Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
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|ClinicalTrials.gov Identifier: NCT02780414|
Recruitment Status : Unknown
Verified May 2016 by Progenity, Inc..
Recruitment status was: Recruiting
First Posted : May 23, 2016
Last Update Posted : May 23, 2016
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|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
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
|Contact: Zulema Sanchez, BAfirstname.lastname@example.org|
|Contact: Paul A Bien, MSemail@example.com|
|United States, Alabama|
|Center of Research in Women's Health||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Alan Tita, MD, MPH, PhD 205-934-9616 firstname.lastname@example.org|
|Contact: Stacy Harris 205-996-6262 email@example.com|
|United States, Indiana|
|Indiana University Health Physicians Women's Health||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: David Haas, MD, MS 317-880-3960 firstname.lastname@example.org|
|Contact: Shelly Dowden, BS, CCRP 317-880-3954 email@example.com|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7516|
|Contact: Kim Boggess, MD 919-966-1601 firstname.lastname@example.org|
|Contact: Karen Dorman, RN, MS 984-974-9012 email@example.com|
|United States, Texas|
|University of Texas Medical Branch, Galveston||Recruiting|
|Galveston, Texas, United States, 77555|
|Contact: Maged Costantine, MD 409-747-6647 firstname.lastname@example.org|
|Contact: Holly West, DHEd, PA-C 409-747-8234 email@example.com|
|United States, Utah|
|University of Utah Hospital, OB/GYN Dept.||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Erin Clark, MD 801-680-1395 Erin.firstname.lastname@example.org|
|Contact: Alex Burringo 801-587-0975 email@example.com|
|Study Director:||Paul Bien, MS||Director of Clinical Affairs|