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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04755764
Enrollment
60
Registered
2021-02-16
Start date
2021-03-03
Completion date
2025-12-31
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGLabetalol

Beta blocker

DRUGAtenolol

Beta blocker

DRUGNifedipine

Calcium channel blocker

Sponsors

Marshall University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressureInitial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.Measured in mmHg
Diastolic blood pressureInitial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.Measured in mmHg
Mean arterial pressureInitial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.Measured in mmHg
Heart rateInitial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.Measured in beats per minute
Cardiac outputInitial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.Measured in liters per minute
Systemic vascular resistanceInitial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.Measured by dynes · sec/cm\^-5

Countries

United States

Contacts

Primary ContactMorgan Ruley, MS
kelley115@marshall.edu(304) 691-1458
Backup ContactJesse Cottrell, MD
cottrellje@marshall.edu(304) 691-1400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026