NCT00809666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2000

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
Last Updated

December 17, 2008

Status Verified

December 1, 2008

Enrollment Period

6.3 years

First QC Date

December 15, 2008

Last Update Submit

December 15, 2008

Conditions

HypertensionPregnancyPre Eclampsia

Keywords

pregnancyhypertensionmercury sphygmomanometryblood pressureautomated blood pressurepre eclampsiaHypertension in pregnancy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

Mercury

NO INTERVENTION

All subsequent blood pressure recording done using mercury sphygmomanometry

Device: Automated blood pressure recording device Omron HEM 705CP

Interventions

Automated blood pressure recording device Omron HEM 705CPDEVICE

All subsequent blood pressure recordings done using the automated device

Mercury

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women with a diagnosis of hypertension in pregnancy

You may not qualify if:

  • non-pregnant and normotensive pregnancy women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George Hospital

Sydney, New South Wales, 2217, Australia

Location

Related Publications (2)

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

    BACKGROUND

  • Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.

    PMID: 32748394DERIVED

MeSH Terms

Conditions

HypertensionPre-EclampsiaHypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 17, 2008

Study Start

May 1, 2000

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

December 17, 2008

Record last verified: 2008-12

Locations

AU(1)