Impedance Cardiography to Decrease the Risk of Preeclampsia

Preeclampsia Clinical Trial

Official title:

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03245970
• Other study ID #: 4222
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: April 24, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: August 2020
• Source: University of Tennessee Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.

Description:

Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. The test is easy to perform and non invasive. The treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse.

All centers in the United States that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. Many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. The current recommendation for pregnancy is to NOT treat mild hypertension because studies have not shown any benefit. These studies, have also not shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

Inclusion Criteria:

Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications

Exclusion Criteria:

Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood pressure 140/90 or greater -

Related Conditions & MeSH terms

• Chronic Hypertension Complicating Pregnancy (Diagnosis)
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

Intervention

Drug:
• Labetalol Hydrocholoride 200 mg orally every 12 hours
Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
• Nifedipine 60 mg orally daily
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
• Atenolol 25 mg daily
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater

Locations

Country	Name	City	State
United States	HIgh Risk Obstetrical Consultants	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of preeclampsia in chronically hypertensive pregnant women	Rates of preeclampsia in chronically hypertensive pregnant women	2 years