Systolic HypertensionNCT04755764
Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
An observational study of Systolic Hypertension and Pregnancy Related, run by Marshall University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systolic Hypertension, Pregnancy Related, Diastolic Hypertension
- What is being tested?
- Labetalol, Atenolol and Nifedipine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Non-English speaking patients, patients
- <18 years old or >45 years old
- Not willing or able to provide consent
- Gestational age >15 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maternal Hypertension Center at Cabell Huntington Hospital
Huntington, West Virginia, 25701
Jesse Cottrell, MD, 3046911400, cottrellje@marshall.edu
Morgan Ruley, MS, 3046911458, kelley115@marshall.edu
About this study
Official title: The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography 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.
Read the 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.
- Conditions
- Systolic Hypertension, Pregnancy Related, Diastolic Hypertension, Cardiac Output, Low, Cardiac Output, High
- Being tested
- Labetalol, Atenolol, Nifedipine
- Medical subject headings
- Isolated Systolic Hypertension, Cardiac Output, Low, Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Also called Normodyne, Trandate
Beta blocker
AtenololDrug
Also called Tenormin
Beta blocker
NifedipineDrug
Also called Adalat CC, Afeditab CR, Nifediac CC, Nifedical XL
Calcium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Beta blockade | Beta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min. Receives: Drug: Labetalol; Drug: Atenolol | |
| Nifedipine | Nifedipine will be given for a mean arterial pressure >100. Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured in mmHg
Measured: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Diastolic blood pressure
Measured in mmHg
Measured: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Mean arterial pressure
Measured in mmHg
Measured: 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
Measured: 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
Measured: 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
Measured: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start3 Mar 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cottrell, Marshall University
- Investigators
- Jesse Cottrell, MD, Principal investigator, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755764
- Sponsor's protocol ID
- 1681431
- Status last verified
- May 2025
- First submitted
- 27 Jan 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography in Early Pregnancy
- ClinicalTrials.gov ID
- NCT04755764
- Acronym / sponsor ID
- 1681431
- Conditions
- Systolic Hypertension, Pregnancy Related, Diastolic Hypertension, Cardiac Output, Low, Cardiac Output, High
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta blockade | – | Drug: Labetalol, Drug: AtenololBeta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min. |
| Nifedipine | – | Drug: NifedipineNifedipine will be given for a mean arterial pressure >100. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Non-English speaking patients, patients
- <18 years old or >45 years old
- Not willing or able to provide consent
- Gestational age >15 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LabetalolAlso: Normodyne, TrandateBeta blocker | Drug | Beta blockade |
| AtenololAlso: TenorminBeta blocker | Drug | Beta blockade |
| NifedipineAlso: Adalat CC, Afeditab CR, Nifediac CC, Nifedical XLCalcium channel blocker | Drug | Nifedipine |
Primary outcome
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesse Cottrell, MD principal investigator
Marshall University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systolic Hypertension and Pregnancy Related, run by Marshall University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgan Ruley, MS ((304) 691-1458, kelley115@marshall.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.