Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prisma Health-Upstate
• Treatments: Amlodipine; Nifedipine

Criteria

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

• 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)