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

This study is currently recruiting participants.
Verified May 2016 by Progenity, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780414
First Posted: May 23, 2016
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Progenity, Inc.
  Purpose

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
Preeclampsia Hypertension Proteinuria Thrombocytopenia Renal Insufficiency Impaired Liver Function Pulmonary Edema

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers

Resource links provided by NLM:


Further study details as provided by Progenity, Inc.:

Primary Outcome Measures:
  • Suspected and Pre-E cases determined by institutional standards [ Time Frame: about 2 years ]

Biospecimen Retention:   Samples Without DNA
This research study will collect 20 mL of whole blood and a 5 mL urine sample at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.

Estimated Enrollment: 1791
Study Start Date: January 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Cohort
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women 18 to 45 years of age and 28 0/7 to 36 6/7 weeks gestational age with a singleton fetus presenting to clinic/triage/Labor & Delivery for evaluation of, but not limited to, one or more of the following:

  • new onset elevated blood pressure
  • pre-existing hypertension
  • new onset proteinuria or worsening of pre-existing proteinuria
  • other organ system findings including thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, and cerebral or visual symptoms
Criteria

Eligibility criteria for the STUDY COHORT (CASES and NEGATIVE PRE-E

CONTROLS):

Inclusion Criteria:

  • Subject is willing to provide informed consent and comply with study procedures
  • 18 to 45 years of age
  • Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American Congress of Obstetricians and Gynecologists (ACOG) Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
  • Patient presenting with clinical suspicion of Pre-E based on either: New onset elevated blood pressure in otherwise normotensive patient, worsening hypertension in a patient with pre-existing hypertension, new onset proteinuria or worsening of pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out Pre-E.

Exclusion Criteria:

  • Pregnancy is non-viable or absence of fetal cardiac activity
  • Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with severe features including: persistent severe hypertension (systolic ≥160 or diastolic ≥110; thrombocytopenia <100,000; liver enzymes 2x above upper normal limit or >70 with severe persistent right upper quadrant (RUQ) or epigastric pain, new development of renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual disturbances.
  • Major fetal anomaly or chromosomal aneuploidy
  • Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis

Eligibility criteria for the POSITIVE CONTROL group:

Inclusion Criteria:

  • Subject is willing to provide informed consent and comply with study procedures
  • 18 to 45 years of age
  • Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
  • Patient diagnosed with Pre-E using 2013 ACOG guidelines

Exclusion Criteria:

  • Pregnancy is non-viable or absence of cardiac activity
  • Major fetal anomaly or chromosomal aneuploidy
  • Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Zulema Sanchez, BA 760-494-1742 zulema.sanchez@progenity.com
Contact: Paul A Bien, MS 760-494-1743 paul.bien@progenity.com

Locations
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    atita@uab.edu   
Contact: Stacy Harris    205-996-6262    stacylharris@uabmc.edu   
United States, Indiana
Indiana University Health Physicians Women's Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Haas, MD, MS    317-880-3960    dahaas@iu.edu   
Contact: Shelly Dowden, BS, CCRP    317-880-3954    sburn@iupui.edu   
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    kboggess@med.unc.edu   
Contact: Karen Dorman, RN, MS    984-974-9012    kdorman@med.unc.edu   
United States, Texas
University of Texas Medical Branch, Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Maged Costantine, MD    409-747-6647    mmcostan@utmb.edu   
Contact: Holly West, DHEd, PA-C    409-747-8234    hawest@utmb.edu   
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.clark@hsc.utah.edu   
Contact: Alex Burringo    801-587-0975    alex.burringo@hsc.utah.edu   
Sponsors and Collaborators
Progenity, Inc.
Investigators
Study Director: Paul Bien, MS Director of Clinical Affairs
  More Information

Responsible Party: Progenity, Inc.
ClinicalTrials.gov Identifier: NCT02780414     History of Changes
Other Study ID Numbers: PRO-104-PREECLAMPSIA
First Submitted: May 12, 2016
First Posted: May 23, 2016
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Progenity, Inc.:
Hypertension
Proteinuria
Thrombocytopenia
Renal Insufficiency
Impaired Liver Function
Pulmonary Edema

Additional relevant MeSH terms:
Hypertension
Thrombocytopenia
Renal Insufficiency
Pre-Eclampsia
Proteinuria
Pulmonary Edema
Liver Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Urination Disorders
Urological Manifestations
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases