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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy
Secondary ID [1] 0 0
00/41 Brown
Universal Trial Number (UTN)
Trial acronym
PRAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Pregnancy 0 0
Pre Eclampsia 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Secondary end points included gestation at birth, caesarean section and induction of labour rates.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* women with a diagnosis of hypertension in pregnancy
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* non-pregnant and normotensive pregnancy women

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00809666
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
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00809666