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

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients

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.

Study Overview

• Status: Unknown
• Conditions: Obesity, Morbid; Preeclampsia
• Intervention / Treatment: Drug: Labetalol Hydrochloride 200 mg; Drug: NIFEdipine 60 mg; Drug: Atenolol 25 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Craig V. Towers, MD; Phone Number: 865-305-8888; Email: ctowers@utmck.edu
• Study Contact Backup: Name: Mary Ellen McNeal, BSN, RN; Phone Number: 3275 865-305-8888; Email: mmcneal@utmck.edu

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
      • Contact: Craig V. Towers, MD; Phone Number: 865-305-8888; Email: ctowers@utmck.edu
      • Contact: Mary Ellen McNeal, BSN, RN; Phone Number: 3275 865-305-8888; Email: mmcneal@utmck.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Trandate; Drug: NIFEdipine 60 mg; Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography; Other Names: Procardia; Drug: Atenolol 25 mg; Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater; Other Names: Tenormin
No Intervention: Non-treatment Arm; Patients who are randomized to the non-treatment arm will not receive antihypertensive medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of preeclampsia in morbidly obese pregnant women	Rates of preeclampsia in morbidly obese pregnant women	2 years

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine
• Investigators: Principal Investigator: Craig V. Towers, MD, University of Tennessee Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 4, 2020

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Hypertension, Pregnancy-Induced; Obesity; Obesity, Morbid; Pre-Eclampsia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Sympathomimetics; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nifedipine; Labetalol; Atenolol
• Other Study ID Numbers: 4226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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