Actively Recruiting
Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
Led by Nebraska Methodist Health System · Updated on 2025-10-22
850
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
Nebraska Methodist Health System
Lead Sponsor
M
Methodist Hospital Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, randomized controlled trial to compare two blood pressure medications, nifedipine and enalapril, for managing hypertension in women after childbirth. This equivalence study aims to determine if both medications are similarly safe and effective in controlling postpartum hypertension and preventing hospital readmission due to hypertensive complications. Women admitted for delivery with either chronic or pregnancy-related hypertension are eligible for participation. Participants will be randomly assigned to receive either nifedipine extended release 30mg twice daily or enalapril 10mg once daily. Treatment duration and any changes in medication dosing or additional therapies will be determined by the participant's primary healthcare provider. The study focuses solely on which medication is started, with further management at the provider's discretion. During the study, participants will be monitored for hospital readmission within six weeks after delivery to evaluate the effectiveness of the assigned medication. The trial will track outcomes related to blood pressure control and any complications requiring readmission. The total participation length includes the postpartum period with follow-up during these six weeks to assess safety and treatment impact.
CONDITIONS
Brief Title
Postpartum Evaluation of Nifedipine and Enalapril for Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted for delivery by cesarean or vaginal delivery
- At 24 weeks gestation or greater
- Diagnosed with pregnancy-related hypertension or chronic hypertension, defined as systolic blood pressure 6140 mmHg or diastolic blood pressure 6190 mmHg on two occasions at least 4 hours apart
You will not qualify if you...
- Absolute contraindication to either nifedipine or enalapril
- Persistent heart rate less than 60 or greater than 110
- Native language other than English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration dictated by primary provider
Participants receive either nifedipine or enalapril to manage postpartum hypertension. The duration of treatment is determined by their primary provider.
Trial Site Locations
Total: 1 location
1
Methodist Women's Hospital
Omaha, Nebraska, United States, 68022
Actively Recruiting
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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