Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Prisma Health-Upstate

Status and phase: Completed; Phase 4

Conditions: Hypertension in Pregnancy

Treatments: Drug: NIFEdipine ER; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT04790279

Pro00106643

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Amlodipine

Experimental group

Treatment:

Drug: Amlodipine

Nifedipine ER

Active Comparator group

Treatment:

Drug: NIFEdipine ER