- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236258
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.
Nifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
- provider wanting to initiate antihypertensive in the postpartum period
- the patient is not currently on >1 antihypertensive
- plans to receive postpartum care at the hospital or affiliated clinic
Exclusion Criteria:
- sustained pulse <60 or >120 BPM over four hours
- allergy to any of the antihypertensives
- creatinine greater than or equal to 1.5
- strict contraindication to any of the antihypertensives
- history of failed treatment with any of the antihypertensives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nifedipine
This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.
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Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
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Active Comparator: Enalapril
This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.
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Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolonged Hospitalization
Time Frame: up to six weeks postpartum
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Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
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up to six weeks postpartum
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Unscheduled Clinic Appointment
Time Frame: up to six weeks postpartum
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Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled
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up to six weeks postpartum
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Visit to Labor and Delivery Triage for Evaluation
Time Frame: up to six weeks postpartum
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Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
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up to six weeks postpartum
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Postpartum Readmission
Time Frame: up to six weeks postpartum
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Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
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up to six weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Blood Pressure Control
Time Frame: up to six weeks postpartum
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Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)
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up to six weeks postpartum
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Number of Participants Who Needed for Additional Antihypertensives
Time Frame: up to six weeks postpartum
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Any time a patient needs a second or third agent added to her antihypertensive regimen
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up to six weeks postpartum
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Time to Discharge
Time Frame: up to six weeks postpartum
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The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension
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up to six weeks postpartum
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Clinically Significant Hypotension or Hypertension
Time Frame: up to six weeks postpartum
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Any time a patient became symptomatic from her blood pressure as noted by her providers
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up to six weeks postpartum
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Creatinine Values at 1-2 Weeks After Discharge
Time Frame: 1-2 weeks
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Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)
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1-2 weeks
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Continued Need for Antihypertensive
Time Frame: up to six weeks postpartum
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If a patient still needs the prescribed antihypertensives one week after discharge and six weeks after delivery to control her blood pressure as determined by her provider during her clinic visit
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up to six weeks postpartum
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Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
Time Frame: up to six weeks postpartum
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A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication
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up to six weeks postpartum
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Patient Self-reported Compliance With Their Antihypertensive Regimen
Time Frame: up to six weeks postpartum
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The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives ("difficulty remembering to take the medication")
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up to six weeks postpartum
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Creatinine Level Around 6 Weeks After Delivery
Time Frame: 6 weeks after delivery
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Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)
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6 weeks after delivery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas McElrath, MD, PhD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Pregnancy Complications
- Hypertension
- Pre-Eclampsia
- Hypertension, Pregnancy-Induced
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Tocolytic Agents
- Enalapril
- Nifedipine
Other Study ID Numbers
- 2019P002981
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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