PRAM: Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device

• Sponsor: St George Hospital, Australia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00809666
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arm: 1
• Duration (Months): 76
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Pregnancy; Pre Eclampsia	Device: Automated blood pressure recording device Omron HEM 705CP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• 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
• Study Start Date: May 1, 2000
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: Sep 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Secondary end points included gestation at birth, caesarean section and induction of labour rates. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women with a diagnosis of hypertension in pregnancy

Exclusion Criteria:

• non-pregnant and normotensive pregnancy women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St George Hospital	Sydney	New South Wales	Australia	2217

Sponsors and Collaborators

• St George Hospital, Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• ClinicalTrials.gov Identifier: NCT00809666
• Other Study ID Numbers: 00/41 Brown
• First Posted: Dec 17, 2008
• Last Update Posted: Dec 17, 2008
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: pregnancy; hypertension; mercury sphygmomanometry; blood pressure; automated blood pressure; pre eclampsia; Hypertension in pregnancy
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Hypertension

Study Results

No Results Posted as of Dec 17, 2008