SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:December 11, 2018
End Date:December 2020
Contact:Ganga Devaiah, MS
Email:ganga_devaiah@trihealth.com
Phone:513-862-2341

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• Adjunctive use of easily-obtainable maternal sonographic vascular measurements assessing
volume status, cardiac output, and systemic vascular resistance by means of inferior vena
cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining
left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x
heart rate), stroke volume variation, & radial artery resistance index) augments standard
vital sign assessment (pulse pressure and systolic / diastolic predominance) in clinical
decision-making potentially leading to more appropriate pharmacologic and clinical therapies
with faster resolution of severe hypertension among pregnant women and women in the
postpartum period.

- Minutes count when it comes to treating and preventing serious complications associated
with hypertensive emergencies in pregnancy. The rates of maternal morbidity and
mortality are on the rise within the United States whereas the rates are falling in the
rest of the developed world. Cardiovascular and neurologic injury associated with the
severe hypertension witnessed among women with preeclampsia/eclampsia represent two of
the leading causes of maternal mortality within the U.S. Optimizing the clinical
identification and response to these perinatal complications represents one means of
reducing overall maternal mortality.

- Point-of-care use of ultrasound technology to augment clinical diagnosis and management
is gaining traction throughout nearly all fields of medicine. Obstetricians utilize this
technology frequently to assess the fetus and maternal-fetal interface, and our ability
to expand its use to assess a deeper understanding of maternal physiology is
underutilized. Exploration into the ability to apply clinically-proven point-of-care
sonographic techniques to augment maternal care and reduce maternal mortality is
warranted.

- The purpose of this study is to gain a deeper understanding of maternal physiologic
changes using easily-obtainable sonographic vascular measurements in the setting of
hypertensive emergencies and to assess the utility of these adjunctive maternal
sonographic measurements in augmenting clinical decision-making.

Inclusion Criteria:

- For symptomatic women, those presenting to triage, admitted to Labor & Delivery or any
of the above units who are at risk for developing a hypertensive emergency will be
identified by the OBGYN resident staff or attending physicians as "at risk" for
hypertensive emergency as based on current chronic hypertension, gestational
hypertension, or preeclampsia). Women presenting with or developing new onset
hypertensive emergency can be offered recruitment as well given that the performance
of these sonographic measures will not interfere with initiating antihypertensive
therapy.

Exclusion Criteria:

- Age < 18 years

- Non-pregnant

- Without the capacity to provide informed written consent

- Non-English speaking without the ability to obtain a hospital interpreter

- Known atrial-ventricular heart block

- History of heart failure

- Moderate-to-Severe bronchial asthma

- Allergy to the medications used as part of regular care treatment of the patient
population

- Lack of intravenous IV access

- Concurrent use of antihypertensive medications

- Congenital heart disease in the mother
We found this trial at
1
site
Cincinnati, Ohio 45220
Phone: 513-862-2341
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Cincinnati, OH
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