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Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers

NCT02780414 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1730

Last updated 2022-03-11

No results posted yet for this study

Summary

Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method has emerged that more accurately identifies women at risk for preeclampsia, warranting improvements in diagnosing Pre-E.

This sample collection study will obtain serum and urine samples from pregnant women who present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of Pre-E.

Conditions

Sponsors & Collaborators

  • Progenity, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Stiegler, PhD · Progenity, Inc.

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-09-29
Completion
2020-10-23

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02780414 on ClinicalTrials.gov