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Impedance Cardiography to Decrease the Risk of Preeclampsia

NCT03245970 — Early Phase 1, Withdrawn, University of Tennessee Medical Center

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Use of Impedance Cardiography to Decrease the Risk of Preeclampsia

RegistryNCT03245970
StatusWithdrawn - Investigator retired. Other investigators did not want to continue study.
PhaseEarly Phase 1
Study typeInterventional; randomized, parallel, masking: none, prevention
SponsorUniversity of Tennessee Medical Center (Other)
ConditionsChronic Hypertension Complicating Pregnancy (Diagnosis), Preeclampsia
InterventionsLabetalol Hydrocholoride 200 mg orally every 12 hours, Nifedipine 60 mg orally daily, Atenolol 25 mg daily (Drug)
Datesstart 2017-04-24, primary completion 2020-02-29, completion 2020-02-29, first posted 2017-08-10, last updated 2020-08-05
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Treatment ArmActive comparatorDrug: Labetalol Hydrocholoride 200 mg orally every 12 hours; Drug: Nifedipine 60 mg orally daily; Drug: Atenolol 25 mg dailyTreatment 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 TreatmentNo interventionNon treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.
  • Labetalol Hydrocholoride 200 mg orally every 12 hours (Drug), also known as Trandate: Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
  • Nifedipine 60 mg orally daily (Drug), also known as Procardia: Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
  • Atenolol 25 mg daily (Drug), also known as Tenormin: Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater

+Outcome measures

Primary outcomes

  • Rates of preeclampsia in chronically hypertensive pregnant women [2 years]: Rates of preeclampsia in chronically hypertensive pregnant women

+Eligibility

Sex: Female, ages: 18 Years to 51 Years

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 -

+Locations (1)

FacilityCityCountryStatus
HIgh Risk Obstetrical ConsultantsKnoxville, TennesseeUnited States

+Investigators

My Notes