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

M

Marshall University

Status

Enrolling

Conditions

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

Treatments

Drug: Nifedipine
Drug: Labetalol
Drug: Atenolol

Study type

Observational

Funder types

Other

Identifiers

NCT04755764
1681431

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Morgan Ruley, MS; Jesse Cottrell, MD

Data sourced from clinicaltrials.gov

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