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Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device (PRAM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809666
First Posted: December 17, 2008
Last Update Posted: December 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St George Hospital, Australia
  Purpose
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.

Condition Intervention
Hypertension Pregnancy Pre Eclampsia Device: Automated blood pressure recording device Omron HEM 705CP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy

Resource links provided by NLM:


Further study details as provided by St George Hospital, Australia:

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.

Enrollment: 220
Study Start Date: May 2000
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Mercury
All subsequent blood pressure recording done using mercury sphygmomanometry
Device: Automated blood pressure recording device Omron HEM 705CP
All subsequent blood pressure recordings done using the automated device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with a diagnosis of hypertension in pregnancy

Exclusion Criteria:

  • non-pregnant and normotensive pregnancy women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809666


Locations
Australia, New South Wales
St George Hospital
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
  More Information

Publications:
High blood pressure research Council of Australia. Position Statement on the replacement of mercury sphygmomanometers. September 2006. www.hbprca.com.au

Responsible Party: Professor Mark Brown, St George Hospital and UNSW
ClinicalTrials.gov Identifier: NCT00809666     History of Changes
Other Study ID Numbers: 00/41 Brown
First Submitted: December 15, 2008
First Posted: December 17, 2008
Last Update Posted: December 17, 2008
Last Verified: December 2008

Keywords provided by St George Hospital, Australia:
pregnancy
hypertension
mercury sphygmomanometry
blood pressure
automated blood pressure
pre eclampsia
Hypertension in pregnancy

Additional relevant MeSH terms:
Hypertension
Eclampsia
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications