SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy

Status unconfirmed

Conditions studied: Hypertension in Pregnancy

In brief

• 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.

Key facts

Study ID

NCT03783169

Run by

TriHealth Inc.

People needed

120

Starts

2018-12-11

Expected to finish

2020-12-01

Last updated by the study team

2020-01-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• TriHealth - Good Samaritan and Bethesda North Hospitals — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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