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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

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

Intervention / Treatment
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* Drug: NIFEdipine ER
* Drug: Enalapril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nifedipine<br>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<br>* Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.<br>|
| Active Comparator: Enalapril<br>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<br>* Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged Hospitalization | Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery | 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 | 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 | up to six weeks postpartum | 
| Postpartum Readmission | Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period | up to six weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Blood Pressure Control | Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours) | 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 | up to six weeks postpartum | 
| Time to Discharge | The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension | 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 | 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) | 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 | 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 | 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) | 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) | 6 weeks after delivery |