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

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.

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Key information

Conditions

Preeclampsia Blood Platelet Disorders Cardiovascular Diseases Cytopenia Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Hypertension, Pregnancy-Induced Impaired Liver Function Kidney Diseases Liver Diseases Lung Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Proteinuria Pulmonary Edema Renal Insufficiency Respiratory Tract Diseases Signs and Symptoms Thrombocytopenia Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Center of Research in Women's Health, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Suspected and Pre-E cases determined by institutional standards

Time frame: about 2 years

Sponsors and collaborators

Lead sponsor

Progenity, Inc.

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: May 23, 2016
Registry last updated: Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed