NCT04755764

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

January 27, 2021

Last Update Submit

May 9, 2025

Conditions

Systolic HypertensionPregnancy RelatedDiastolic HypertensionCardiac Output, LowCardiac Output, High

Outcome Measures

Primary Outcomes (6)

  • Systolic blood pressure

    Measured in mmHg

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

  • Diastolic blood pressure

    Measured in mmHg

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

  • Mean arterial pressure

    Measured in mmHg

    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

    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

    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

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

Study Arms (2)

Beta blockade

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

Drug: LabetalolDrug: Atenolol

Nifedipine

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

Drug: Nifedipine

Interventions

LabetalolDRUG

Beta blocker

Also known as: Normodyne, Trandate
Beta blockade
AtenololDRUG

Beta blocker

Also known as: Tenormin
Beta blockade
NifedipineDRUG

Calcium channel blocker

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Non-English speaking patients, patients
  • \<18 years old or \>45 years old
  • Not willing or able to provide consent
  • Gestational age \>15 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal Hypertension Center at Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

RECRUITING

MeSH Terms

Conditions

Isolated Systolic HypertensionCardiac Output, LowCardiac Output, High

Interventions

LabetalolAtenololNifedipine

Condition Hierarchy (Ancestors)

Essential HypertensionHypertensionVascular DiseasesCardiovascular DiseasesHeart DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesPhenoxypropanolaminesPropanolaminesPropanolsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jesse Cottrell, MD

    Marshall University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Ruley, MS

CONTACT

(304) 691-1458kelley115@marshall.edu

Jesse Cottrell, MD

CONTACT

(304) 691-1400cottrellje@marshall.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 16, 2021

Study Start

March 3, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

US(1)