SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy

NCT03783169 | Unknown

• 1 other identifier: 18-027
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Systolic Blood Pressure at Enrollment into the Study

  At Enrollment into the Study

Study Arms (2)

Symptomatic patients

All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure \> 160 mmHg or sustained diastolic blood pressure \> 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).

Other: Cardiovascular Sonographic Assessment

Asymptomatic patients

All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).

Other: Cardiovascular Sonographic Assessment

Interventions

Cardiovascular Sonographic Assessment OTHER

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)

Asymptomatic patients; Symptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Group 1: All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure \> 160 mmHg or sustained diastolic blood pressure \> 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves). * Group 2: All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).

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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth - Good Samaritan and Bethesda North Hospitals

Cincinnati, Ohio, 45220, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• William Schnettler, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ganga Devaiah, MS

CONTACT

513-862-2341; ganga_devaiah@trihealth.com

Amy Knapp-Jones, MSN, RN

CONTACT

513-865-1148; amy_knapp-jones@trihealth.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: December 11, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)