Pre-EclampsiaNCT05299229
Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements
An observational study of Pre-Eclampsia, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life… 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?
- Echocardiogrpahy and non-invasive monitoring
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2020to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with severe preeclampsia.
Who may be able to join
- BP >160 or DBP >110
- gestational age between 20-34 weeks
- singleton pregnancy
Who cannot join
- prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy
- multi-fetal pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Hospital
New Haven, Connecticut, 06510
About this study
The purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life Sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.
- Conditions
- Pre-Eclampsia
- Being tested
- Echocardiogrpahy and non-invasive monitoring
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiogrpahy and non-invasive monitoringDiagnostic test
Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.
| Study group | Role | What they receive |
|---|---|---|
| Heart and vascular function | All study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff to determine the best method of monitoring heart and vascular function in preeclampsia. Receives: Diagnostic Test: Echocardiogrpahy and non-invasive monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring
Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Measured: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring
Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia
Measured: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring
Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Measured: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring
Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring
Measured: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Change in Cardiac output (L/min) as measured by transthoracic echocardiography
Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Measured: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography
Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia
Measured: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start29 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299229
- Sponsor's protocol ID
- 2000028142
- Status last verified
- Aug 2022
- First submitted
- 13 Oct 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements
- ClinicalTrials.gov ID
- NCT05299229
- Acronym / sponsor ID
- 2000028142
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Mar 2022 (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 compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life Sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart and vascular function | – | Diagnostic Test: Echocardiogrpahy and non-invasive monitoringAll study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff to determine the best method of monitoring heart and vascular function in preeclampsia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with severe preeclampsia.
Key inclusion criteria (3 listed)
- BP >160 or DBP >110
- gestational age between 20-34 weeks
- singleton pregnancy
Key exclusion criteria (2 listed)
- prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy
- multi-fetal pregnancy
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 |
|---|---|---|
| Echocardiogrpahy and non-invasive monitoringStudy participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff. | Diagnostic test | Heart and vascular function |
Primary outcome
Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring
Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring
Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia
Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring
Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring
Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring
Change in Cardiac output (L/min) as measured by transthoracic echocardiography
Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography
Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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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 Pre-Eclampsia, run by Yale 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 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 12 Aug 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring (time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)). The study lists 6 primary outcomes in all. 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 12 Aug 2022.