HypertensionPRAMNCT00809666
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device
A study testing Automated blood pressure recording device Omron HEM 705CP in people with Hypertension and Pregnancy, run by St George Hospital, Australia at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pregnancy, Pre Eclampsia
- What is being tested?
- Automated blood pressure recording device Omron HEM 705CP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteAustralia
- Study dates
- May 2000to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- women with a diagnosis of hypertension in pregnancy
Who cannot join
- non-pregnant and normotensive pregnancy women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy
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.
- Conditions
- Hypertension, Pregnancy, Pre Eclampsia
- Being tested
- Automated blood pressure recording device Omron HEM 705CP
- Keywords
- pregnancy, hypertension, mercury sphygmomanometry, blood pressure, automated blood pressure, pre eclampsia, Hypertension in pregnancy
- Medical subject headings
- Hypertension, Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated blood pressure recording device Omron HEM 705CPDevice
All subsequent blood pressure recordings done using the automated device
| Study group | Role | What they receive |
|---|---|---|
| Mercury | No intervention | All subsequent blood pressure recording done using mercury sphygmomanometry Receives: Device: Automated blood pressure recording device Omron HEM 705CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startMay 2000
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809666
- Sponsor's protocol ID
- 00/41 Brown
- Acronym
- PRAM
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
High blood pressure research Council of Australia. Position Statement on the replacement of mercury sphygmomanometers. September 2006. www.hbprca.com.au
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.
PubMed 32748394
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy
- ClinicalTrials.gov ID
- NCT00809666
- Acronym / sponsor ID
- PRAM / 00/41 Brown
- Conditions
- Hypertension, Pregnancy, Pre Eclampsia
- Keywords
- pregnancy, hypertension, mercury sphygmomanometry, blood pressure, automated blood pressure, pre eclampsia, Hypertension in pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mercury | No intervention | Device: Automated blood pressure recording device Omron HEM 705CPAll subsequent blood pressure recording done using mercury sphygmomanometry |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- women with a diagnosis of hypertension in pregnancy
Key exclusion criteria (1 listed)
- non-pregnant and normotensive pregnancy women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated blood pressure recording device Omron HEM 705CPAll subsequent blood pressure recordings done using the automated device | Device | Mercury |
Primary outcome
The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
1 secondary outcome
Secondary end points included gestation at birth, caesarean section and induction of labour rates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2008.
- BackgroundHigh blood pressure research Council of Australia. Position Statement on the replacement of mercury sphygmomanometers. September 2006. www.hbprca.com.au
- Derived from this study: PubMed 32748394Ashworth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated blood pressure recording device Omron HEM 705CP in people with Hypertension and Pregnancy, run by St George Hospital, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2008.