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Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
110 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for pregnant women to test a new way to measure blood pressure. Participants will be those who are receiving care in a Labor and Delivery setting.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman 18 years or older
I have a body mass index (BMI) of 20 or greater
I am in spontaneous labor or being induced for labor
I may have gestational hypertension or preeclampsia
You may not be able to join if
I have significant peripheral arterial disease with a large blood pressure difference between my arms
I have a history of congenital heart disease
I have a history of significant arrhythmia
I have a pacemaker or an implantable cardioverter defibrillator
I have a history of sickle cell disease
I have Raynaud's phenomenon
I have had lymph node dissection in either arm
I am under 18 years of age
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypert…
The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods.
STUDY ENDPOINTS:
Primary Outcome Measures:
* Agreement between conical and cylindrical cuff systolic blood pressure across groups
* Agreement between conical and cylindrical cuff diastolic blood pressure across groups
Secondary Outcome Measures:
• Agreement between conical and cylindrical cuff mean arterial pressure
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women who are 18 years of age or older with a
* Body mass index (BMI) of 20 kg/m2 or greater
* Present to Labor and Delivery with or without a diagnosis of gestational hypertension, preeclampsia, or chronic hypertension with super-imposed preeclampsia, in spontaneous labor or …
Inclusion Criteria:
* Women who are 18 years of age or older with a
* Body mass index (BMI) of 20 kg/m2 or greater
* Present to Labor and Delivery with or without a diagnosis of gestational hypertension, preeclampsia, or chronic hypertension with super-imposed preeclampsia, in spontaneous labor or for induction of labor
Exclusion Criteria:
* Significant peripheral arterial disease resulting in at least a 10 mm Hg blood pressure difference between both arms
* History of repaired or unrepaired congenital heart disease
* History of significant arrythmia
* History of pacemaker or implantable cardioverter defibrillator placement
* History of sickle cell disease
* History of Raynaud's phenomenon on any extremity
* History of lymph node dissection of either upper extremity
* Patients who are less than 18 years of age
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