ClinicalTrials.gg
TerminatedNCT06002971Updated Mar 5, 2026

CONNEQT Pulse Validation Study

An observational study in Pregnancy Related, Pre-Eclampsia and Gestational Hypertension, sponsored by Mount Carmel Health System. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Mount Carmel Health System · Observational

Why this study was terminated
Unable to recruit intended patient population
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
41
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 228 studies in Pre-Eclampsia with a site in United States — 60 open to participants now, 76 under way, 6 of them phase 3. Pre-Eclampsia · United States.

Enrollment
56th of 69
41 · median 125
Started
2023
with 16 others
Observational
69 of 228
14 open now
Registered
167th of 228
by date

Among the 228 studies in Pre-Eclampsia with a site in United States, this one is the 56th largest by enrollment of the 69 observational ones, is one of 17 that started in 2023, is one of 69 observational ones, and was the 167th registered.

By phase

228 studies; the count open now beside each. This study's row is marked.

No phase71 · 17 open
Observationalthis study69 · 14 open
Phase 431 · 11 open
Phase 121 · 6 open
Phase 218 · 7 open
Phase 312 · 4 open
Phase 1/23 · 1 open
Phase 2/33 · 0 open

By the year they started

First in 2000; this study’s year is marked. 17 started in 2023.

Size and results

Median enrollment 89 across the 159 interventional studies, 125 across the 69 observational. Of the 126 that completed or were terminated, 54 (43%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 228 studies in Pre-Eclampsia with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Pregnancy Related
  • Pre-Eclampsia
  • Gestational Hypertension
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.

Eligibility criteria

All Groups:

  1. Able to provide
  2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
  3. 18 years of age, or older

Normotensive:

1. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa)

Hypertensive:

  1. Without proteinuria >300 mg in 24 h; and
  2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)

Pre-Eclampsia:

  1. With proteinuria >300 mg in 24 h; and
  2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
41 participants (actual)
Patient registry
No

Groups and cohorts

  • Normotensive

    Normotensive pregnant patients beyond the first trimester with systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg

    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

    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

    Device: Blood pressure measurement

Interventions

  • DeviceBlood pressure measurement

    Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 60 minutes

07

Study locations

1 site
  • Mount Carmel East
    Columbus, Ohio 43213, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2023 to primary completion in Jun 2025, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2023
First posted
Aug 21, 2023
StartActual
Aug 21, 2023
Primary completionActual
Jun 3, 2025
CompletionActual
Jun 3, 2025
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06002971
Lead sponsor
Mount Carmel Health System
Collaborators
AtCor Medical, Inc.
Responsible party
Robin Driver (Principal Investigator, Mount Carmel Health System) — Principal investigator
First posted
Aug 21, 2023
Start date
Aug 21, 2023
Primary completion
Jun 3, 2025
Completion
Jun 3, 2025
Last update
Mar 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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