Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-30 @ 10:17 PM
Study NCT ID:
NCT00809666
Status:
COMPLETED
Last Update Posted:
2008-12-17
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-15', 'studyFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).'}], 'secondaryOutcomes': [{'measure': 'Secondary end points included gestation at birth, caesarean section and induction of labour rates.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'hypertension', 'mercury sphygmomanometry', 'blood pressure', 'automated blood pressure', 'pre eclampsia', 'Hypertension in pregnancy'], 'conditions': ['Hypertension', 'Pregnancy', 'Pre Eclampsia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'High blood pressure research Council of Australia. Position Statement on the replacement of mercury sphygmomanometers. September 2006. www.hbprca.com.au'}, {'pmid': '32748394', 'type': 'DERIVED', 'citation': 'Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the PRAM study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with a diagnosis of hypertension in pregnancy\n\nExclusion Criteria:\n\n* non-pregnant and normotensive pregnancy women'}, 'identificationModule': {'nctId': 'NCT00809666', 'acronym': 'PRAM', 'briefTitle': 'Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device', 'organization': {'class': 'OTHER', 'fullName': 'St George Hospital, Australia'}, 'officialTitle': 'A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy', 'orgStudyIdInfo': {'id': '00/41 Brown'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Mercury', 'description': 'All subsequent blood pressure recording done using mercury sphygmomanometry', 'interventionNames': ['Device: Automated blood pressure recording device Omron HEM 705CP']}], 'interventions': [{'name': 'Automated blood pressure recording device Omron HEM 705CP', 'type': 'DEVICE', 'description': 'All subsequent blood pressure recordings done using the automated device', 'armGroupLabels': ['Mercury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2217', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St George Hospital, Australia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Mark Brown', 'oldOrganization': 'St George Hospital and UNSW'}}}}