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

Sponsor
Marshall University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04755764
Collaborator
(none)
60
1
21
2.9

Study Details

Study Description

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.

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography in Early Pregnancy
Actual Study Start Date :
Mar 3, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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:
  • Normodyne
  • Trandate
  • 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:
  • Adalat CC
  • Afeditab CR
  • Nifediac CC
  • Nifedical XL
  • Procardia
  • Procardia XL
  • Outcome Measures

    Primary Outcome Measures

    1. Systolic blood pressure [Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]

      Measured in mmHg

    2. Diastolic blood pressure [Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]

      Measured in mmHg

    3. Mean arterial pressure [Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]

      Measured in mmHg

    4. Heart rate [Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]

      Measured in beats per minute

    5. Cardiac output [Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]

      Measured in liters per minute

    6. Systemic vascular resistance [Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]

      Measured by dynes ยท sec/cm^-5

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maternal Hypertension Center at Cabell Huntington Hospital Huntington West Virginia United States 25701

    Sponsors and Collaborators

    • Marshall University

    Investigators

    • Principal Investigator: Jesse Cottrell, MD, Marshall University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jesse Cottrell, Assistant Professor, Marshall University
    ClinicalTrials.gov Identifier:
    NCT04755764
    Other Study ID Numbers:
    • 1681431
    First Posted:
    Feb 16, 2021
    Last Update Posted:
    May 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2022