Trials / Completed

CompletedNCT02780414

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,730 (actual)

Sponsor: Progenity, Inc. · Industry
Sex: Female
Age: 18 Years – 45 Years
Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects will provide written informed consent after which demographic and baseline clinical data will be recorded. Collection of whole blood and urine samples will be performed at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities. Interim study visits will continue every 14 days \[+/- 3 days\] until the subject either: 1) reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up. In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive control cases.

Conditions

Timeline

Start date: 2016-01-01
Primary completion: 2020-09-29
Completion: 2020-10-23
First posted: 2016-05-23
Last updated: 2022-03-11

Locations

20 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02780414. Inclusion in this directory is not an endorsement.