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NCT Number: NCT04755764

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Maternal Hypertension Center at Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location status: Recruiting

Location contact

David Chaffin, MD

SUB_INVESTIGATOR

Jesse Cottrell, MD

CONTACT

[email protected]

3046911400

Jesse Cottrell, MD

PRINCIPAL_INVESTIGATOR

Morgan Ruley, MS

CONTACT

[email protected]

3046911458

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

labetalol

Drug

Beta blocker

Other names: Normodyne, Trandate

Atenolol

Drug

Beta blocker

Other names: Tenormin

nifedipine

Drug

Calcium channel blocker

Other names: Adalat CC, Afeditab CR, Nifediac CC, Nifedical XL, Procardia, Procardia XL

Primary outcomes

  1. Systolic blood pressure

    Time frame: 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

    Time frame: 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

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

    Measured in mmHg

  4. Heart rate

    Time frame: 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

    Time frame: 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

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

    Measured by dynes · sec/cm^-5

Study contacts

Contact information is provided by the study sponsor or research team.

Jesse Cottrell, MD

CONTACT

[email protected]

(304) 691-1400

Morgan Ruley, MS

CONTACT

[email protected]

(304) 691-1458

Sponsors and collaborators

Lead sponsor

Marshall University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2021
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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