Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01261351
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2010-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Coagulation Activation Markers and Pre Eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Maternal blood and urine\n* cord blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2010-10-26', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endogenous thrombin potential', 'timeFrame': 'at preeclampsia diagnosis', 'description': 'comparison of Endogenous thrombin potential between patients with Preclampsia (PE) (at the moment of the diagnosis of PE) compared to control (at the same gestational age)'}], 'secondaryOutcomes': [{'measure': 'genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1', 'timeFrame': 'at pre eclampsia diagnosis'}, {'measure': 'In preeclampsia group : correlation between biological markers and severity of the disease', 'timeFrame': 'at the diagnosis of preeclampsia', 'description': 'correlation of endogenous thrombin potential and rotem results with : presence or absence of severe preeclampsia presence or absence of HELLP Syndrome presence or absence of IUGR presence or absence of eclampsia'}, {'measure': 'evolution of endogenous thrombin potential in women with preeclampsia', 'timeFrame': 'between the diagnosis of preeclampsia and day 2 of the post partum period', 'description': 'Study of the evolution of endogenous thrombin potential during the time period of diagnosis of preeclampsia to day 2 of the post partum.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pre eclampsia', 'Endogenous thrombin potential'], 'conditions': ['Pre Eclampsia']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.', 'detailedDescription': "100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section).\n\nBlood and urine samples will be collected at PE diagnosis, delivery and post partum.\n\nTwo axes will be considered:\n\n1. Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers).\n2. The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women from two University hospitals in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old\n* diagnosis of pre eclampsia\n\nExclusion Criteria:\n\n* multiple pregnancy\n* less than 18 year old'}, 'identificationModule': {'nctId': 'NCT01261351', 'acronym': 'PRESTIGE', 'briefTitle': 'Study of Coagulation Activation Markers and Pre Eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications', 'orgStudyIdInfo': {'id': '2008_16/0921'}, 'secondaryIdInfos': [{'id': 'PHRC 2009/1910', 'type': 'OTHER_GRANT', 'domain': 'hospital clinical research program, French health ministry'}, {'id': '2009-A00526-51', 'type': 'OTHER', 'domain': 'ID-RCB number, AFSSAPS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Véronique Houfflin Debarge, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universituy Hospital Of Lille, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}