Pre EclampsiaNCT02319174

Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women

A study testing Sphygmo in people with Pre Eclampsia, run by William Marsh Rice University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pre Eclampsia
What is being tested?: Sphygmo
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Jun 2015to 4 Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Pregnant women receiving antenatal care at the UT OB/GYN clinic.
Over the age of 18

Who cannot join

Women under the age of 18
Women unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center Houston
Houston, Texas, 77030

Other trials in United States

About this study

The purpose of the study is to help make a lower cost automatic blood pressure monitor device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood pressure monitoring is limited or not available. The study will compare this low cost device to a commercially available system used for pre-eclamptic women in many United States hospitals that the investigators will be bringing to Malawi as a part of this study.

The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use.

70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at University of Texas Health Science Center Houston. Patient arm circumference will be measured with measurement tape.

They will be seated upright in a comfortable chair with arm at heart level and an arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm.

The cuff will be inflated and then deflated until measurement concludes. Heart rate will be measured with tactile arterial palpation.The process will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.

Read the detailed description

The research team has developed an automatic blood pressure monitor to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited. This study aims to evaluate the accuracy of the device's blood pressure measurements in pregnant and pre-eclamptic women. This device must be evaluated with the above described population because blood pressure measurement devices are known to perform differently in pregnant and pre-eclamptic women than in normal healthy adults.

This study will take place at the University of Texas Health Science Center (UTHSC) where up to 70 subjects will be recruited to participate during their regularly scheduled antenatal care checkups.

The Patient arm circumference will be measured with measurement tape.
The Patient will be seated upright in a comfortable chair with arm at heart level.
An arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm of the patient over the brachial artery.
Cuff will be inflated to ~200 mmHg and then deflated until measurement concludes.
Heart rate will be measured with Tactile Arterial Palpation.
Steps 3-4 will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

Conditions: Pre Eclampsia
Being tested: Sphygmo
Medical subject headings: Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SphygmoDevice
A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals

Study groups in NCT02319174
Study group	Role	What they receive
Sphygmo	Experimental	All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. Receives: Device: Sphygmo

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Blood Pressure Readings by Sphygmo
Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.
Measured: Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.
The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (A/A) with the validation data from this study.
Measured: Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20154 Nov 2016

First posted18 Dec 2014 (estimated)
Study startJun 2015
Primary completionJun 2015
Study completion4 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Pre EclampsiaStudies 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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02319174
Sponsor's protocol ID: 14-082F-B
Status last verified: Dec 2018
First submitted: 10 Dec 2014
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Natarajan P, Shennan AH, Penny J, Halligan AW, de Swiet M, Anthony J. Comparison of auscultatory and oscillometric automated blood pressure monitors in the setting of preeclampsia. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1203-10. doi: 10.1016/s0002-9378(99)70109-2.
PubMed 10561646
Turner JA. Diagnosis and management of pre-eclampsia: an update. Int J Womens Health. 2010 Sep 30;2:327-37. doi: 10.2147/IJWH.S8550.
PubMed 21151680
Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. doi: 10.1016/S0140-6736(00)03599-6.
PubMed 11213110
Magee LA, Abalos E, von Dadelszen P, Sibai B, Easterling T, Walkinshaw S; CHIPS Study Group. How to manage hypertension in pregnancy effectively. Br J Clin Pharmacol. 2011 Sep;72(3):394-401. doi: 10.1111/j.1365-2125.2011.04002.x.
PubMed 21545480
De Greeff A, Ghosh D, Anthony J, Shennan A. Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia. Hypertens Pregnancy. 2010 Jan;29(2):198-205. doi: 10.3109/10641950902968650.
PubMed 20367507
O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, Bland M, Coats A, Atkins N. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993 Jun;11(6):677-9. doi: 10.1097/00004872-199306000-00013. No abstract available.
PubMed 8397248

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
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Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia

All Pre Eclampsia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women
ClinicalTrials.gov ID: NCT02319174
Acronym / sponsor ID: 14-082F-B
Conditions: Pre Eclampsia
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: William Marsh Rice UniversityUniversity, hospital or other
Collaborators: The University of Texas Health Science Center, Houston
Study start: Jun 2015
Primary completion: Jun 2015 (actual)
Study completion: 4 Nov 2016 (actual)
First posted: 18 Dec 2014 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use.

The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.

Detailed description

This study will take place at the University of Texas Health Science Center (UTHSC) where up to 70 subjects will be recruited to participate during their regularly scheduled antenatal care checkups.

The Patient arm circumference will be measured with measurement tape.
The Patient will be seated upright in a comfortable chair with arm at heart level.
An arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm of the patient over the brachial artery.
Cuff will be inflated to ~200 mmHg and then deflated until measurement concludes.
Heart rate will be measured with Tactile Arterial Palpation.
Steps 3-4 will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sphygmo	Experimental	Device: SphygmoAll subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Pregnant women receiving antenatal care at the UT OB/GYN clinic.
Over the age of 18

Key exclusion criteria (2 listed)

Women under the age of 18
Women unable to provide informed consent

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
SphygmoA team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals	Device	Sphygmo

Primary outcome

Accuracy of Blood Pressure Readings by Sphygmo
Time frame: Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes
Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.
Time frame: Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes
The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (A/A) with the validation data from this study.

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sphygmo	43	42

Primary outcome: Accuracy of Blood Pressure Readings by Sphygmo

Time frame: Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes. Mean (Standard Deviation). Unit: mmHg

Measure	Sphygmo n = 18	Dinamap n = 18
Systolic Mean	114.5 (10.9)	115.6 (12.5)
Diastolic Mean	65.7 (8.3)	66.3 (10.6)

Population analysed: Of 41 participants who completed the study, 5 participants were excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement. This left 36 participants, 18 of which were used to train the device. The data presented here is from the remaining 18 participants.

Primary outcome: Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.

Time frame: Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes. Number. Unit: percentage of measurements in range

Measure	Sphygmo n = 18
Systolic Difference <5 mmHg	67
Systolic Difference <10 mmHg	85
Systolic Difference <15 mmHg	98
Diastolic Difference <5 mmHg	70
Diastolic Difference <10 mmHg	89
Diastolic Difference <15 mmHg	98

Adverse events

Time frame: 1 year and 5 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sphygmo	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10561646Natarajan P, Shennan AH, Penny J, Halligan AW, de Swiet M, Anthony J. Comparison of auscultatory and oscillometric automated blood pressure monitors in the setting of preeclampsia. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1203-10. doi: 10.1016/s0002-9378(99)70109-2.
Background: PubMed 21151680Turner JA. Diagnosis and management of pre-eclampsia: an update. Int J Womens Health. 2010 Sep 30;2:327-37. doi: 10.2147/IJWH.S8550.
Background: PubMed 11213110Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. doi: 10.1016/S0140-6736(00)03599-6.
Background: PubMed 21545480Magee LA, Abalos E, von Dadelszen P, Sibai B, Easterling T, Walkinshaw S; CHIPS Study Group. How to manage hypertension in pregnancy effectively. Br J Clin Pharmacol. 2011 Sep;72(3):394-401. doi: 10.1111/j.1365-2125.2011.04002.x.
Background: PubMed 20367507De Greeff A, Ghosh D, Anthony J, Shennan A. Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia. Hypertens Pregnancy. 2010 Jan;29(2):198-205. doi: 10.3109/10641950902968650.
Background: PubMed 8397248O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, Bland M, Coats A, Atkins N. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993 Jun;11(6):677-9. doi: 10.1097/00004872-199306000-00013. No abstract available.

Related trials for Pre Eclampsia

Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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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.

Rebecca R Kortum, PhD principal investigator

William Marsh Rice University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sphygmo in people with Pre Eclampsia, run by William Marsh Rice University 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 2 inclusion and 2 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 19 Dec 2018. 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?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy of Blood Pressure Readings by Sphygmo (time frame: Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes). The study lists 2 primary outcomes in all. 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 NCT02319174, which also lists 6 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 19 Dec 2018.