Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT03767803
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 344}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of preeclampsia is determined by standard of care.', 'timeFrame': '3 months', 'description': 'Observational, non-interventional sample procurement study in which participants are treated per standard of care'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Proteinuria', 'Thrombocytopenia', 'Renal Insufficiency', 'Impaired Liver Function', 'Pulmonary Edema', 'Cerebral Symptoms', 'Visual Symptoms'], 'conditions': ['Pre-Eclampsia', 'Hypertension', 'Proteinuria in Pregnancy', 'Thrombocytopenia', 'Renal Insufficiency', 'Impaired Liver Function', 'Pulmonary Edema', 'Headache', 'Visual Impairment']}, 'descriptionModule': {'briefSummary': 'Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.', 'detailedDescription': "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.\n\nStudy 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 18 to 45 years of age\n* Subject is willing to provide informed consent\n* 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\n* 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)\n* Patient presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:\n\n * New onset increased blood pressure in otherwise normotensive patient\n * Worsening hypertension in a patient with pre-existing hypertension\n * New onset proteinuria or worsening of pre-existing proteinuria\n * Any other clinical finding typically associated with suspicion of Pre-E and requiring workup to rule-out Pre-E\n\nExclusion Criteria:\n\n* Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity\n* Major fetal anomaly or chromosomal aneuploidy\n* Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis"}, 'identificationModule': {'nctId': 'NCT03767803', 'briefTitle': 'Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Progenity, Inc.'}, 'officialTitle': 'Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers', 'orgStudyIdInfo': {'id': 'PRO-129-PREECLAMPSIA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive Preeclampsia group', 'description': 'A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery', 'interventionNames': ['Other: Non-interventional study']}, {'label': 'Study Cohort', 'description': '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.', 'interventionNames': ['Other: Non-interventional study']}], 'interventions': [{'name': 'Non-interventional study', 'type': 'OTHER', 'description': 'This is an observational, non-interventional study.', 'armGroupLabels': ['Positive Preeclampsia group', 'Study Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Medical Research, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33433', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Women's Health Partners, LLC", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Discovery Clinical Research', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Leavitt Clinical Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Obstetrics and Gynecology Associates AMB', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Valley OB-GYN Clinic, PC', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers-RWJMS', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Peter's University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Voorhees Hospital', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '11220', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New Life Medical Esthetics and Wellness, PLLC', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28621', 'city': 'Elkin', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Total Woman Care', 'geoPoint': {'lat': 36.2443, 'lon': -80.8484}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'David B. Schwartz, MD, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45014', 'city': 'Fairfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Obstetrics & Gynecology Associates, Inc.', 'geoPoint': {'lat': 39.34589, 'lon': -84.5605}}, {'zip': '45005', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hilltop Obstetrics & Gynecology', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dr. Ahuja and Associates OB-GYN', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Jackson Clinic, PA', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Aa Ob-Gyn, Pllc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'OB-GYN North', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78412', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': "Corpus Christi Women's Clinic", 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Peter Stiegler, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Progenity, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Progenity, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}