Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

Phase 4

Completed

Conditions: Hypertension in Pregnancy
Gestational Hypertension
Preeclampsia Severe
Postpartum Preeclampsia
Postpartum

Interventions: Drug: NIFEdipine ER
Drug: Enalapril

Registration Number: NCT04236258

Lead Sponsor: Brigham and Women's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 94

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine	NIFEdipine ER	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.
Enalapril	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.

Primary Outcome Measures

Name	Time	Method
Prolonged Hospitalization	up to six weeks postpartum	Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
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
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

Secondary Outcome Measures

Name	Time	Method
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)
Number of Participants Who Needed 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 days 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
Creatinine Values at 1-2 Weeks After Discharge	1-2 weeks	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	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
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received	up to six weeks postpartum	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	up to six weeks postpartum	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	6 weeks after delivery	Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)