Clinical trial NCT02780414: Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Official title: Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Hypertension
Proteinuria
Thrombocytopenia
Renal Insufficiency
Impaired Liver Function
Pulmonary Edema
Keywords: Hypertension
Proteinuria
Thrombocytopenia
Renal Insufficiency
Impaired Liver Function
Pulmonary Edema
Lead sponsor: Progenity, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 1730
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Suspected and Pre-E cases determined by institutional standards
timeFrame: about 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Center of Research in Women's Health
state: Alabama
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Medical
state: Connecticut
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Physicians Women's Health
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington Univ School of Medicine - Dept of OB-GYN
state: Missouri
city: Mineola
country: United States
facility: Winthrop Clinical Trials Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Maternal Fetal Medicine
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch, Galveston
state: Texas
city: Houston
country: United States
facility: UT Health Medical School
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital, OB/GYN Dept.
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Department of Obstetrics & Gynecology
state: Wisconsin
Study officials:
affiliation: Progenity, Inc.
name: Peter Stiegler, PhD
role: STUDY_DIRECTOR
References:
citation: Costantine MM, Sibai B, Bombard AT, Sarno M, West H, Haas DM, Tita AT, Paidas MJ, Clark EAS, Boggess K, Grotegut C, Grobman W, Su EJ, Burd I, Saade G, Chavez MR, Paglia MJ, Merriam A, Torres C, Habli M, Macones G, Wen T, Bofill J, Palatnik A, Edwards RK, Haeri S, Oberoi P, Mazloom A, Cooper M, Lockton S, Hankins GD. Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia. Hypertension. 2022 Jul;79(7):1515-1524. doi: 10.1161/HYPERTENSIONAHA.122.19038. Epub 2022 May 12.