Pre-EclampsiaNCT03222414

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

A study testing Non-invasive BP recording with conical Ultracheck Curve BP cuff, Non-invasive BP recording with traditional cylindrical BP cuff and Direct invasive arterial pressure in people with Pre-Eclampsia and Morbid Obesity, run by Vanderbilt University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pre-Eclampsia, Morbid Obesity, Parturient
What is being tested?: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Non-invasive BP recording with traditional cylindrical BP cuff and Direct invasive arterial pressure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 1 May 2015to 18 Jan 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Parturients admitted in labor

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

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

Read the 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
Being tested: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Non-invasive BP recording with traditional cylindrical BP cuff, Direct invasive arterial pressure
Medical subject headings: Pre-Eclampsia, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-invasive BP recording with conical Ultracheck Curve BP cuffDevice
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 cuffDevice
Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff
Direct invasive arterial pressureOther
Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements

Study groups in NCT03222414
Study group	Role	What they receive
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 Receives: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Device: Non-invasive BP recording with traditional cylindrical BP cuff; Other: Direct invasive arterial pressure
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 Receives: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Device: Non-invasive BP recording with traditional cylindrical BP cuff; Other: Direct invasive arterial pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Single time point measurement (1 day)

Secondary outcomes (5)

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
Measured: Single time point measurement (1 day)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Single time point measurement (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201518 Jan 2016

First posted19 Jul 2017
Study start1 May 2015
Primary completion18 Jan 2016
Study completion18 Jan 2016

Why it stopped: Changes in standard of care have altered the feasibility of the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03222414
Sponsor's protocol ID: 150606
Status last verified: Dec 2019
First submitted: 17 Jul 2017
Last updated: 11 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 32748394

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia

All Pre-Eclampsia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03222414
Acronym / sponsor ID: 150606
Conditions: Pre-Eclampsia, Morbid Obesity, Parturient, Blood Pressure
Study type: Interventional
Recruitment status: TerminatedReason stopped: Changes in standard of care have altered the feasibility of the study.
Enrolment: 3 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 1 May 2015 (actual)
Primary completion: 18 Jan 2016 (actual)
Study completion: 18 Jan 2016 (actual)
First posted: 19 Jul 2017 (actual)
Results: Posted 11 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Conical then Cylindrical	Experimental	Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressureBP 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	Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressureBP 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Parturients admitted in labor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-invasive BP recording with conical Ultracheck Curve BP cuffNon-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff	Device	Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical
Non-invasive BP recording with traditional cylindrical BP cuffNon-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff	Device	Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical
Direct invasive arterial pressureDirect invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements	Other	Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical

Primary outcome

Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Time frame: Single time point measurement (1 day)
Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings

5 secondary outcomes

Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring
Time frame: Single time point measurement (1 day)
Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Time frame: Single time point measurement (1 day)
Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs
Time frame: Single time point measurement (1 day)
Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
Time frame: Single time point measurement (1 day)
Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs
Time frame: Single time point measurement (1 day)

Results and safety

Results posted to the registry on 11 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Conical Then Cylindrical	0	0
Arm B: Cylindrical Then Conical	1	1

Primary outcome: Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement

Time frame: Single time point measurement (1 day). Number. Unit: mm Hg

Measure	Conical n = 1	Cylindrical n = 1
Value	-28	-6.5

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Conical Then Cylindrical	0 of 0	0 of 0	0
Arm B: Cylindrical Then Conical	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32748394Ashworth 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.
Individual participant dataSharing planned: No

Related trials for Pre-Eclampsia

Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Sorabella, M.D. principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement (time frame: Single time point measurement (1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03222414, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.