Impedance Cardiography to Decrease the Risk of Preeclampsia

NCT ID: NCT03245970

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2020-02-29

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.

Conditions

Chronic Hypertension Complicating Pregnancy (Diagnosis); Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Labetalol Hydrocholoride 200 mg orally every 12 hours

Intervention Type: DRUG

Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography

Nifedipine 60 mg orally daily

Intervention Type: DRUG

Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography

Atenolol 25 mg daily

Intervention Type: DRUG

Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater

Non Treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Labetalol Hydrocholoride 200 mg orally every 12 hours

Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography

Intervention Type: DRUG

Nifedipine 60 mg orally daily

Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography

Intervention Type: DRUG

Atenolol 25 mg daily

Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater

Intervention Type: DRUG

Other Intervention Names

Trandate; Procardia; Tenormin

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Fortner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Medical Center

Locations

HIgh Risk Obstetrical Consultants

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

4222

Identifier Type: -

Identifier Source: org_study_id