Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT02136667
Status:
UNKNOWN
Last Update Posted:
2015-01-06
First Post:
2014-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preeclampsia and Circulating Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'Blood serum Blood plasma Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-05', 'studyFirstSubmitDate': '2014-05-01', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating biomarkers of cardiovascular disease 10 years postpartum.', 'timeFrame': '10 years postpartum'}], 'secondaryOutcomes': [{'measure': 'Markers of arteriosclerosis and atherosclerosis', 'timeFrame': '10 years postpartum'}, {'measure': 'Circulating biomarkers of cardiovascular disease at baseline pregnancy.', 'timeFrame': 'During pregnancy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preeclampsia', 'Cardiovascular disease (CVD) risk'], 'conditions': ['Postpartum CVD Risk in Women With Previous Preeclampsia.']}, 'descriptionModule': {'briefSummary': 'In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year follow-up study comparing 32 exposed (women with a history of pregnancy complicated by preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).\n\nParticipants will be recruited from a well-characterised cohort, previously assembled during their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in 2001-2004.\n\nBlood and urine samples, collected during their pregnancies, are stored in a biobank, thus rendering the possibility of longitudinal assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from a well-characterised cohort, previously assembled at the Department of Obstetrics at Randers Regional Hospital in 2001-2005.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in previous study 2001-2005.\n\nExclusion Criteria:\n\n* Current pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02136667', 'briefTitle': 'Preeclampsia and Circulating Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'orgStudyIdInfo': {'id': '98372017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed', 'description': 'Women with a history of preeclampsia 10 years ago'}, {'label': 'Unexposed', 'description': 'Women with a history of uncomplicated pregnancy 10 years ago'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8930', 'city': 'Randers', 'state': 'Randers NØ', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Martin Christensen, MD', 'role': 'CONTACT', 'email': 'marticis@rm.dk', 'phone': '004578422354'}, {'name': 'Martin Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Randers Regional Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'overallOfficials': [{'name': 'Ulla B Knudsen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynaecology, Aarhus University Hospital'}, {'name': 'Martin Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Unit, Randers Regional Hospital'}, {'name': 'Camilla S Kronborg, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oncology, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Randers Regional Hospital', 'class': 'OTHER'}, {'name': 'Karen Elise Jensen Foundation', 'class': 'OTHER'}, {'name': 'Central Denmark Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}