Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
Conditions:
🦠 Postpartum Preeclampsia 🦠 Hypertension in Pregnancy
🗓️ Study Start (Actual) 20 June 2022
🗓️ Primary Completion (Estimated) 1 May 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 600
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Omaha, Nebraska, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). Hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension.

    Exclusion Criteria:

    • History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema
    • * Contraindication to either Nifedipine or Labetalol
    • * HR \<60 or \>110
    • * Native language other than English or Spanish
Ages Eligible for Study: 19 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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 25 March 2022
  • First Submitted that Met QC Criteria 25 March 2022
  • First Posted 4 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 April 2024
  • Last Update Posted 12 April 2024
  • Last Verified April 2024