NCT03245970

Impedance Cardiography to Decrease the Risk of Preeclampsia

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Tennessee Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Hypertension Complicating Pregnancy (Diagnosis)
• Preeclampsia

Interventions

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

Timeline

• Start date: 2017-04-24
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2017-08-10
• Last updated: 2020-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study