Treatment of Elevated Blood Pressures in Early Pregnancy
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.
Conditions:
🦠 Elevated Blood Pressure 🦠 Pregnancy Induced Hypertension
🗓️ Study Start (Actual) 11 July 2023
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 234
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Huntington, West Virginia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 June 2023
  • First Submitted that Met QC Criteria 11 July 2023
  • First Posted 20 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 October 2023
  • Last Update Posted 19 October 2023
  • Last Verified October 2023