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Treatment of Elevated Blood Pressures in Early Pregnancy | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Treatment of Elevated Blood Pressures in Early Pregnancy

NCT05955040•Marshall University

Summary

This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.

Detailed Description

Patients will be randomized to treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment. After randomization to treatment, patient's will be treated with either nifedipine or labetalol (both medications that are standard of care for treatment of elevated blood pressure during pregnancy). The purpose of this study is two-fold: 1) Determine if treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment improves maternal and fetal outcomes and 2) determine if ICG directed treatment is optimal as ICG will not be used to determine treatment medication (this will be done by secondary analysis after conclusion of the study).

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Patients presenting for obstetric care at Marshall University (Huntington office and Teays Valley office) between 12 and 16 weeks gestation with a systolic blood pressure of 120 or greater OR a diastolic blood pressure of 80 or greater. Eligibility for this study will be have blood pressures between 120-139 systolic and 80-89 diastolic. Randomization to control, labetalol, or nifedipine will be performed after patient consent.

Exclusion Criteria

•Patients already be on medication for hypertension.
•Patients with the diagnosis of chronic hypertension
•Patients with a BP of 140 or greater systolic OR 90 or greater diastolic (this meets criteria for chronic hypertension in pregnancy).
•Patients actively using any illicit substance or have history of substance use disorder.
•Patients who are actively consuming alcohol during pregnancy.
•Patients with Type I or Type II Diabetes Mellitus.
•Patients with end stage renal disease.
•Patients less then 12 weeks gestation or greater than 16 weeks

Locations (1)

Marshall Obstetrics and Gynecology

Huntington, West Virginia, United States

Key Dates

Start Date

July 11, 2023

Primary Completion Date

May 6, 2024

Completion Date

May 6, 2024

Last Updated

November 21, 2024

Enrollment

ACTUAL participants

Conditions

Elevated Blood PressurePregnancy Induced Hypertension

Interventions

Nifedipine

DRUG

Labetalol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Elevated Blood Pressures in Early Pregnancy

Inclusion Criteria

Exclusion Criteria

Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population

Office, Home, and Ambulatory Blood Pressure

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