Recruiting

Labetalol, Atenolol, Nifedipine

Sponsor:

Marshall University

Code:

NCT04755764

Conditions

Systolic Hypertension

Pregnancy Related

Diastolic Hypertension

Cardiac Output, Low

Cardiac Output, High

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Labetalol

Atenolol

Nifedipine

Study Details

Brief summary:

The purpose of the research is to characterize the effect of labetalol, atenolol, and nifedipine on maternal hemodynamics early in pregnancy. Patients will be given medication based on their hemodynamics and asked to return for a repeat measurement.

Conditions

Systolic Hypertension

Pregnancy Related

Diastolic Hypertension

Cardiac Output, Low

Cardiac Output, High

Study ID

NCT04755764

Start date

Mar 3, 2021

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients presenting to Maternal Hypertension Center at Cabell Huntington Hospital
  • English speaking
  • 18-45 years old.
  • Willing to provide informed consent
  • Gestational age prior to 15 weeks gestation

Exclusion Criteria:

  • Non-English speaking patients, patients
  • <18 years old or >45 years old
  • Not willing or able to provide consent
  • Gestational age >15 weeks

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Beta blockade

Beta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min.

Nifedipine

Nifedipine will be given for a mean arterial pressure >100.

Interventions

Labetalol

Beta blocker

Atenolol

Beta blocker

Nifedipine

Calcium channel blocker

Primary outcome measure

  • Systolic blood pressure [ Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. ]
  • Diastolic blood pressure [ Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. ]
  • Mean arterial pressure [ Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. ]
  • Heart rate [ Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. ]
  • Cardiac output [ Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. ]
  • Systemic vascular resistance [ Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. ]

Central Contacts and Locations

Central contacts

Morgan Ruley, MS

(304) 691-1458kelley115@marshall.edu

Jesse Cottrell, MD

(304) 691-1400cottrellje@marshall.edu

Locations

Maternal Hypertension Center at Cabell Huntington Hospital

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Jesse Cottrell, MD

3046911400cottrellje@marshall.edu

Morgan Ruley, MS

3046911458kelley115@marshall.edu

Principal Investigator:

Jesse Cottrell, MD

More Information

Sponsor

Marshall University

Last update posted

May 13, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marshall University on 2025-05-13.