Recruiting
Early Phase 1

Impedance Cardiography

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT03105661

Conditions

Obesity, Morbid

Preeclampsia

Eligibility Criteria

Sex: Female

Age: 18 - 51

Healthy Volunteers: Not accepted

Interventions

Labetalol Hydrochloride 200 mg

NIFEdipine 60 mg

Atenolol 25 mg

Study Details

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

Study ID

NCT03105661

Start date

Apr 4, 2017

Status verified date

Feb, 2019

Completion date

Mar 4, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 51

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

no intervention: Non-treatment Arm

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

Interventions

Labetalol Hydrochloride 200 mg

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

NIFEdipine 60 mg

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

Atenolol 25 mg

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

Primary outcome measure

  • Rates of preeclampsia in morbidly obese pregnant women [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Craig V. Towers, MD

865-305-8888ctowers@utmck.edu

Mary Ellen McNeal, BSN, RN

865-305-8888mmcneal@utmck.edu

Locations

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Craig V. Towers, MD

865-305-8888ctowers@utmck.edu

Mary Ellen McNeal, BSN, RN

865-305-8888mmcneal@utmck.edu

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Feb 22, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2019-02-22.