HypertensionNCT02823873
Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
An observational study of Hypertension, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Pulsewave oscillometric wrist cuff blood pressure monitor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant or postpartum women recruited from the antepartum, labor \& delivery, and postpartum units of the hospital.
Who may be able to join
- Pregnant or admitted to the postpartum unit
- Normotensive women - No diagnosis of hypertension
- Hypertensive women - Diagnosis of hypertensive disorder of pregnancy
Who cannot join
- Women in active labor
- Women < 18 years of age
- Non-english speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure.
Read the detailed description
The study will include a series of nine blood pressure measurements. The measurements will alternate between a gold standard auscultatory blood pressure measurement and the Pulsewave monitor.
A trained clinician will be used for gold standard measurements using an appropriately sized cuff around the upper arm, a sphygmomanometer, and a stethoscope. Systolic blood pressure is defined by the first Korotkoff sound; diastolic blood pressure is defined by the fifth Korotkoff sound.
Measurements by the Pulsewave monitor will be performed using a proprietary oscillometric wrist cuff automated by a computer tablet and software made by CloudDx Inc.
Women will be seated for 5 to 10 minutes before the first blood pressure measurement. During this time, 4 circumference measurements will be taken of the arm and wrist.
- The armpit will be measured as proximally as possible.
- The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process.
- The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease.
- The wrist will be measured approximately 2 cm proximal to the wrist flexion crease.
The first two blood pressure measurements will be used as a way to orient the subject to each device and the methods so that they are comfortable with the cuff and the process. The seven subsequent measurements will be used for analysis. There will be a 30 second to 60 second period between blood pressure measurements.
- Conditions
- Hypertension
- Being tested
- Pulsewave oscillometric wrist cuff blood pressure monitor
- Keywords
- Hypertension, Pregnant, Preeclampsia, Gestational Hypertension, Blood Pressure, Pregnant Women, Postpartum Women
- 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.
Pulsewave oscillometric wrist cuff blood pressure monitorDevice
Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive | Normotensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor. Receives: Device: Pulsewave oscillometric wrist cuff blood pressure monitor | |
| Hypertensive | Hypertensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor. Receives: Device: Pulsewave oscillometric wrist cuff blood pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements
Test measurement will be compared to standard measurements made at the same time.
Measured: Immediately after blood pressure measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
Why it stopped: Study submitted in error
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Mhyre, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823873
- Sponsor's protocol ID
- 205588
- Status last verified
- Jul 2016
- First submitted
- 16 Jun 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data will be de-identified. Data may be relevant to future studies regarding mobile health technology.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
- ClinicalTrials.gov ID
- NCT02823873
- Acronym / sponsor ID
- 205588
- Conditions
- Hypertension
- Keywords
- Hypertension, Pregnant, Preeclampsia, Gestational Hypertension, Blood Pressure, Pregnant Women, Postpartum Women
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study submitted in error
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 6 Jul 2016 (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 purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure.
Detailed description
The study will include a series of nine blood pressure measurements. The measurements will alternate between a gold standard auscultatory blood pressure measurement and the Pulsewave monitor.
A trained clinician will be used for gold standard measurements using an appropriately sized cuff around the upper arm, a sphygmomanometer, and a stethoscope. Systolic blood pressure is defined by the first Korotkoff sound; diastolic blood pressure is defined by the fifth Korotkoff sound.
Measurements by the Pulsewave monitor will be performed using a proprietary oscillometric wrist cuff automated by a computer tablet and software made by CloudDx Inc.
Women will be seated for 5 to 10 minutes before the first blood pressure measurement. During this time, 4 circumference measurements will be taken of the arm and wrist.
- The armpit will be measured as proximally as possible.
- The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process.
- The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease.
- The wrist will be measured approximately 2 cm proximal to the wrist flexion crease.
The first two blood pressure measurements will be used as a way to orient the subject to each device and the methods so that they are comfortable with the cuff and the process. The seven subsequent measurements will be used for analysis. There will be a 30 second to 60 second period between blood pressure measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normotensive | – | Device: Pulsewave oscillometric wrist cuff blood pressure monitorNormotensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor. |
| Hypertensive | – | Device: Pulsewave oscillometric wrist cuff blood pressure monitorHypertensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant or postpartum women recruited from the antepartum, labor \& delivery, and postpartum units of the hospital.
Key inclusion criteria (3 listed)
- Pregnant or admitted to the postpartum unit
- Normotensive women - No diagnosis of hypertension
- Hypertensive women - Diagnosis of hypertensive disorder of pregnancy
Key exclusion criteria (3 listed)
- Women in active labor
- Women < 18 years of age
- Non-english speakers
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 |
|---|---|---|
| Pulsewave oscillometric wrist cuff blood pressure monitorBlood pressure monitor utilizing wrist cuff administered and measured using mobile technology. | Device | Hypertensive, Normotensive |
Primary outcome
Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements
Time frame: Immediately after blood pressure measurement
Test measurement will be compared to standard measurements made at the same time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Individual participant dataSharing planned: Undecided. Data will be de-identified. Data may be relevant to future studies regarding mobile health technology.
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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.
Jill Mhyre, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Arkansas at 1 site in United States.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Jul 2016. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements (time frame: Immediately after blood pressure measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2016.