Pregnancy RelatedNCT06002971
CONNEQT Pulse Validation Study
An observational study of Pregnancy Related and Pre-Eclampsia, run by Mount Carmel Health System at 1 site in United States.
Trial summary
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pre-Eclampsia, Gestational Hypertension
- What is being tested?
- Blood pressure measurement
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 3 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.
All Groups:
- Able to provide informed consent
- Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
- 18 years of age, or older
Normotensive:
- Systolic blood pressure <140 mmHg (18,66 kPa) and diastolic blood pressure <90 mmHg (12 kPa)
Hypertensive:
- Without proteinuria >300 mg in 24 h; and
- With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)
Pre-Eclampsia:
- With proteinuria >300 mg in 24 h; and
- With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.
Read the detailed description
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.
- Conditions
- Pregnancy Related, Pre-Eclampsia, Gestational Hypertension
- Being tested
- Blood pressure measurement
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementDevice
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive | Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg Receives: Device: Blood pressure measurement | |
| Hypertensive | Hypertensive pregnant patients beyond the first trimester:
i) without proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg Receives: Device: Blood pressure measurement | |
| Pre-Eclampsia | Pre-eclampsia patients beyond the first trimester:
i) with proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg Receives: Device: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.
Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.
Measured: Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start21 Aug 2023
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Why it stopped: Unable to recruit intended patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Collaborators
- AtCor Medical, Inc.
- Responsible party
- Principal investigator, Robin Driver, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002971
- Sponsor's protocol ID
- 230608-6
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population
- ClinicalTrials.gov ID
- NCT06002971
- Acronym / sponsor ID
- 230608-6
- Conditions
- Pregnancy Related, Pre-Eclampsia, Gestational Hypertension
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit intended patient population
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Collaborators
- AtCor Medical, Inc.
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- 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 validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.
Detailed description
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normotensive | – | Device: Blood pressure measurementNormotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg |
| Hypertensive | – | Device: Blood pressure measurementHypertensive pregnant patients beyond the first trimester: i) without proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg |
| Pre-Eclampsia | – | Device: Blood pressure measurementPre-eclampsia patients beyond the first trimester: i) with proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.
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 |
|---|---|---|
| Blood pressure measurementSerial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2. | Device | Hypertensive, Normotensive, Pre-Eclampsia |
Primary outcome
Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.
Time frame: Up to 60 minutes
Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.
Results and safety
The study was stopped early (reason given: Unable to recruit intended patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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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?
An observational study of Pregnancy Related and Pre-Eclampsia, run by Mount Carmel Health System 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?
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: stopped early, as of the sponsor's last update on 5 Mar 2026. 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 stopped early (reason given: Unable to recruit intended patient population). Results are not available in the source record.
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?
Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings. (time frame: Up to 60 minutes). 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 5 Mar 2026.