Postpartum management of hypertension and effect on readmission rates.
Todd Lovgren, Brendan Connealy, Ruofan Yao...
https://pubmed.ncbi.nlm.nih.gov/34757235Actively Recruiting
Phase 4
Age: 19Years +
FEMALE
ID05309460
Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
Led by Nebraska Methodist Health System · Updated on 2024-04-12
600
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates postpartum hypertension management by comparing the risk of hospital readmission and hypertensive complications in patients treated with Labetalol versus Nifedipine. It is a randomized controlled trial enrolling patients admitted for delivery at 24 weeks gestation or later who have hypertension defined by specific blood pressure thresholds. The study aims to evaluate which medication better controls postpartum hypertension and reduces readmission risks. Participants are randomly assigned to one of two treatment groups. In the Nifedipine arm, patients start on extended-release Nifedipine 30mg twice daily, with dose escalation by the primary provider up to 120mg daily. If hypertension persists, Labetalol is added. In the Labetalol arm, patients start at 200mg three times daily, with escalation up to 2400mg daily; if higher doses are not tolerated due to bradycardia, Nifedipine is added. Patients are monitored for side effects and signs of low blood pressure, and hospitalization is not extended solely for study purposes. Participants undergo outpatient follow-up as directed by their care provider. At six months, researchers contact patients to check for hospital readmissions and review medical records for emergency evaluations or readmissions. The primary outcome is hospital readmission within six months. Secondary outcomes include medication failure and changes or discontinuation within six months. Safety is overseen by a monitoring board reviewing data every six months, with study termination planned if significant differences arise.
CONDITIONS
Brief Title
Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
Who Can Participate
Age: 19Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients admitted for delivery at 24 weeks gestation or greater with hypertension
- Hypertension defined as systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart
- Age 19 years or older
- Ability to speak English or Spanish
- Consent to participate in the study
You will not qualify if you...
- History of moderate persistent asthma
- History of coronary artery disease
- History of heart failure
- History of AV heart block
- History of pulmonary edema
- Contraindication to either Nifedipine or Labetalol
- Heart rate less than 60 or greater than 110 beats per minute
- Native language other than English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until normotension is achieved for at least 12 hours before discharge
Participants receive either Nifedipine XR or Labetalol to control postpartum hypertension with dose adjustments as needed by their primary provider. They are monitored for side effects but are not kept hospitalized for study purposes.
Visits determined by clinical care, no additional study visits required
Follow-up
Duration - 6 months
Participants are followed after discharge with outpatient care as dictated by their provider and contacted at 6 months to assess readmission and emergency room evaluations.
1 phone call at 6 months
Trial Site Locations
Total: 1 location
1
Nebraska Methodist Women's Hospital
Omaha, Nebraska, United States, 68022
Actively Recruiting
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Research Team
T
Todd Lovgren, MD
J
Joshua Dahlke, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Postpartum medical management of hypertension and risk of readmission for hypertensive complications.
Todd Lovgren, Brendan Connealy, Ruofan Yao...
https://pubmed.ncbi.nlm.nih.gov/36511111