Vanderbilt Clinical Trials

Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia

Purpose

The study will compare agreement of invasive blood pressure measurements with non-invasive blood pressure measurements measured with a conical blood pressure and large standard upper arm rectangular cuff in morbidly obese severely hypertensive (systolic blood pressure > 160 mmHg) parturients.

Conditions

Pre-Eclampsia
Morbid Obesity
Parturient
Blood Pressure

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

Written, signed and dated informed consent - ≥ 18 years of age - BMI >40 kg/m2 - Has a clinically indicated radial artery line already in situ or who agree to placement of an arterial line - Systolic blood pressure >160 mm Hg - Gestational age greater than or equal to 24 weeks - Parturients admitted for induction of labor

Exclusion Criteria

Parturients admitted in labor

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A: Conical then Cylindrical	BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring	Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff Device: Non-invasive BP recording with traditional cylindrical BP cuff Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff Other: Direct invasive arterial pressure Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements
Active Comparator Arm B: Cylindrical then Conical	BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring	Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff Device: Non-invasive BP recording with traditional cylindrical BP cuff Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff Other: Direct invasive arterial pressure Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements

More Details

Status: Terminated
Sponsor: Vanderbilt University Medical Center

Study Contact

Detailed Description

A morbidly obese [Body Mass Index (BMI) ≥ 40 kg/m2] pregnant woman is at singular risk for all the complications of pregnancy, most notably preeclampsia (PE). Furthermore a woman who is already chronically hypertensive is likely to develop superimposed PE . Uncontrolled systolic hypertension in pregnancy prompts placental abruption, hemorrhagic stroke, and systolic or diastolic heart failure. Accurate blood pressure measurement is therefore a prerequisite to controlling dangerously high systolic blood pressure (SBP) to enable labor and delivery to be conducted safely in association with PE. Precise SBP measurement is also a precondition for clinically testing hypotheses concerning the existence of druggable targets that will allow prolongation of pregnancy in the face of severe PE and /or intra-uterine growth restriction (IUGR) remote from term. Oscillometric noninvasive blood pressure (NIBP) measurement is the customary standard blood pressure monitoring method most often used in the labor suite and obstetric operating room today. For this purpose a rectangular, cylindrical blood pressure (BP) cuff placed on the upper arm is connected to an oscillometric blood pressure device. Yet inaccuracies related to the fact that oscillometric NIBP devices under-read high SBP relative to IBP measurements have been recognized as a potential source of maternal morbidity for years. The study will compare IBP readings obtained from morbidly obese, severely hypertensive (SBP > 160 mm Hg) parturients with NIBP consecutively measured with new innovative conical Ultracheck Curve BP cuffs and large standard upper arm rectangular cylindrical BP cuffs.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.