Impedance Cardiography to Decrease the Risk of Preeclampsia
- Conditions
- Chronic Hypertension Complicating Pregnancy (Diagnosis)Preeclampsia
- Interventions
- Registration Number
- NCT03245970
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications
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 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm Nifedipine 60 mg orally daily 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 Treatment Arm Atenolol 25 mg daily 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 Treatment Arm Labetalol Hydrocholoride 200 mg orally every 12 hours 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
- Primary Outcome Measures
Name Time Method Rates of preeclampsia in chronically hypertensive pregnant women 2 years Rates of preeclampsia in chronically hypertensive pregnant women
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
HIgh Risk Obstetrical Consultants
🇺🇸Knoxville, Tennessee, United States
HIgh Risk Obstetrical Consultants🇺🇸Knoxville, Tennessee, United States