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

NCT ID: NCT04755764

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-03

Study Completion Date

2025-12-31

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beta blockade

Beta blocker (labetalol or atenolol) will be given for a cardiac output \>8 l/min.

Labetalol

Intervention Type DRUG

Beta blocker

Atenolol

Intervention Type DRUG

Beta blocker

Nifedipine

Nifedipine will be given for a mean arterial pressure \>100.

Nifedipine

Intervention Type DRUG

Calcium channel blocker

Interventions

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Labetalol

Beta blocker

Intervention Type DRUG

Atenolol

Beta blocker

Intervention Type DRUG

Nifedipine

Calcium channel blocker

Intervention Type DRUG

Other Intervention Names

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Normodyne Trandate Tenormin Adalat CC Afeditab CR Nifediac CC Nifedical XL Procardia Procardia XL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Marshall University

OTHER

Sponsor Role lead

Responsible Party

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Jesse Cottrell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesse Cottrell, MD

Role: PRINCIPAL_INVESTIGATOR

Marshall University

Locations

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Maternal Hypertension Center at Cabell Huntington Hospital

Huntington, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Morgan Ruley, MS

Role: CONTACT

(304) 691-1458

Jesse Cottrell, MD

Role: CONTACT

(304) 691-1400

Facility Contacts

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Jesse Cottrell, MD

Role: primary

3046911400

Morgan Ruley, MS

Role: backup

3046911458

Other Identifiers

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1681431

Identifier Type: -

Identifier Source: org_study_id

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