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

This study has been completed.
Sponsor:
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00809666
First received: December 15, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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). [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end points included gestation at birth, caesarean section and induction of labour rates. [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809666

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

No publications provided

Responsible Party: Professor Mark Brown, St George Hospital and UNSW
ClinicalTrials.gov Identifier: NCT00809666     History of Changes
Other Study ID Numbers: 00/41 Brown
Study First Received: December 15, 2008
Last Updated: December 15, 2008
Health Authority: Australia: Human Research Ethics Committee

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:
Eclampsia
Hypertension
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014