Impedance Cardiography to Decrease the Risk of Preeclampsia

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia

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.

Study Overview

• Status: Withdrawn
• Conditions: Preeclampsia; Chronic Hypertension Complicating Pregnancy (Diagnosis)
• Intervention / Treatment: Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours; Drug: Nifedipine 60 mg orally daily; Drug: Atenolol 25 mg daily

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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • High Risk Obstetrical Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment Arm; Treatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years. Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily	Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours; Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography; Other Names: Trandate; Drug: Nifedipine 60 mg orally daily; Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography; Other Names: Procardia; Drug: Atenolol 25 mg daily; Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater; Other Names: Tenormin
NO_INTERVENTION: Non Treatment; Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of preeclampsia in chronically hypertensive pregnant women	Rates of preeclampsia in chronically hypertensive pregnant women	2 years

Collaborators and Investigators

• Sponsor: University of Tennessee Medical Center
• Investigators: Principal Investigator: Kimberly Fortner, MD, University of Tennessee Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2017
• Primary Completion (ACTUAL): February 29, 2020
• Study Completion (ACTUAL): February 29, 2020

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (ACTUAL): August 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypertension, Pregnancy-Induced; Pre-Eclampsia; Pregnancy Complications; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Sympathomimetics; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nifedipine; Labetalol; Atenolol
• Other Study ID Numbers: 4222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes