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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04755764
• Other study ID #: 1681431
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Output, High
• Cardiac Output, Low
• Diastolic Hypertension
• Hypertension
• Isolated Systolic Hypertension
• Pregnancy Related
• Systolic Hypertension

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 · sec/cm^-5	Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.