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

NCT02527018 | Completed DMC

• 1 other identifier: 2014-1232
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia; Maternal; Hypertension; Pregnancy

Keywords

OBGYN; Nexfin; Hypertensive; Hemodynamic

Outcome Measures

Primary Outcomes (1)

• 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).

  One hospital visit (duration 30 minutes).

Secondary Outcomes (1)

• Composite Statistical Correlation For Normotensive and Preeclamptic Subjects

  One hospital visit (duration 30 minutes).

Study Arms (2)

Healthy Subjects

Measurement of hemodynamic levels (BNP) of healthly term subjects using the Nexfin sphygmomanometer device.

Device: Sphygmomanometer

Preeclamptic Subjects

Measurement of hemodynamic levels (BNP) of preeclamptic subjects using Nexfin sphygmomanometer device.

Device: Sphygmomanometer

Interventions

Sphygmomanometer DEVICE

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.

Also known as: Nextfin

Healthy Subjects; Preeclamptic Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Department of OBGYN

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Sphygmomanometers

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Officials

• Afshan Hameed, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical OBGYN / Medical Director Obstetrical Services for OBGYN

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 18, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: October 1, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)