Back to resultsMeasuring Blood Pressure in Pregnancy Using Mercury and Automated Device (PRAM)
Primary Purpose
Hypertension, Pregnancy, Pre Eclampsia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Automated blood pressure recording device Omron HEM 705CP
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertension focused on measuring pregnancy, hypertension, mercury sphygmomanometry, blood pressure, automated blood pressure, pre eclampsia, Hypertension in pregnancy
Eligibility Criteria
Inclusion Criteria:
- women with a diagnosis of hypertension in pregnancy
Exclusion Criteria:
- non-pregnant and normotensive pregnancy women
Sites / Locations
- St George Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Mercury
Arm Description
All subsequent blood pressure recording done using mercury sphygmomanometry
Outcomes
Primary Outcome Measures
The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
Secondary Outcome Measures
Secondary end points included gestation at birth, caesarean section and induction of labour rates.
Full Information
NCT ID
NCT00809666
First Posted
December 15, 2008
Last Updated
December 15, 2008
Sponsor
St George Hospital, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00809666
Brief Title
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device
Acronym
PRAM
Official Title
A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St George Hospital, Australia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy, Pre Eclampsia
Keywords
pregnancy, hypertension, mercury sphygmomanometry, blood pressure, automated blood pressure, pre eclampsia, Hypertension in pregnancy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mercury
Arm Type
No Intervention
Arm Description
All subsequent blood pressure recording done using mercury sphygmomanometry
Intervention Type
Device
Intervention Name(s)
Automated blood pressure recording device Omron HEM 705CP
Intervention Description
All subsequent blood pressure recordings done using the automated device
Primary Outcome Measure Information:
Title
The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
Secondary Outcome Measure Information:
Title
Secondary end points included gestation at birth, caesarean section and induction of labour rates.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with a diagnosis of hypertension in pregnancy
Exclusion Criteria:
non-pregnant and normotensive pregnancy women
Facility Information:
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
12. IPD Sharing Statement
Citations:
Citation
High blood pressure research Council of Australia. Position Statement on the replacement of mercury sphygmomanometers. September 2006. www.hbprca.com.au
Results Reference
background
PubMed Identifier
32748394
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.
Results Reference
derived
Learn more about this trial
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device
We'll reach out to this number within 24 hrs