Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-05-22 @ 11:30 AM
Study NCT ID:
NCT01068002
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2010-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2010-02-11', 'studyFirstSubmitQcDate': '2010-02-11', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension Pregnancy'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'Cardiovascular \\& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.', 'detailedDescription': 'Cardiovascular \\& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women. Also,comparing echocardiographic parameters in hypertensive pregnant women being treated with either alfa methyl dopa or labetolol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hypertension during pregnancy: Chronic or pregnancy induced\n\nExclusion Criteria:\n\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT01068002', 'acronym': 'CREATION-P', 'briefTitle': 'Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Hypertension During Pregnancy: Cardiovascular & Echocardiographic Assessment: CREATION - P (01)', 'orgStudyIdInfo': {'id': '071-09-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control, normotensive, pregnancy', 'description': 'Control, normotensive, pregnancy'}, {'label': 'hypertension, pregnancy, no treatment', 'description': 'hypertension, pregnancy, no treatment'}, {'label': 'hypertension, pregnancy, drug treatment', 'description': 'hypertension, pregnancy, drug treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': "Ha'Emek Medical Center", 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Limor I Bushari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Heart Institute, Ha'Emek Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Limor Ilan- Bushari', 'oldOrganization': "Ha'Emek Medical Center"}}}}