Trial Review

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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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00809666