Preeclampsia Postpartum Antihypertensive Treatment
The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.
Conditions:
🦠 Preeclampsia 🦠 Hypertension in Pregnancy
🗓️ Study Start (Actual) 17 July 2020
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 June 2024
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age \>= 18 years old
    • * Immediately postpartum (delivered in previous 96 hours)
    • * Diagnosed with preeclampsia during pregnancy, labor or immediately postpartum
    • * \>30% of blood pressures in the postpartum period were elevated (systolic 140 or higher OR diastolic 90 or higher)

    Exclusion Criteria:

    • * Chronic hypertension with superimposed preeclampsia
    • * Diagnosis of preeclampsia after discharge from delivery hospitalization
    • * Persistent severe range blood pressures after delivery requiring initiation of antihypertensive regimen by the care team
    • * \>50% of blood pressures in the postpartum period were normal (systolic less than 140 AND diastolic less than 90)
Ages Eligible for Study: 18 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 4 March 2020
  • First Submitted that Met QC Criteria 4 March 2020
  • First Posted 6 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 January 2023
  • Last Update Posted 4 January 2023
  • Last Verified January 2023