Not provided
Not provided
Not provided
Not provided
Not provided
Changes in standard of care have altered the feasibility of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Conical then Cylindrical | Experimental | 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 |
|
| Arm B: Cylindrical then Conical | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive BP recording with conical Ultracheck Curve BP cuff | Device | Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement | Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings | Single time point measurement (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring | Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings | Single time point measurement (1 day) |
| Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Sorabella, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32748394 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
3 participants were randomized, but data was not analyzable on 2 participants. Randomization assignment was not recorded on these 2 participants.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-invasive BP recording with traditional cylindrical BP cuff | Device | Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff |
|
| Direct invasive arterial pressure | Other | Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements |
|
Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings |
| Single time point measurement (1 day) |
| Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs | mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs | Single time point measurement (1 day) |
| Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs | Mean of 2 MAP readings taken with cylindrical and conical BP cuffs | Single time point measurement (1 day) |
| Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs | Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs | Single time point measurement (1 day) |
| FG001 | 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 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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements |
| COMPLETED |
|
| NOT COMPLETED |
|
3 participants were randomized, but data was collected incorrectly on 2 participants, so data was unusable on those 2 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements |
| BG001 | 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 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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement | Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings | Posted | Number | mm Hg | Single time point measurement (1 day) |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring | Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings | Posted | Number | mm Hg | Single time point measurement (1 day) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement | Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings | Posted | Number | mm Hg | Single time point measurement (1 day) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs | mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs | Posted | Mean | Standard Deviation | mm Hg | Single time point measurement (1 day) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs | Mean of 2 MAP readings taken with cylindrical and conical BP cuffs | Posted | Mean | Standard Deviation | mm Hg | Single time point measurement (1 day) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs | Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs | Posted | Mean | Standard Deviation | mm Hg | Single time point measurement (1 day) |
|
|
1 hour
there were 0 in that arm
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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 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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Sorabella | Vanderbilt University Medical Center | laura.sorabella@vumc.org |
| Nov 13, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|
|
|
|