is enrolled in another clinical trial
- •Patients receiving intravenous heparin.
结局指标
主要结局
1.The performance of Gravidas LFA test (Sensitivity, Specificity, PPV and NPV) in predicting severe PE in the suspected preeclampsia population.
时间窗: The collected blood samples will be assessed using the diagnostic tool every 3rd month. And will be cross verified with the adverse maternal & fetal outcome data collected after delivery.
2. The performance (Sensitivity, Specificity, PPV and NPV) of sFLT-1 and PlGF ratio in predicting severe PE in the suspected preeclampsia population.
时间窗: The collected blood samples will be assessed using the diagnostic tool every 3rd month. And will be cross verified with the adverse maternal & fetal outcome data collected after delivery.
次要结局
- 1. The performance of Gravidas LFA test (Sensitivity, Specificity, PPV & NPV) in(predicting severe PE in the suspected preeclampsia population)