Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Primary Purpose
Hypertension in Pregnancy, Preeclampsia Severe, Gestational Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NIFEdipine ER
Enalapril
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension in Pregnancy
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nifedipine
Enalapril
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Prolonged Hospitalization
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
Unscheduled Clinic Appointment
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
Visit to Labor and Delivery Triage for Evaluation
Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
Postpartum Readmission
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
Secondary Outcome Measures
Time to Blood Pressure Control
Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)
Number of Participants Who Needed for Additional Antihypertensives
Any time a patient needs a second or third agent added to her antihypertensive regimen
Time to Discharge
The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension
Clinically Significant Hypotension or Hypertension
Any time a patient became symptomatic from her blood pressure as noted by her providers
Creatinine Values at 1-2 Weeks After Discharge
Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)
Continued Need for Antihypertensive
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
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication
Patient Self-reported Compliance With Their Antihypertensive Regimen
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")
Creatinine Level Around 6 Weeks After Delivery
Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)
Full Information
NCT ID
NCT04236258
First Posted
January 16, 2020
Last Updated
November 10, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04236258
Brief Title
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Official Title
A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Preeclampsia Severe, Gestational Hypertension, Postpartum Preeclampsia, Postpartum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enalapril
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NIFEdipine ER
Intervention Description
Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Primary Outcome Measure Information:
Title
Prolonged Hospitalization
Description
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
Time Frame
up to six weeks postpartum
Title
Unscheduled Clinic Appointment
Description
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
Time Frame
up to six weeks postpartum
Title
Visit to Labor and Delivery Triage for Evaluation
Description
Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
Time Frame
up to six weeks postpartum
Title
Postpartum Readmission
Description
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
Time Frame
up to six weeks postpartum
Secondary Outcome Measure Information:
Title
Time to Blood Pressure Control
Description
Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)
Time Frame
up to six weeks postpartum
Title
Number of Participants Who Needed for Additional Antihypertensives
Description
Any time a patient needs a second or third agent added to her antihypertensive regimen
Time Frame
up to six weeks postpartum
Title
Time to Discharge
Description
The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension
Time Frame
up to six weeks postpartum
Title
Clinically Significant Hypotension or Hypertension
Description
Any time a patient became symptomatic from her blood pressure as noted by her providers
Time Frame
up to six weeks postpartum
Title
Creatinine Values at 1-2 Weeks After Discharge
Description
Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)
Time Frame
1-2 weeks
Title
Continued Need for Antihypertensive
Description
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
Time Frame
up to six weeks postpartum
Title
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
Description
A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication
Time Frame
up to six weeks postpartum
Title
Patient Self-reported Compliance With Their Antihypertensive Regimen
Description
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")
Time Frame
up to six weeks postpartum
Title
Creatinine Level Around 6 Weeks After Delivery
Description
Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)
Time Frame
6 weeks after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas McElrath, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.
IPD Sharing Time Frame
The data will be available for approximately six months after the study's conclusion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal Institutional Review Board.
Learn more about this trial
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
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