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

Sponsor

Progenity, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02780414

Collaborator

(none)

1,730

Enrollment

Locations

57.7

Actual Duration (Months)

86.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

1730 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Sep 29, 2020

Actual Study Completion Date :

Oct 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Suspected and Pre-E cases determined by institutional standards [about 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Center of Research in Women's Health	Birmingham	Alabama	United States	35294
2	University of Colorado	Aurora	Colorado	United States	80045
3	Yale Medical	New Haven	Connecticut	United States	06520
4	Northwestern	Chicago	Illinois	United States	60611
5	Indiana University Health Physicians Women's Health	Indianapolis	Indiana	United States	46202
6	Johns Hopkins Medicine	Baltimore	Maryland	United States	21287
7	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
8	Washington Univ School of Medicine - Dept of OB-GYN	Saint Louis	Missouri	United States	63111
9	Winthrop Clinical Trials Center	Mineola	New York	United States	11501
10	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7516
11	Duke University	Durham	North Carolina	United States	27705
12	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
13	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
14	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
15	Regional Obstetrical Consultants, PC	Chattanooga	Tennessee	United States	37403
16	Austin Maternal Fetal Medicine	Austin	Texas	United States	78758
17	University of Texas Medical Branch, Galveston	Galveston	Texas	United States	77555
18	UT Health Medical School	Houston	Texas	United States	77030
19	University of Utah Hospital, OB/GYN Dept.	Salt Lake City	Utah	United States	84132
20	Medical College of Wisconsin - Department of Obstetrics & Gynecology	Milwaukee	Wisconsin	United States	53226