PreeclampsiaNCT02527018
A Comparison of BNP Levels Using the Nexfin Device in Healthy Pregnant and Preeclamptic Women
An observational study of Preeclampsia and Maternal, run by University of California, Irvine at 1 site in United States.
Trial summary
Primary Endpoint: Quantify the hemodynamic changes in preeclampsia using the non-invasive Nexfin device. Secondary Endpoint: Determine if measurable hemodynamic changes are statistically correlated with B-type natriuretic peptide (BNP) levels. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Maternal, Hypertension
- What is being tested?
- Sphygmomanometer
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 33 healthy controls and 33 subjects diagnosed with preeclampsia (mild and severe).
Who may be able to join
- Pregnant women aged (x> or =18) with or without preeclampsia.
- Subjects with preeclampsia must have either mild or severe preeclampsia
- Healthy subjects should be normotensive
- Gestational age between 28 weeks to 40 0/7 weeks
Who cannot join
- Pregnant women aged (x<18)
- Pregnant women with multiple gestations
- Diagnosis of cardiac disease
- Diagnosis of vascular disease
- Diagnosis of end stage renal disease
- Subjects in active labor
- Diagnosis of Systemic Lupus Erythematosus or any other autoimmune disease
- Fetus' known to have age abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Department of OBGYN
Orange, California, 92868
About this study
Official title: A Comparison of B Type Natriuretic Peptide Levels and Hemodynamics Using the Nexfin Device in Healthy Pregnant and Preeclamptic Women - A Pilot Study
Primary Endpoint: Quantify the hemodynamic changes in preeclampsia using the non-invasive Nexfin device.
Secondary Endpoint: Determine if measurable hemodynamic changes are statistically correlated with B-type natriuretic peptide (BNP) levels.
Read the detailed description
Hypertensive disorders of pregnancy including preeclampsia are the leading cause of pregnancy related mortality in the United States. Timely and appropriate management of hypertensive disorders of pregnancy is critical to prevent complications such as kidney failure, HELLP syndrome, disseminated intravascular coagulation, placental abruption, intrauterine fetal demise, intracranial bleed, coma and death. (HELLP syndrome is a group of symptoms that occur inpregnant women who have: H -- hemolysis (the breakdown of red blood cells); EL -- elevated liver enzymes; LP -- low platelet count.) Hypertensive disorders of pregnancy include gestational hypertension (HTN), chronic HTN, preeclampsia and preexisting HTN with superimposed preeclampsia.
Hypertensive disorders may also lead to significant maternal and/or fetal morbidity. Based on the severity of the disease process and gestational age of the fetus, decision needs to be made whether to proceed with immediate delivery or continue expectant management. Meanwhile, maintenance of optimal blood pressure, blood volume, and cardiac output are recommended to preserve placental perfusion and to prevent unfavorable maternal and/or fetal outcomes.
Previous studies have demonstrated blood flow differences in pregnancies complicated by preeclampsia vs. healthy pregnant women evidenced by decreased arterial compliance, increased systemic vascular resistance and after load, and changes in blood volume and cardiac output. Additionally, various serum markers have been tried to identify women with preeclampsia. B-Type natriuretic peptide (BNP) has been consistently shown to be elevated in preeclampsia, and serves as a marker of heart function and intra vascular volume status.
Continuous hemodynamic monitoring may play a crucial role in timely management of these patients with severe disease due to the dynamic nature of the disease process. Existing methods are not preferred in pregnancy due to their invasive nature, and there is lack of validated non-invasive means to provide real time information on various hemodynamic parameters including cardiac output in these critically ill pregnant women.
Among new cardiac monitoring devices, the Nexfin device (BMEYE, Amsterdam, Netherlands) has recently been introduced. Nexfin device is a device approved by the Food and Drug Administration (FDA) as a non-invasive reliable method of continuous measuring arterial blood pressure in pregnant women. However there are no preliminary data on preeclamptic patients using this device. The standard of care is to use a sphygmomanometer for blood pressure monitoring. Additionally there are no studies comparing the hemodynamics of healthy and preeclamptic women using Nexfin device. Nexfin is thought to be superior over other available non-invasive methods as it is a safe and a considerably accurate method. Nexfin provides continuous blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance and left ventricular contractility indices.
The study aims to determine if the non-invasive Nexfin device can be used to reliably distinguish hemodynamics in preeclamptic vs. healthy pregnant women with singleton pregnancies along with use of BNP levels. Investigators aim to recruit 33 healthy controls and 33 subjects diagnosed with preeclampsia (mild and severe). Subject's systolic and diastolic blood pressures will be measured using both the Nexfin device and a standard sphygmomanometer (blood pressure meter). Additionally hemodynamic measure such as: heart rate, cardiac output, stroke volume, systemic vascular resistance, and left ventricular contractility will be recorded using the Nexfin device. Investigators will perform a blood draw to measure BNP levels as an additional assessment of the hemodynamic changes in the two groups.
- Conditions
- Preeclampsia, Maternal, Hypertension, Pregnancy
- Being tested
- Sphygmomanometer
- Keywords
- OBGYN, Nexfin, Hypertensive, Hemodynamic
- Medical subject headings
- Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SphygmomanometerDevice
Also called Nextfin
Non-invasive reliable method of continuous measuring arterial blood pressure in pregnant women. Nextfin provides continuous blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance and left ventricular contractility indices.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Measurement of hemodynamic levels (BNP) of healthly term subjects using the Nexfin sphygmomanometer device. Receives: Device: Sphygmomanometer | |
| Preeclamptic Subjects | Measurement of hemodynamic levels (BNP) of preeclamptic subjects using Nexfin sphygmomanometer device. Receives: Device: Sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Hemodynamic Preeclamptic Changes
Composite Changes are defined by volume overload (mL), higher B-type natriuretic peptide levels pg/mL, higher blood pressure or cardiac output (mm / Hg).
Measured: One hospital visit (duration 30 minutes).
Secondary outcomes (1)
Composite Statistical Correlation For Normotensive and Preeclamptic Subjects
Composite Statistical Correlation are defined by systolic (SBP) and diastolic (DBP) levels.
Measured: One hospital visit (duration 30 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afshan B. Hameed, M.D., University of California, Irvine
- Investigators
- Afshan Hameed, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527018
- Sponsor's protocol ID
- 2014-1232
- Status last verified
- Jan 2018
- First submitted
- 29 Jul 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of B Type Natriuretic Peptide Levels and Hemodynamics Using the Nexfin Device in Healthy Pregnant and Preeclamptic Women - A Pilot Study
- ClinicalTrials.gov ID
- NCT02527018
- Acronym / sponsor ID
- 2014-1232
- Conditions
- Preeclampsia, Maternal, Hypertension, Pregnancy
- Keywords
- OBGYN, Nexfin, Hypertensive, Hemodynamic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 18 Aug 2015 (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.
Primary Endpoint: Quantify the hemodynamic changes in preeclampsia using the non-invasive Nexfin device.
Secondary Endpoint: Determine if measurable hemodynamic changes are statistically correlated with B-type natriuretic peptide (BNP) levels.
Detailed description
Hypertensive disorders of pregnancy including preeclampsia are the leading cause of pregnancy related mortality in the United States. Timely and appropriate management of hypertensive disorders of pregnancy is critical to prevent complications such as kidney failure, HELLP syndrome, disseminated intravascular coagulation, placental abruption, intrauterine fetal demise, intracranial bleed, coma and death. (HELLP syndrome is a group of symptoms that occur inpregnant women who have: H -- hemolysis (the breakdown of red blood cells); EL -- elevated liver enzymes; LP -- low platelet count.) Hypertensive disorders of pregnancy include gestational hypertension (HTN), chronic HTN, preeclampsia and preexisting HTN with superimposed preeclampsia.
Hypertensive disorders may also lead to significant maternal and/or fetal morbidity. Based on the severity of the disease process and gestational age of the fetus, decision needs to be made whether to proceed with immediate delivery or continue expectant management. Meanwhile, maintenance of optimal blood pressure, blood volume, and cardiac output are recommended to preserve placental perfusion and to prevent unfavorable maternal and/or fetal outcomes.
Previous studies have demonstrated blood flow differences in pregnancies complicated by preeclampsia vs. healthy pregnant women evidenced by decreased arterial compliance, increased systemic vascular resistance and after load, and changes in blood volume and cardiac output. Additionally, various serum markers have been tried to identify women with preeclampsia. B-Type natriuretic peptide (BNP) has been consistently shown to be elevated in preeclampsia, and serves as a marker of heart function and intra vascular volume status.
Continuous hemodynamic monitoring may play a crucial role in timely management of these patients with severe disease due to the dynamic nature of the disease process. Existing methods are not preferred in pregnancy due to their invasive nature, and there is lack of validated non-invasive means to provide real time information on various hemodynamic parameters including cardiac output in these critically ill pregnant women.
Among new cardiac monitoring devices, the Nexfin device (BMEYE, Amsterdam, Netherlands) has recently been introduced. Nexfin device is a device approved by the Food and Drug Administration (FDA) as a non-invasive reliable method of continuous measuring arterial blood pressure in pregnant women. However there are no preliminary data on preeclamptic patients using this device. The standard of care is to use a sphygmomanometer for blood pressure monitoring. Additionally there are no studies comparing the hemodynamics of healthy and preeclamptic women using Nexfin device. Nexfin is thought to be superior over other available non-invasive methods as it is a safe and a considerably accurate method. Nexfin provides continuous blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance and left ventricular contractility indices.
The study aims to determine if the non-invasive Nexfin device can be used to reliably distinguish hemodynamics in preeclamptic vs. healthy pregnant women with singleton pregnancies along with use of BNP levels. Investigators aim to recruit 33 healthy controls and 33 subjects diagnosed with preeclampsia (mild and severe). Subject's systolic and diastolic blood pressures will be measured using both the Nexfin device and a standard sphygmomanometer (blood pressure meter). Additionally hemodynamic measure such as: heart rate, cardiac output, stroke volume, systemic vascular resistance, and left ventricular contractility will be recorded using the Nexfin device. Investigators will perform a blood draw to measure BNP levels as an additional assessment of the hemodynamic changes in the two groups.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Device: SphygmomanometerMeasurement of hemodynamic levels (BNP) of healthly term subjects using the Nexfin sphygmomanometer device. |
| Preeclamptic Subjects | – | Device: SphygmomanometerMeasurement of hemodynamic levels (BNP) of preeclamptic subjects using Nexfin sphygmomanometer device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 33 healthy controls and 33 subjects diagnosed with preeclampsia (mild and severe).
Key inclusion criteria (4 listed)
- Pregnant women aged (x> or =18) with or without preeclampsia.
- Subjects with preeclampsia must have either mild or severe preeclampsia
- Healthy subjects should be normotensive
- Gestational age between 28 weeks to 40 0/7 weeks
Key exclusion criteria (8 listed)
- Pregnant women aged (x<18)
- Pregnant women with multiple gestations
- Diagnosis of cardiac disease
- Diagnosis of vascular disease
- Diagnosis of end stage renal disease
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 |
|---|---|---|
| SphygmomanometerAlso: NextfinNon-invasive reliable method of continuous measuring arterial blood pressure in pregnant women. Nextfin provides continuous blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance and left ventricular contractility indices. | Device | Healthy Subjects, Preeclamptic Subjects |
Primary outcome
Composite Hemodynamic Preeclamptic Changes
Time frame: One hospital visit (duration 30 minutes).
Composite Changes are defined by volume overload (mL), higher B-type natriuretic peptide levels pg/mL, higher blood pressure or cardiac output (mm / Hg).
1 secondary outcome
Composite Statistical Correlation For Normotensive and Preeclamptic Subjects
Time frame: One hospital visit (duration 30 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 30 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Afshan Hameed, MD principal investigator
University of California, Irvine
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 Preeclampsia and Maternal, run by University of California, Irvine 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 4 inclusion and 8 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 30 Jan 2018. 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?
Composite Hemodynamic Preeclamptic Changes (time frame: One hospital visit (duration 30 minutes).). 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 30 Jan 2018.