NCT03222414

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

Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient (BMI >= 40 kg/m2) With Severe Preeclampsia: A Comparison of Direct Arterial Blood Pressure Measurements With Readings Obtained Using Either Large Cylindrical or Novel Conical Bariatric Upper Arm Blood Pressure Cuffs

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pre-Eclampsia
• Morbid Obesity
• Parturient
• Blood Pressure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-18
• Completion: 2016-01-18
• First posted: 2017-07-19
• Last updated: 2019-12-11
• Results posted: 2019-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study