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

March 10, 2022 updated by: Progenity, Inc.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1730

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Center of Research in Women's Health
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Medical
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Physicians Women's Health
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63111
        • Washington Univ School of Medicine - Dept of OB-GYN
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop Clinical Trials Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7516
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Regional Obstetrical Consultants, PC
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Maternal Fetal Medicine
      • Galveston, Texas, United States, 77555
        • University of Texas medical branch, Galveston
      • Houston, Texas, United States, 77030
        • UT Health Medical School
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital, OB/GYN Dept.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin - Department of Obstetrics & Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Suspected and Pre-E cases determined by institutional standards
Time Frame: about 2 years
about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progenity, Inc.

Investigators

  • Study Director: Peter Stiegler, PhD, Progenity, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 29, 2020

Study Completion (Actual)

October 23, 2020

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-104-PREECLAMPSIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe