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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04755764
Other study ID # 1681431
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 3, 2021
Est. completion date December 2024

Study information

Verified date March 2024
Source Marshall University
Contact Morgan Ruley, MS
Phone (304) 691-1458
Email kelley115@marshall.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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


Intervention

Drug:
Labetalol
Beta blocker
Atenolol
Beta blocker
Nifedipine
Calcium channel blocker

Locations

Country Name City State
United States Maternal Hypertension Center at Cabell Huntington Hospital Huntington West Virginia

Sponsors (1)

Lead Sponsor Collaborator
Marshall University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic blood pressure Measured in mmHg Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Primary Diastolic blood pressure Measured in mmHg Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Primary Mean arterial pressure Measured in mmHg Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Primary Heart rate Measured in beats per minute Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Primary Cardiac output Measured in liters per minute Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Primary Systemic vascular resistance Measured by dynes ยท sec/cm^-5 Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
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