Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy

May 9, 2025 updated by: Jesse Cottrell, Marshall University

The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography in Early Pregnancy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

When a patient presents to the Maternal Hypertension Center at Cabell Huntington Hospital, she will receive a non-invasive hemodynamic assessment via the NICaS system as per usual protocol. The NICaS system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. In typical practice, the vasodilator nifedipine is initiated for increased systemic vascular resistance and elevated cardiac output is treated with beta blockade (via either atenolol or labetalol). The medication to be given to each subject will be based on their hemodynamics. Specifically, nifedipine will be given for a mean arterial pressure >100 and a beta blocker will be given for a cardiac output >8 l/min. The patients will be asked to return in one week for repeat ICG measurement.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Maternal Hypertension Center at Cabell Huntington Hospital
        • Contact:
        • Principal Investigator:
          • Jesse Cottrell, MD
        • Sub-Investigator:
          • David Chaffin, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the Maternal Hypertension Center at Cabell Huntington Hospital. Consent will be obtained prior to enrollment. Patient age range will be from age 18 to approximately 45.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Beta blockade
Beta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min.
Drug: Labetalol
Beta blocker
Other Names:
  • Trandate
  • Normodyne
Drug: Atenolol
Beta blocker
Other Names:
  • Tenormin
Nifedipine
Nifedipine will be given for a mean arterial pressure >100.
Drug: Nifedipine
Calcium channel blocker
Other Names:
  • Procardia
  • Procardia XL
  • Adalat CC
  • Afeditab CR
  • Nifediac CC
  • Nifedical XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Measured in mmHg
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.
Measured in mmHg
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.
Measured in mmHg
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.
Measured in beats per minute
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.
Measured in liters per minute
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.
Measured by dynes · sec/cm^-5
Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marshall University

Investigators

  • Principal Investigator: Jesse Cottrell, MD, Marshall University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1681431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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