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

Primary Purpose

Obesity, Morbid, Preeclampsia

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Labetalol Hydrochloride 200 mg
NIFEdipine 60 mg
Atenolol 25 mg
Sponsored by
University of Tennessee Graduate School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Morbid

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Tennessee Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment Arm

Non-treatment Arm

Arm Description

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

Patients who are randomized to the non-treatment arm will not receive antihypertensive medications.

Outcomes

Primary Outcome Measures

Rates of preeclampsia in morbidly obese pregnant women
Rates of preeclampsia in morbidly obese pregnant women

Secondary Outcome Measures

Full Information

First Posted
April 4, 2017
Last Updated
February 20, 2019
Sponsor
University of Tennessee Graduate School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03105661
Brief Title
Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients
Official Title
Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 4, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee Graduate School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Preeclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomization to treatment or non treatment group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Non-treatment Arm
Arm Type
No Intervention
Arm Description
Patients who are randomized to the non-treatment arm will not receive antihypertensive medications.
Intervention Type
Drug
Intervention Name(s)
Labetalol Hydrochloride 200 mg
Other Intervention Name(s)
Trandate
Intervention Description
Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography
Intervention Type
Drug
Intervention Name(s)
NIFEdipine 60 mg
Other Intervention Name(s)
Procardia
Intervention Description
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography
Intervention Type
Drug
Intervention Name(s)
Atenolol 25 mg
Other Intervention Name(s)
Tenormin
Intervention Description
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
Primary Outcome Measure Information:
Title
Rates of preeclampsia in morbidly obese pregnant women
Description
Rates of preeclampsia in morbidly obese pregnant women
Time Frame
2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig V. Towers, MD
Phone
865-305-8888
Email
ctowers@utmck.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Ellen McNeal, BSN, RN
Phone
865-305-8888
Ext
3275
Email
mmcneal@utmck.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig V. Towers, MD
Organizational Affiliation
University of Tennessee Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig V. Towers, MD
Phone
865-305-8888
Email
ctowers@utmck.edu
First Name & Middle Initial & Last Name & Degree
Mary Ellen McNeal, BSN, RN
Phone
865-305-8888
Ext
3275
Email
mmcneal@utmck.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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