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Impedance Cardiography to Decrease the Risk of Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245970
Recruitment Status : Withdrawn (Investigator retired. Other investigators did not want to continue study.)
First Posted : August 10, 2017
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Tennessee Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hypertension Complicating Pregnancy (Diagnosis) Preeclampsia Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours Drug: Nifedipine 60 mg orally daily Drug: Atenolol 25 mg daily Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to treatment or non treatment group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Impedance Cardiography to Decrease the Risk of Preeclampsia
Actual Study Start Date : April 24, 2017
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


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 Name: Trandate

Drug: Nifedipine 60 mg orally daily
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
Other Name: Procardia

Drug: Atenolol 25 mg daily
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
Other Name: Tenormin

No Intervention: Non Treatment
Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.



Primary Outcome Measures :
  1. Rates of preeclampsia in chronically hypertensive pregnant women [ Time Frame: 2 years ]
    Rates of preeclampsia in chronically hypertensive pregnant women



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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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 -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245970


Locations
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United States, Tennessee
HIgh Risk Obstetrical Consultants
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University of Tennessee Medical Center
Investigators
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Principal Investigator: Kimberly Fortner, MD University of Tennessee Medical Center
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Responsible Party: University of Tennessee Medical Center
ClinicalTrials.gov Identifier: NCT03245970    
Other Study ID Numbers: 4222
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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