ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03767803
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Progenity, Inc.

Brief Summary:
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.

Condition or disease Intervention/treatment
Pre-Eclampsia Hypertension Proteinuria in Pregnancy Thrombocytopenia Renal Insufficiency Impaired Liver Function Pulmonary Edema Headache Visual Impairment Other: Non-interventional study

Detailed Description:

This multicenter non-interventional observational sample acquisition study is designed to acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as outpatient centers, clinic sites, and medical offices.

Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.


Study Type : Observational
Estimated Enrollment : 344 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Positive Preeclampsia group
A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery
Other: Non-interventional study
This is an observational, non-interventional study.

Study Cohort
A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery.
Other: Non-interventional study
This is an observational, non-interventional study.




Primary Outcome Measures :
  1. Diagnosis of preeclampsia is determined by standard of care. [ Time Frame: 3 months ]
    Observational, non-interventional sample procurement study in which participants are treated per standard of care


Biospecimen Retention:   Samples With DNA
This study will collect 20 mL whole blood samples from subjects at one or more study visits. The whole blood will be processed to plasma and stored for testing.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
Criteria

Inclusion Criteria:

  • Subject is 18 to 45 years of age
  • Subject is willing to provide informed consent
  • Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician able to provide 20 mL of whole blood and will comply with all study procedures
  • Subject has a 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 presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:

    • New onset increased blood pressure in otherwise normotensive patient
    • Worsening hypertension in a patient with pre-existing hypertension
    • New onset proteinuria or worsening of pre-existing proteinuria
    • Any other clinical finding typically associated with suspicion of Pre-E and requiring workup to rule-out Pre-E

Exclusion Criteria:

  • Pregnancy is non-viable, as evidenced by absence of fetal 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): NCT03767803


Contacts
Contact: Alanna Menez 858-260-5216 alanna.menez@progenity.com
Contact: Peter Stiegler, PhD 760-494-1743 peter.stiegler@progenity.com

  Show 24 Study Locations
Sponsors and Collaborators
Progenity, Inc.
Investigators
Study Director: Peter Stiegler, PhD Progenity, Inc.

Responsible Party: Progenity, Inc.
ClinicalTrials.gov Identifier: NCT03767803     History of Changes
Other Study ID Numbers: PRO-129-PREECLAMPSIA
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Progenity, Inc.:
Hypertension
Proteinuria
Thrombocytopenia
Renal Insufficiency
Impaired Liver Function
Pulmonary Edema
Cerebral Symptoms
Visual Symptoms

Additional relevant MeSH terms:
Hypertension
Headache
Thrombocytopenia
Pre-Eclampsia
Renal Insufficiency
Proteinuria
Eclampsia
Pulmonary Edema
Vision Disorders
Vision, Low
Vascular Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Blood Platelet Disorders
Hematologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Lung Diseases
Respiratory Tract Diseases
Sensation Disorders
Eye Diseases