Treatment of Severe Hypertension With ICG Directed Therapy

NCT04748107 | Withdrawn

• 1 other identifier: 1605500
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (6)

• The systolic blood pressure

  mmHg

  1 year

• The diastolic blood pressure

  mmHg

  1 year

• mean arterial pressure

  mmHg

  1 year

• heart rate

  beats/minute

  1 year

• cardiac output (L/min)

  liters per minute

  1 year

• systemic vascular resistance

  dynes · sec/cm\^-5

  1 year

Study Arms (2)

Provider preference: Control group

NO INTERVENTION

Provider will prescribe blood pressure medication based on his professional expertise.

ICG directed therapy group

EXPERIMENTAL

ICG directed therapy will be used to determine which blood pressure medication is received.

Diagnostic Test: Impendence Cardiography

Interventions

Impendence Cardiography DIAGNOSTIC_TEST

ICG is a noninvasive method of determining the amount of blood flow using the Non-Invasive Cardiac System - Cardiac Surveyor (NICaS) system, which provides an assessment of the cardiovascular system, respiratory system, and fluid retention.

ICG directed therapy group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressure after 20 weeks gestation. Patients will be English speaking and range in ages from 15-45 years old. Patient's will be consented prior to randomization.

You may not qualify if:

• Patients presenting to Labor and Delivery at Cabell Huntington Hospital with normal range blood pressures, or those with elevated blood pressures who do not consent to the study, patients \<20 weeks gestation, or patients with eclampsia.

Sponsors & Collaborators

• Marshall University: lead

Study Sites (1)

Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

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

• Jesse Cottrell, MD

  Marshall University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomization to treatment of non treatment group

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: February 10, 2021
• Study Start: April 25, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)