Treatment of Elevated Blood Pressures in Early Pregnancy
Overview
- Phase
- Phase 2
- Intervention
- Nifedipine
- Conditions
- Elevated Blood Pressure
- Sponsor
- Marshall University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Treatment of elevated blood pressures
- Status
- Terminated
- Last Updated
- last year
Overview
Brief 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).
Investigators
Jesse Cottrell
Assistant Professor of Maternal Fetal Medicine
Marshall University
Eligibility Criteria
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
Arms & Interventions
Treatment Group
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Intervention: Nifedipine
Treatment Group
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Intervention: Labetalol
Outcomes
Primary Outcomes
Treatment of elevated blood pressures
Time Frame: through study completion, an average of 1 year
NICU days
Secondary Outcomes
- ICG directed treatment(through study completion, an average of 1 year)