Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
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|ClinicalTrials.gov Identifier: NCT02780414|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2016
Last Update Posted : August 21, 2019
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.
|Condition or disease|
|Preeclampsia Hypertension Proteinuria Thrombocytopenia Renal Insufficiency Impaired Liver Function Pulmonary Edema|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1791 participants|
|Official Title:||Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||January 2020|
A group of at least 1,541 pregnant women with NO Pre-E diagnosis
Positive Pre-E Control
A group of at least 250 pregnant women diagnosed with Pre-E
- Suspected and Pre-E cases determined by institutional standards [ Time Frame: about 2 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780414
|Study Director:||Peter Stiegler, PhD||Progenity, Inc.|