Pregnancy RelatedNCT03046784
Non-invasive Haemodynamic Monitoring in Pregnancy
An observational study of Pregnancy Related and Cardiac Output, High, run by Hospital Nord at 1 site in France.
Trial summary
This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Cardiac Output, High, Haemodynamic Instability
- What is being tested?
- haemodynamic evaluation
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 31 May 2017
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-labouring term pregmant women in their third trimester
Who may be able to join
- third trimester of pregnancy
- Non-labouring pregnant women
- accepting study
Who cannot join
- refusal of study
- first or second trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Haemodynamic Monitoring in Pregnancy : Comparison Between Ultrasound and Nexfin Technology
This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic
- Being tested
- haemodynamic evaluation
- Medical subject headings
- Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haemodynamic evaluationOther
continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women in third trimester | Non-labouring pregnant women hospitalised during their third trimester of pregnancy has an haemodynamic evaluation with Nexfin technology and transthoracic cardiac ultrasonography.
Evaluation is performed in two positions : dorsal decubitus and left lateral decubitus. Receives: Other: haemodynamic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output measure
Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference.
Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startJan 2017
- Primary completion31 Mar 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marc LEONE, Hospital Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046784
- Sponsor's protocol ID
- darnord2017-01
- Status last verified
- Apr 2020
- First submitted
- 27 Jan 2017
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094.
PubMed 27199309Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.
PubMed 23059960
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Haemodynamic Monitoring in Pregnancy : Comparison Between Ultrasound and Nexfin Technology
- ClinicalTrials.gov ID
- NCT03046784
- Acronym / sponsor ID
- darnord2017-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital NordUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women in third trimester | – | Other: haemodynamic evaluationNon-labouring pregnant women hospitalised during their third trimester of pregnancy has an haemodynamic evaluation with Nexfin technology and transthoracic cardiac ultrasonography. Evaluation is performed in two positions : dorsal decubitus and left lateral decubitus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-labouring term pregmant women in their third trimester
Key inclusion criteria (3 listed)
- third trimester of pregnancy
- Non-labouring pregnant women
- accepting study
Key exclusion criteria (2 listed)
- refusal of study
- first or second trimester of 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 |
|---|---|---|
| haemodynamic evaluationcontinous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber. | Other | Pregnant women in third trimester |
Primary outcome
Cardiac output measure
Time frame: 30 minutes
Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference. Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min)
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 22 Apr 2020.
- Background: PubMed 27199309Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094.
- Background: PubMed 23059960Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.
- 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 Pregnancy Related and Cardiac Output, High, run by Hospital Nord at 1 site in France.
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 22 Apr 2020. 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 France. 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?
Cardiac output measure (time frame: 30 minutes). 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 NCT03046784, which also lists 2 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 22 Apr 2020.