A Comparison of BNP Levels Using the Nexfin Device in Healthy Pregnant and Preeclamptic Women

January 26, 2018 updated by: Afshan B. Hameed, M.D., University of California, Irvine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Department of OBGYN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

33 healthy controls and 33 subjects diagnosed with preeclampsia (mild and severe).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Subjects
Measurement of hemodynamic levels (BNP) of healthly term subjects using the Nexfin sphygmomanometer device.
Device: Sphygmomanometer
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.
Other Names:
  • Nextfin
Preeclamptic Subjects
Measurement of hemodynamic levels (BNP) of preeclamptic subjects using Nexfin sphygmomanometer device.
Device: Sphygmomanometer
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.
Other Names:
  • Nextfin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One hospital visit (duration 30 minutes).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Statistical Correlation For Normotensive and Preeclamptic Subjects
Time Frame: One hospital visit (duration 30 minutes).
Composite Statistical Correlation are defined by systolic (SBP) and diastolic (DBP) levels.
One hospital visit (duration 30 minutes).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Afshan Hameed, MD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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