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Trial record 65 of 116 for:    Atenolol

Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients

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ClinicalTrials.gov Identifier: NCT03105661
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Ellen McNeal, University of Tennessee Graduate School of Medicine

Brief Summary:
To determine if the use of impedance cardiography can identify appropriate medications for use in treating morbidly obese patients to decrease the risk of preeclampsia.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Preeclampsia Drug: Labetalol Hydrochloride 200 mg Drug: NIFEdipine 60 mg Drug: Atenolol 25 mg Early Phase 1

Detailed Description:

Research Protocol

Use of Impedance Cardiography to decrease the risk of preeclampsia in obese patients

Background: Obesity is epidemic in the United States and this is leading to an increase in the number of pregnant patients with obesity. Obesity, especially morbid obesity (BMI >/= 40), increases the risk of developing preeclampsia when compared to the non-obese population. Impedance Cardiography has never been used to evaluate this patient population to see if they have abnormal cardiac output and/or abnormal peripheral resistance. If identified, low dose medical treatment can be done to normalize these patterns early on to see if this treatment modality decreases the development of preeclampsia and other pregnancy complications.

Specific Aims: The primary aim of this study is to determine if the use of Impedance Cardiography can help identify the appropriate medicine for use in treating morbidly obese patients that have abnormal testing results, to see if by normalizing impedance cardiography testing parameters results in a decrease in the incidence of preeclampsia in general and other pregnancy complications.

Enrollment: All pregnant patients, 18-51 years old, less than 20 weeks pregnant, with a BMI >/= 40 will undergo impedance cardiography and if the results are abnormal, will be provided informed consent to participate. If consent is given, and blood pressure is < 140/90,they will be eligible for enrollment.

Randomization: All patients who meet criteria will undergo impedance cardiography. Those with abnormal results will be randomized as the whether they will be treated or not. Randomization will require they blindly pull a paper labelled "yes" or "no" from a container. Those who select "yes" will be randomized to the treatment arm and will be prescribed antihypertensive medications commonly used in obstetrics for hypertension (labetalol, nifedipine, atenolol) Those who select "no" will not receive medication.

Study Procedure: All pregnant patients that meet study criteria and have abnormal Impedance Cardiography testing will be asked to participate, consented and randomized to the treatment or non treatment arm. The treatment group will receive antihypertensive medications as listed above and undergo monthly cardiography testing after beginning treatment with medication adjustments until normal test results are obtained. The non treatment group will undergo repeat cardiography testing 8 weeks after the first test to compare results. All enrolled patients will be followed with regular prenatal care for their prospective conditions and followed closely for the development of high or low blood pressure and preeclampsia.

Adverse events: Adverse events related to this study are minimal because the test is non invasive and complications for Impedance Cardiology are non existent. In addition, the drugs used to treat hypertension have been used in obstetrics for over 30 years with good results and minimal problems.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to treatment or non treatment group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 4, 2020


Arm Intervention/treatment
Active Comparator: Treatment Arm

Patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.

Labetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily

Drug: Labetalol Hydrochloride 200 mg
Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography
Other Name: Trandate

Drug: NIFEdipine 60 mg
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography
Other Name: Procardia

Drug: Atenolol 25 mg
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
Other Name: Tenormin

No Intervention: Non-treatment Arm
Patients who are randomized to the non-treatment arm will not receive antihypertensive medications.



Primary Outcome Measures :
  1. Rates of preeclampsia in morbidly obese pregnant women [ Time Frame: 2 years ]
    Rates of preeclampsia in morbidly obese pregnant women



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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant patients 18-51 years old,
  • Less than 20 weeks gestation with Morbid Obesity (BMI >/= 40)
  • 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

Information from the National Library of Medicine

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): NCT03105661


Contacts
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Contact: Craig V. Towers, MD 865-305-8888 ctowers@utmck.edu
Contact: Mary Ellen McNeal, BSN, RN 865-305-8888 ext 3275 mmcneal@utmck.edu

Locations
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United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Craig V. Towers, MD    865-305-8888    ctowers@utmck.edu   
Contact: Mary Ellen McNeal, BSN, RN    865-305-8888 ext 3275    mmcneal@utmck.edu   
Sponsors and Collaborators
University of Tennessee Graduate School of Medicine
Investigators
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Principal Investigator: Craig V. Towers, MD University of Tennessee Graduate School of Medicine

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Responsible Party: Mary Ellen McNeal, Research Coordinator, University of Tennessee Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT03105661     History of Changes
Other Study ID Numbers: 4226
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atenolol
Pre-Eclampsia
Obesity, Morbid
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Labetalol
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents