Postpartum Evaluation of Nifedipine and Enalapril for Hypertension
NCT ID: NCT07023003
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
850 participants
INTERVENTIONAL
2025-07-11
2028-12-31
Brief Summary
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Investigators will identify and offer enrollment to women who are admitted for delivery with documented hypertension- participants with either chronic hypertension or pregnancy related hypertension will be included. Our hypothesis is both medications are safe and effective in managing blood pressure and preventing readmission for hypertensive complications during the postpartum period so evaluating the rate of readmission is the primary goal of the study.
The only intervention of the trial will be to assign which medication the participant starts taking. Any decisions after that point- stopping medication, changing doses, additional medications, discharge from the hospital, etc, will all be at the discretion of the participant's primary provider.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nifedipine XR
Patients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider.
Nifedipine 30mg XL BID
Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Enalapril 10mg QD
Patients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider.
Enalapril 10mg QD
Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Interventions
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Enalapril 10mg QD
Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Nifedipine 30mg XL BID
Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 24 weeks gestation or greater
3. Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy related 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 in patients without CHTN.
Exclusion Criteria
2. Persistent HR \<60 or \>110
3. Native language other than English
19 Years
FEMALE
No
Sponsors
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Methodist Hospital Foundation
UNKNOWN
Nebraska Methodist Health System
OTHER
Responsible Party
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Todd Lovgren
Principal Investigator
Principal Investigators
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Todd Lovgren, MD
Role: PRINCIPAL_INVESTIGATOR
Nebraska Methodist Health System
Locations
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Methodist Women's Hospital
Omaha, Nebraska, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB 1551
Identifier Type: -
Identifier Source: org_study_id
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