Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device

Hypertension Clinical Trial

— PRAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809666
• Other study ID #: 00/41 Brown
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: December 15, 2008
• Start date: May 2000
• Est. completion date: September 2006

Study information

• Verified date: December 2008
• Source: St George Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• women with a diagnosis of hypertension in pregnancy

Exclusion Criteria:

• non-pregnant and normotensive pregnancy women

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Pre Eclampsia
• Pre-Eclampsia
• Pregnancy

Intervention

Device:
• Automated blood pressure recording device Omron HEM 705CP
All subsequent blood pressure recordings done using the automated device

Locations

Country	Name	City	State
Australia	St George Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
St George Hospital, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).			No
Secondary	Secondary end points included gestation at birth, caesarean section and induction of labour rates.			No