SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy

Hypertension in Pregnancy Clinical Trial

— SASH  

Official title:

SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03783169
• Other study ID #: 18-027
• Status: Recruiting
• Start date: December 11, 2018
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: TriHealth Inc.
• Contact: Ganga Devaiah, MS
• Phone: 513-862-2341
• Email: ganga_devaiah[@]trihealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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.

Description:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

Other:
• Cardiovascular Sonographic Assessment
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)

Locations

Country	Name	City	State
United States	TriHealth - Good Samaritan and Bethesda North Hospitals	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Systolic Blood Pressure at Enrollment into the Study	At Enrollment into the Study