ClinicalTrials.gg
RecruitingNCT04755764Updated May 13, 2025

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

An observational study in Systolic Hypertension, Pregnancy Related and Diastolic Hypertension, sponsored by Marshall University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Marshall University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Systolic Hypertension
  • Pregnancy Related
  • Diastolic Hypertension
  • Cardiac Output, Low
  • Cardiac Output, High
03

In context

Isolated Systolic Hypertension

35 studies on the registry are indexed under Isolated Systolic Hypertension; 8 are open to participants now.

Browse Isolated Systolic Hypertension studies →

Lead sponsor

Marshall University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients presenting to Maternal Hypertension Center at Cabell Huntington Hospital
  • English speaking
  • 18-45 years old.
  • Willing to provide
  • Gestational age prior to 15 weeks gestation

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Beta blockade

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

    Drug: Labetalol · Drug: Atenolol

  • Nifedipine

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

    Drug: Nifedipine

Interventions

  • Beta blocker

    Also known as: Normodyne, Trandate

  • Beta blocker

    Also known as: Tenormin

  • Calcium channel blocker

    Also known as: Adalat CC, Afeditab CR, Nifediac CC, Nifedical XL, Procardia, Procardia XL

06

What researchers measure

Primary outcomes

  1. Systolic blood pressure

    Measured in mmHg

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

  2. Diastolic blood pressure

    Measured in mmHg

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

  3. Mean arterial pressure

    Measured in mmHg

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

  4. Heart rate

    Measured in beats per minute

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

  5. Cardiac output

    Measured in liters per minute

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

  6. Systemic vascular resistance

    Measured by dynes · sec/cm\^-5

    Time frame: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

07

Study locations

1 of 1 sites recruiting
  • Maternal Hypertension Center at Cabell Huntington Hospital
    Huntington, West Virginia 25701, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2021 (actual). Primary completion is estimated for Dec 2025, 57 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2021
First posted
Feb 16, 2021
StartActual
Mar 3, 2021
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
May 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04755764
Lead sponsor
Marshall University
Responsible party
Jesse Cottrell (Assistant Professor, Marshall University) — Principal investigator
First posted
Feb 16, 2021
Start date
Mar 3, 2021
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 13, 2025

Study contacts

Morgan Ruley, MS
Contact
kelley115@marshall.edu
(304) 691-1458
Jesse Cottrell, MD
Contact
cottrellje@marshall.edu
(304) 691-1400
Jesse Cottrell, MD
principal investigator · Marshall University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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