Impedance Cardiography to Decrease the Risk of Preeclampsia
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|ClinicalTrials.gov Identifier: NCT03245970|
Recruitment Status : Withdrawn (Investigator retired. Other investigators did not want to continue study.)
First Posted : August 10, 2017
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hypertension Complicating Pregnancy (Diagnosis) Preeclampsia||Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours Drug: Nifedipine 60 mg orally daily Drug: Atenolol 25 mg daily||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization to treatment or non treatment group|
|Masking:||None (Open Label)|
|Official Title:||Use of Impedance Cardiography to Decrease the Risk of Preeclampsia|
|Actual Study Start Date :||April 24, 2017|
|Actual Primary Completion Date :||February 29, 2020|
|Actual Study Completion Date :||February 29, 2020|
Active Comparator: 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
Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours
Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
Other Name: Trandate
Drug: Nifedipine 60 mg orally daily
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
Other Name: Procardia
Drug: Atenolol 25 mg daily
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
Other Name: Tenormin
No Intervention: Non Treatment
Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.
- Rates of preeclampsia in chronically hypertensive pregnant women [ Time Frame: 2 years ]Rates of preeclampsia in chronically hypertensive pregnant women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245970
|United States, Tennessee|
|HIgh Risk Obstetrical Consultants|
|Knoxville, Tennessee, United States, 37920|
|Principal Investigator:||Kimberly Fortner, MD||University of Tennessee Medical Center|