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

Recruiting

• Conditions: Diastolic Hypertension; Cardiac Output, High; Cardiac Output, Low; Pregnancy Related; Systolic Hypertension
• Interventions: Drug: Nifedipine; Drug: Labetalol; Drug: Atenolol

• Registration Number: NCT04755764
• Lead Sponsor: Marshall University

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 Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-16
• Study Start: 2021-03-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nifedipine	Nifedipine	Nifedipine will be given for a mean arterial pressure \>100.
Beta blockade	Atenolol	Beta blocker (labetalol or atenolol) will be given for a cardiac output \>8 l/min.
Beta blockade	Labetalol	Beta blocker (labetalol or atenolol) will be given for a cardiac output \>8 l/min.

Primary Outcome Measures

Name	Time	Method
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
Systemic vascular resistance	Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.	Measured by dynes · sec/cm\^-5
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
Systolic blood pressure	Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.	Measured in mmHg
Diastolic blood pressure	Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.	Measured in mmHg
Mean arterial pressure	Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.	Measured in mmHg

Trial Locations

Locations (1)

Maternal Hypertension Center at Cabell Huntington Hospital; 🇺🇸 Huntington, West Virginia, United States