Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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. |
Drug: NIFEdipine ER
Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
|
| 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. |
Drug: Enalapril
Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
|
Outcome Measures
Primary Outcome Measures
- Prolonged hospitalization [up to six weeks postpartum]
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
- Unscheduled clinic appointment [up to six weeks postpartum]
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 [up to six weeks postpartum]
Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
- Postpartum readmission [up to six weeks postpartum]
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
- Increase in antihypertensives [up to six weeks postpartum]
Participants who need their antihypertensive increased in dose or frequency or if another antihypertensive is added to the regimen in the postpartum period
Secondary Outcome Measures
- Time to blood pressure control [up to six weeks postpartum]
Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)
- Need for additional antihypertensives [up to six weeks postpartum]
Any time a patient needs a second or third agent added to her antihypertensive regimen
- Time to discharge [up to six weeks postpartum]
The hours a patient stays in the hospital after delivery or after readmission for postpartum hypertension
- Clinically significant hypotension or hypertension [up to six weeks postpartum]
Any time a patient became symptomatic from her blood pressure as noted by her providers
- Serial creatinine values [up to six weeks postpartum]
Creatinine measured at one week from discharged and six weeks postpartum
- Continued need for antihypertensive [up to six weeks postpartum]
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
- Side effects [up to six weeks postpartum]
A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication
- Compliance [up to six weeks postpartum]
The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Thomas McElrath, MD, PhD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019P002981