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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780414
• Other study ID #: PRO-104-PREECLAMPSIA
• Status: Completed
• Start date: January 2016
• Est. completion date: October 23, 2020

Study information

• Verified date: March 2022
• Source: Progenity, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1730
• Est. completion date: October 23, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Impaired Liver Function
• Pre-Eclampsia
• Preeclampsia
• Proteinuria
• Pulmonary Edema
• Renal Insufficiency
• Thrombocytopenia

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Austin Maternal Fetal Medicine	Austin	Texas
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	Center of Research in Women's Health	Birmingham	Alabama
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Regional Obstetrical Consultants, PC	Chattanooga	Tennessee
United States	Northwestern	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Duke University	Durham	North Carolina
United States	University of Texas Medical Branch, Galveston	Galveston	Texas
United States	UT Health Medical School	Houston	Texas
United States	Indiana University Health Physicians Women's Health	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Medical College of Wisconsin - Department of Obstetrics & Gynecology	Milwaukee	Wisconsin
United States	Winthrop Clinical Trials Center	Mineola	New York
United States	Yale Medical	New Haven	Connecticut
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Washington Univ School of Medicine - Dept of OB-GYN	Saint Louis	Missouri
United States	University of Utah Hospital, OB/GYN Dept.	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Progenity, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suspected and Pre-E cases determined by institutional standards		about 2 years