Treatment of Elevated Blood Pressures in Early Pregnancy

  • STATUS
    Recruiting
  • participants needed
    234
  • sponsor
    Marshall University
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Updated on 20 July 2023
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Summary

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

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).

Details
Condition Elevated Blood Pressure, Pregnancy Induced Hypertension
Age 18years - 45years
Treatment Nifedipine, Labetalol, Labetalol
Clinical Study IdentifierNCT05955040
SponsorMarshall University
Last Modified on20 July 2023

Eligibility

 Yes No Not Sure

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
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