Impedance Cardiography to Decrease the Risk of Preeclampsia

NCT03245970 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 4222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.

Conditions

Chronic Hypertension Complicating Pregnancy (Diagnosis); Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Rates of preeclampsia in chronically hypertensive pregnant women

  Rates of preeclampsia in chronically hypertensive pregnant women

  2 years

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

Treatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years. Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily

Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours; Drug: Nifedipine 60 mg orally daily; Drug: Atenolol 25 mg daily

Non Treatment

NO INTERVENTION

Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.

Interventions

Labetalol Hydrocholoride 200 mg orally every 12 hours DRUG

Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography

Also known as: Trandate

Treatment Arm

Nifedipine 60 mg orally daily DRUG

Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography

Also known as: Procardia

Treatment Arm

Atenolol 25 mg daily 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 mild chronic hypertension - 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 Medical Center: lead

Study Sites (1)

HIgh Risk Obstetrical Consultants

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Disease; Pre-Eclampsia

Interventions

Labetalol; Nifedipine; Atenolol

Condition Hierarchy (Ancestors)

Pathologic Processes; 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

• Kimberly Fortner, MD

  University of Tennessee Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to treatment or non treatment group

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 10, 2017
• Study Start: April 24, 2017
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)