Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Study Overview
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Brief Summary
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A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension in the postpartum period.

Official Title
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Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial

Conditions
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Hypertension in Pregnancy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postpartum women with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia Delivery at or beyond 20 weeks' gestation Need for antihypertensive therapy, defined as blood pressure >/= 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four hours apart or isolated blood pressure >160/110 mmHg English or Spanish-speaking Age 18 years or older Exclusion Criteria: Use of antihypertensive prior to delivery (for any indication) Allergy to nifedipine ER or amlodipine Persistent tachycardia (as defined by the treatment team)

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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No

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 |
| --- | --- |
| Experimental: Amlodipine<br> | Drug: Amlodipine<br>* Initiation of amlodipine 2.5 mg<br>|
| Active Comparator: Nifedipine ER<br> | Drug: NIFEdipine ER<br>* Initiation of nifedipine ER 30 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | length of stay from delivery until discharge | Through hospital stay, on average 2-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of additional antihypertensives needed |  | Through hospital stay, on average 2-5 days | 
| Number of side effects reported by patient |  | Through hospital stay, on average 2-5 days | 
| Number of patients discontinuing medication due to side effects |  | Through hospital stay, on average 2-5 days | 
| Number of patients requiring hospital readmission |  | until 6 weeks postpartum | 
| Breastfeeding duration |  | until 6 weeks postpartum | 
| Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire |  | until 6 weeks postpartum |