Maternal Serum Markers Predicting Preeclampsia at Early Gestations

Status Not yet recruiting

Clinical Trial Summary

The investigators aim to evaluate a blood test that can identify women at high-risk of PE at the 1st or early 2nd trimester.

Clinical Trial Description

PE incidence is 5-8% of all pregnancies in US and worldwide. Morbidity, mortality, and medical legal risks of missing PE often lead to over diagnosis. Currently there is no molecular blood laboratory developed test which can allow serial micro-samplings to assess the PE risk when asymptomatic at home setting along the duration of pregnancy. The hypothesis is that a blood test can predict PE with a sensitivity higher than 85% and a specificity higher than 80% at early gestation in a PE-Normal cohort. A single-site retrospective cohort of women who developed PE and women with normal pregnancy will be recruited. Blood samples have been collected from each subject once at the 1st trimester or early 2nd trimester. Delivery and neonatal data have been collected through chart reviews. Two groups (PE and Normal) are matched with age and clinical conditions. It is an observational study of the accuracy of a diagnostic test on PE prediction. There is only one group of participants. Participants will be tested using a blood test to determine positive or negative. Sensitivity and specificity (Primary outcomes) of the test will be measured at the end of study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05131282
Study type	Observational
Source	HBI Solutions Inc.
Contact	James Shilling, PhD
Phone	650-427-9198
Email	admin@mprobe.com
Status	Not yet recruiting
Phase
Start date	May 2022
Completion date	December 2023

View Details

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