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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Prolonged Hospitalization
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
Time frame: up to six weeks postpartum
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
Time frame: up to six weeks postpartum
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
Time frame: up to six weeks postpartum
Postpartum Readmission
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
Time frame: up to six weeks postpartum
Time to Blood Pressure Control
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
Number of Participants Who Needed for Additional Antihypertensives
Any time a patient needs a second or third agent added to her antihypertensive regimen
Time frame: up to six weeks postpartum
Time to Discharge
The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension
Time frame: up to six weeks postpartum
Clinically Significant Hypotension or Hypertension
Any time a patient became symptomatic from her blood pressure as noted by her providers
Time frame: up to six weeks postpartum
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)
Time frame: 1-2 weeks
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
Time frame: up to six weeks postpartum
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
Time frame: up to six weeks postpartum
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")
Time frame: up to six weeks postpartum
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)
Time frame: 6 weeks after delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.