Recruiting

Observational Study

Sponsor:

TriHealth Inc.

Code:

NCT03783169

Conditions

Hypertension in Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cardiovascular Sonographic Assessment

Study Details

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

Study ID

NCT03783169

Start date

Dec 11, 2018

Status verified date

Jan, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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)

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: At Enrollment into the Study ]

Central Contacts and Locations

Central contacts

Ganga Devaiah, MS

513-862-2341ganga_devaiah@trihealth.com

Amy Knapp-Jones, MSN, RN

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

Locations

TriHealth - Good Samaritan and Bethesda North Hospitals

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Ganga Devaiah, MS

513-862-2341ganga_devaiah@trihealth.com

More Information

Sponsor

TriHealth Inc.

Last update posted

Jan 9, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2020-01-09.