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

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ClinicalTrials.gov Identifier: NCT02780414
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Progenity, Inc.

Brief 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.


Condition or disease
Preeclampsia Hypertension Proteinuria Thrombocytopenia Renal Insufficiency Impaired Liver Function Pulmonary Edema

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
Estimated Enrollment : 1791 participants
Observational Model: Family-Based
Time Perspective: Prospective
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 : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


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

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: Alanna Menez 8582605216 alanna.menez@progenity.com
Contact: Peter Stiegler, PhD 760-494-1743 peter.stiegler@progenity.com

  Show 20 Study Locations
Sponsors and Collaborators
Progenity, Inc.
Investigators
Study Director: Peter Stiegler, PhD Progenity, Inc.

Responsible Party: Progenity, Inc.
ClinicalTrials.gov Identifier: NCT02780414     History of Changes
Other Study ID Numbers: PRO-104-PREECLAMPSIA
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
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
Pre-Eclampsia
Renal Insufficiency
Proteinuria
Pulmonary Edema
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases