Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device

Not Applicable

Completed

• Conditions: Hypertension; Pregnancy; Pre Eclampsia
• Interventions: Device: Automated blood pressure recording device Omron HEM 705CP

• Registration Number: NCT00809666
• Lead Sponsor: St George Hospital, Australia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2008-12
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Last Update Submitted: 2008-12-15
• Study First Posted: 2008-12-17
• Last Update Posted: 2008-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• women with a diagnosis of hypertension in pregnancy

Exclusion Criteria

• non-pregnant and normotensive pregnancy women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mercury	Automated blood pressure recording device Omron HEM 705CP	All subsequent blood pressure recording done using mercury sphygmomanometry

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary end points included gestation at birth, caesarean section and induction of labour rates.

Trial Locations

Locations (1)

St George Hospital; 🇦🇺 Sydney, New South Wales, Australia