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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Labetalol
* Drug: Atenolol
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Beta blockade<br>Beta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min. | Drug: Labetalol<br>* Beta blocker<br>* Other names: Trandate;Drug: Atenolol<br>* Beta blocker<br>* Other names: Tenormin;|
| Nifedipine<br>Nifedipine will be given for a mean arterial pressure >100. | Drug: Nifedipine<br>* Calcium channel blocker<br>* Other names: Procardia XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Measured in mmHg | Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. | 
| Diastolic blood pressure | Measured in mmHg | Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. | 
| Mean arterial pressure | Measured in mmHg | Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later. | 
| 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. | 
| 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. | 
| 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. |