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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00809666
Registration number
NCT00809666
Ethics application status
Date submitted
15/12/2008
Date registered
17/12/2008
Date last updated
17/12/2008
Titles & IDs
Public title
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device
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Scientific title
A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy
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Secondary ID [1]
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00/41 Brown
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Universal Trial Number (UTN)
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Trial acronym
PRAM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Pregnancy
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Pre Eclampsia
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Condition category
Condition code
Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Automated blood pressure recording device Omron HEM 705CP
No Intervention: Mercury - All subsequent blood pressure recording done using mercury sphygmomanometry
Treatment: Devices: Automated blood pressure recording device Omron HEM 705CP
All subsequent blood pressure recordings done using the automated device
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Secondary end points included gestation at birth, caesarean section and induction of labour rates.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- women with a diagnosis of hypertension in pregnancy
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Minimum age
16
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- non-pregnant and normotensive pregnancy women
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
220
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St George Hospital - Sydney
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Recruitment postcode(s) [1]
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2217 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
St George Hospital, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00809666
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Trial related presentations / publications
High blood pressure research Council of Australia. Position Statement on the replacement of mercury sphygmomanometers. September 2006. www.hbprca.com.au
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00809666
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