Hemodynamic Changes in PregnancyNCT01861132
Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women
An observational study of Hemodynamic Changes in Pregnancy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hemodynamic Changes in Pregnancy
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Feb 2014
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Healthy singleton pregnancies at term scheduled for cesarean delivery under spinal anesthesia
Who may be able to join
- Healthy singleton pregnancies at term scheduled for cesarean delivery
Who cannot join
- Twins, or multiple gestation, pre-eclampsia, gestational hypertension
- Reynaud phenomenon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Non-invasive Monitoring of Blood Pressure and Cardiac Output in Healthy Pregnant Women During Cesarean Section
Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women.
Read the detailed description
Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO Plus. Both comparison of absolute values and the two different devices trending abilities will be analyzed.
- Conditions
- Hemodynamic Changes in Pregnancy
- Keywords
- Pregnancy, cesarean delivery, blood pressure, cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | Healthy pregnant women for C-section under spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Comparison of beat-to-beat data
Measured: 15 minutes
Secondary outcomes (1)
Cardiac output
Comparing beat-to-beat data of cardiac output
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic Changes in PregnancyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861132
- Sponsor's protocol ID
- NexValid13
- Status last verified
- Jun 2021
- First submitted
- 21 May 2013
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Omenas IN, Tronstad C, Rosseland LA. Accuracy and trending abilities of finger plethysmographic blood pressure and cardiac output compared to invasive measurements during caesarean delivery in healthy women: an observational study. BMC Anesthesiol. 2020 Jun 27;20(1):157. doi: 10.1186/s12871-020-01078-8.
PubMed 32593297
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non-invasive Monitoring of Blood Pressure and Cardiac Output in Healthy Pregnant Women During Cesarean Section
- ClinicalTrials.gov ID
- NCT01861132
- Acronym / sponsor ID
- NexValid13
- Conditions
- Hemodynamic Changes in Pregnancy
- Keywords
- Pregnancy, cesarean delivery, blood pressure, cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 May 2013 (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.
Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women.
Detailed description
Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO Plus. Both comparison of absolute values and the two different devices trending abilities will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | – | –Healthy pregnant women for C-section under spinal anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy singleton pregnancies at term scheduled for cesarean delivery under spinal anesthesia
Key inclusion criteria (1 listed)
- Healthy singleton pregnancies at term scheduled for cesarean delivery
Key exclusion criteria (2 listed)
- Twins, or multiple gestation, pre-eclampsia, gestational hypertension
- Reynaud phenomenon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic blood pressure
Time frame: 15 minutes
Comparison of beat-to-beat data
1 secondary outcome
Cardiac output
Time frame: 15 minutes
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 14 Jun 2021.
- Results publication: PubMed 32593297Omenas IN, Tronstad C, Rosseland LA. Accuracy and trending abilities of finger plethysmographic blood pressure and cardiac output compared to invasive measurements during caesarean delivery in healthy women: an observational study. BMC Anesthesiol. 2020 Jun 27;20(1):157. doi: 10.1186/s12871-020-01078-8.
Related trials for Hemodynamic Changes in Pregnancy
Not yet recruitingObservational study
Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-Eclampsia
Pre-eclampsia, Pregnancy
Active, not recruitingObservational study
SD-OCT Measurement of the Human Retina in Pregnancy With Pre-existing or De Novo Hypertension and Without Hypertension
Pregnancy Induced Hypertension, Pregnancy Related
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 Hemodynamic Changes in Pregnancy, run by Oslo University Hospital at 1 site in Norway.
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 1 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 14 Jun 2021. 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 Norway. 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?
Systolic blood pressure (time frame: 15 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 NCT01861132, which also lists 1 linked publication.
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 14 Jun 2021.