Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
41 participants
OBSERVATIONAL
2023-08-21
2025-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normotensive
Normotensive pregnant patients beyond the first trimester with systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg
Blood pressure measurement
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
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
Blood pressure measurement
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
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
Blood pressure measurement
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
Interventions
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Blood pressure measurement
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
Eligibility Criteria
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Inclusion Criteria
1. Able to provide informed consent
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)
18 Years
FEMALE
Yes
Sponsors
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AtCor Medical, Inc.
INDUSTRY
Mount Carmel Health System
OTHER
Responsible Party
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Robin Driver
Principal Investigator
Locations
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Mount Carmel East
Columbus, Ohio, United States
Countries
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Other Identifiers
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230608-6
Identifier Type: -
Identifier Source: org_study_id
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