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

NCT03105661 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: 4226
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Rates of preeclampsia in morbidly obese pregnant women

  Rates of preeclampsia in morbidly obese pregnant women

  2 years

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

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; Drug: NIFEdipine 60 mg; Drug: Atenolol 25 mg

Non-treatment Arm

NO INTERVENTION

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

Interventions

Labetalol Hydrochloride 200 mg DRUG

Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography

Also known as: Trandate

Treatment Arm

NIFEdipine 60 mg DRUG

Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography

Also known as: Procardia

Treatment Arm

Atenolol 25 mg DRUG

Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater

Also known as: Tenormin

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 51 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients 18-51 years old,
• Less than 20 weeks gestation with Morbid Obesity (BMI \>/= 40)
• Not on antihypertensive medications

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Pre-Eclampsia

Interventions

Labetalol; Nifedipine; Atenolol

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Propanols

Study Officials

• Craig V. Towers, MD

  University of Tennessee Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig V. Towers, MD

CONTACT

865-305-8888; ctowers@utmck.edu

Mary Ellen McNeal, BSN, RN

CONTACT

865-305-8888; mmcneal@utmck.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Randomization to treatment or non treatment group

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: April 4, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 4, 2020
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)