A Comparison of BNP Levels Using the Nexfin Device in Healthy Pregnant and Preeclamptic Women
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Women's Studies, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2018 |
| Start Date: | November 2014 |
| End Date: | October 2017 |
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.
Nexfin device.
Secondary Endpoint: Determine if measurable hemodynamic changes are statistically correlated
with B-type natriuretic peptide (BNP) levels.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
