Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Labetalol, Atenolol, Nifedipine.
- Who it may be relevant to
- Registry conditions: Systolic Hypertension, Pregnancy Related, Diastolic Hypertension, Cardiac Output, Low. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography in Early Pregnancy
Overview
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
- Drug Labetalol
Beta blocker - Drug Atenolol
Beta blocker - Drug Nifedipine
Calcium channel blocker
Primary outcome measures
- Systolic blood pressure [Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]
- Diastolic blood pressure [Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]
- Mean arterial pressure [Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]
- Heart rate [Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]
- Cardiac output [Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]
- Systemic vascular resistance [Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Maternal Hypertension Center at Cabell Huntington Hospital — Huntington
Identifiers
NCT: NCT04755764 · 1681431