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Impedance Cardiography to Decrease the Risk of Preeclampsia

Primary Purpose

Chronic Hypertension Complicating Pregnancy (Diagnosis), Preeclampsia

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Labetalol Hydrocholoride 200 mg orally every 12 hours
Nifedipine 60 mg orally daily
Atenolol 25 mg daily
Sponsored by
University of Tennessee Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Hypertension Complicating Pregnancy (Diagnosis)

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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 -

Sites / Locations

  • HIgh Risk Obstetrical Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment Arm

Non Treatment

Arm Description

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

Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.

Outcomes

Primary Outcome Measures

Rates of preeclampsia in chronically hypertensive pregnant women
Rates of preeclampsia in chronically hypertensive pregnant women

Secondary Outcome Measures

Full Information

First Posted
August 8, 2017
Last Updated
August 3, 2020
Sponsor
University of Tennessee Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03245970
Brief Title
Impedance Cardiography to Decrease the Risk of Preeclampsia
Official Title
Use of Impedance Cardiography to Decrease the Risk of Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator retired. Other investigators did not want to continue study.
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hypertension Complicating Pregnancy (Diagnosis), Preeclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomization to treatment or non treatment group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Non Treatment
Arm Type
No Intervention
Arm Description
Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.
Intervention Type
Drug
Intervention Name(s)
Labetalol Hydrocholoride 200 mg orally every 12 hours
Other Intervention Name(s)
Trandate
Intervention Description
Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
Intervention Type
Drug
Intervention Name(s)
Nifedipine 60 mg orally daily
Other Intervention Name(s)
Procardia
Intervention Description
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
Intervention Type
Drug
Intervention Name(s)
Atenolol 25 mg daily
Other Intervention Name(s)
Tenormin
Intervention Description
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
Primary Outcome Measure Information:
Title
Rates of preeclampsia in chronically hypertensive pregnant women
Description
Rates of preeclampsia in chronically hypertensive pregnant women
Time Frame
2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Fortner, MD
Organizational Affiliation
University of Tennessee Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIgh Risk Obstetrical Consultants
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impedance Cardiography to Decrease the Risk of Preeclampsia

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