Clinical trial NCT04755764: Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
Official title: The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography in Early Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systolic Hypertension
Pregnancy Related
Diastolic Hypertension
Cardiac Output, Low
Cardiac Output, High
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Maternal Hypertension Center at Cabell Huntington Hospital. Consent will be obtained prior to enrollment. Patient age range will be from age 18 to approximately 45.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
measure: Diastolic blood pressure
timeFrame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
measure: Mean arterial pressure
timeFrame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
measure: Heart rate
timeFrame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
measure: Cardiac output
timeFrame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
measure: Systemic vascular resistance
timeFrame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Maternal Hypertension Center at Cabell Huntington Hospital
state: West Virginia
Study officials:
affiliation: Marshall University
name: Jesse Cottrell, MD
role: PRINCIPAL_INVESTIGATOR
References: