Clinical trial NCT03222414: Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Eclampsia
Morbid Obesity
Parturient
Blood Pressure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement
timeFrame: Single time point measurement (1 day)
Secondary outcomes:
measure: Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring
timeFrame: Single time point measurement (1 day)
measure: Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement
timeFrame: Single time point measurement (1 day)
measure: Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs
timeFrame: Single time point measurement (1 day)
measure: Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
timeFrame: Single time point measurement (1 day)
measure: Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs
timeFrame: Single time point measurement (1 day)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Laura Sorabella, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.