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Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification

NCT03815110 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1050

Last updated 2022-11-28

No results posted yet for this study

Summary

The purpose of this study is to

1. Identify a cut-off for the ratio of the serum proteins soluble FMS-like Tyrosine Kinase 1 (sFLT-1) and placental growth factor (PlGF) that identifies women will who develop preeclampsia with severe features within 2 weeks of testing (clinically positive) from those who do not develop preeclampsia with severe features within 2 weeks of testing (clinically negative) among preterm pregnant women with hypertensive disorders of pregnancy.

And
2. To validate the cut-off the ratio of sFLT-1 and PlGF and to validate the performance of the automated assays used to find the cut-off. Test performance includes positive predictive value, negative predictive value, sensitivity, and specificity.

Subjects will provide blood, urine, and saliva samples at the time of enrollment. Samples will be frozen for batch assessment of sFLT-1 and PlGF levels by automated assays. Clinicians, subjects, and researchers will be blinded to protein level assessment, therefore assay results will not affect clinical management.

Conditions

  • Preeclampsia and Eclampsia
  • Preeclampsia Severe
  • Gestational Hypertension
  • Chronic Hypertension in Obstetric Context
  • Superimposed Pre-Eclampsia
  • Preeclampsia Mild

Sponsors & Collaborators

  • ThermoFisher Scientific Brahms Biomarkers France

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Ananth Karumanchi, MD · Cedars-Sinai Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2021-11-19
Completion
2022-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815110 on ClinicalTrials.gov