Pre EclampsiaNCT02258256
Pilot Assessment of an Auto Blood Pressure Monitor
A study testing Sphygmo in people with Pre Eclampsia, run by William Marsh Rice University at 1 site in Malawi.
Trial summary
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. Read more about this study
- 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
- 11 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Mar 2015to 1 Oct 2017
- 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
- Women who have been identified as at-risk for pre-eclampsia or have been diagnosed with pre-eclampsia during a visit to QECH.
- Women who have been clinically identified to benefit from continuous blood pressure monitoring.
- Women ages 18 or older.
Who cannot join
- Pregnant women who have already developed eclampsia.
- Women under age 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Clinical Assessment of the Diagnostic Capability, Usability, and Function of an Automatic Blood Pressure Monitor for Use in the Diagnosis and Management of Pre-eclampsia in a Low-resource Hospital
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.
Read more
20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the subject and the commercially available cuff on the opposite arm. A trained research assistant and the nurse will record the blood pressure measurements and document any alarm indications made by each device. Blood pressure measurements will continue until monitoring is no longer clinically prescribed.
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 at Rice University has developed Sphygmo, 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 blood pressure monitoring is limited. This study aims to evaluate the capabilities of the device in the setting for which it was designed - a low-resource hospital.
This study will compare the Sphygmo device to a commercially available automatic blood pressure monitor that is used in pre-eclamptic women. The main objective of this study is to determine whether the Sphygmo device correctly identifies instances where blood pressure measurement meets the diagnostic criteria for mild or severe pre-eclampsia during monitoring of at-risk mothers. Additionally, this study aims to understand the frequency and type of any complications associated with use of the Sphygmo in a resource-limited clinical setting.
The study will include 20 eligible and consenting women at QECH who are clinically identified as at-risk for pre-eclampsia or have already been diagnosed with pre-eclampsia by their doctors. All participants will undergo the same protocol (monitoring with both Sphygmo and the commercially available device). First, a nurse will fit a Sphygmo device cuff on one arm of the subject and the commercially available device cuff on the opposite arm. A trained research assistant will be continuously on hand to assist the nurse in the device setup and record the blood pressure measurements and any alarm indications made by each device. Blood pressure measurements by Sphygmo and the commercially available device will continue until monitoring is no longer clinically prescribed. In addition, blood pressure will be taken via clinical auscultatory measurement with a stethoscope and aneroid gauge at regular intervals. This third method will help us confirm the accuracy of the two devices. All clinical decisions will be made according to the commercially available device's measurements.
The key results of the study will be the ability of the Sphygmo device to identify blood pressure levels corresponding to mild and severe pre-eclampsia. Additionally, the investigators will document any user errors or device malfunction. These results will provide information on the performance and ease of use of the device and will also alert the research team of any necessary changes needed for the device.
- 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 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 Measurement by Sphygmo Relative to the Clinical Standard.
Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants
Measured: Measured during a single study visit, up to 24-72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start1 Mar 2015
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
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 (5)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
- Model description
- Pregnant women will have their blood pressure measured by both the experimental device (Sphygmo ) and the gold-standard, commercial device (GE Dinamap Procare).
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Principal investigator, Rebecca Richards-Kortum, William Marsh Rice University
- Investigators
- Rebecca R Richards-Kortum, PhD, Principal investigator, William Marsh Rice UniversityRonald Mataya, MD, Principal investigator, University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258256
- Sponsor's protocol ID
- 14-082F-C
- Other IDs
- (COMREC) P.04/14/1548
- Status last verified
- Aug 2021
- First submitted
- 25 Sep 2014
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 21545480Wagner LK. Diagnosis and management of preeclampsia. Am Fam Physician. 2004 Dec 15;70(12):2317-24.
PubMed 15617295De 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 20367507Turner 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 21151680Dekker 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Assessment of the Diagnostic Capability, Usability, and Function of an Automatic Blood Pressure Monitor for Use in the Diagnosis and Management of Pre-eclampsia in a Low-resource Hospital
- ClinicalTrials.gov ID
- NCT02258256
- Acronym / sponsor ID
- 14-082F-C
- Conditions
- Pre Eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Posted 21 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 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.
20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the subject and the commercially available cuff on the opposite arm. A trained research assistant and the nurse will record the blood pressure measurements and document any alarm indications made by each device. Blood pressure measurements will continue until monitoring is no longer clinically prescribed.
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
The research team at Rice University has developed Sphygmo, 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 blood pressure monitoring is limited. This study aims to evaluate the capabilities of the device in the setting for which it was designed - a low-resource hospital.
This study will compare the Sphygmo device to a commercially available automatic blood pressure monitor that is used in pre-eclamptic women. The main objective of this study is to determine whether the Sphygmo device correctly identifies instances where blood pressure measurement meets the diagnostic criteria for mild or severe pre-eclampsia during monitoring of at-risk mothers. Additionally, this study aims to understand the frequency and type of any complications associated with use of the Sphygmo in a resource-limited clinical setting.
The study will include 20 eligible and consenting women at QECH who are clinically identified as at-risk for pre-eclampsia or have already been diagnosed with pre-eclampsia by their doctors. All participants will undergo the same protocol (monitoring with both Sphygmo and the commercially available device). First, a nurse will fit a Sphygmo device cuff on one arm of the subject and the commercially available device cuff on the opposite arm. A trained research assistant will be continuously on hand to assist the nurse in the device setup and record the blood pressure measurements and any alarm indications made by each device. Blood pressure measurements by Sphygmo and the commercially available device will continue until monitoring is no longer clinically prescribed. In addition, blood pressure will be taken via clinical auscultatory measurement with a stethoscope and aneroid gauge at regular intervals. This third method will help us confirm the accuracy of the two devices. All clinical decisions will be made according to the commercially available device's measurements.
The key results of the study will be the ability of the Sphygmo device to identify blood pressure levels corresponding to mild and severe pre-eclampsia. Additionally, the investigators will document any user errors or device malfunction. These results will provide information on the performance and ease of use of the device and will also alert the research team of any necessary changes needed for the device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnant women will have their blood pressure measured by both the experimental device (Sphygmo ) and the gold-standard, commercial device (GE Dinamap Procare).
| 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 (3 listed)
- Women who have been identified as at-risk for pre-eclampsia or have been diagnosed with pre-eclampsia during a visit to QECH.
- Women who have been clinically identified to benefit from continuous blood pressure monitoring.
- Women ages 18 or older.
Key exclusion criteria (2 listed)
- Pregnant women who have already developed eclampsia.
- Women under age 18.
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 Measurement by Sphygmo Relative to the Clinical Standard.
Time frame: Measured during a single study visit, up to 24-72 hours.
Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 15617295Wagner LK. Diagnosis and management of preeclampsia. Am Fam Physician. 2004 Dec 15;70(12):2317-24.
- 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 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.
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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 Richards-Kortum, PhD principal investigator
William Marsh Rice University
Ronald Mataya, MD principal investigator
University of Malawi
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 Malawi.
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 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 10 Aug 2021. 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 Malawi. 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 21 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 Measurement by Sphygmo Relative to the Clinical Standard. (time frame: Measured during a single study visit, up to 24-72 hours.). 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 NCT02258256, which also lists 5 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 10 Aug 2021.