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Impedance Cardiography to Decrease the Risk of Preeclampsia

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03245970
Enrollment
0
Registered
2017-08-10
Start date
2017-04-24
Completion date
2020-02-29
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hypertension Complicating Pregnancy (Diagnosis), Preeclampsia

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.

Interventions

DRUGLabetalol Hydrocholoride 200 mg orally every 12 hours

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

DRUGNifedipine 60 mg orally daily

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

DRUGAtenolol 25 mg daily

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

Sponsors

University of Tennessee Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomization to treatment or non treatment group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
Rates of preeclampsia in chronically hypertensive pregnant women2 yearsRates of preeclampsia in chronically hypertensive pregnant women

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026