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

December 15, 2008 updated by: St George Hospital, Australia

A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2217
        • St George Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with a diagnosis of hypertension in pregnancy

Exclusion Criteria:

  • non-pregnant and normotensive pregnancy women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).

Secondary Outcome Measures

Outcome Measure
Secondary end points included gestation at birth, caesarean section and induction of labour rates.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George Hospital, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2008

Last Update Submitted That Met QC Criteria

December 15, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00/41 Brown

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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