NCT04790279

Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension in Pregnancy

Interventions

Type	Name	Description
DRUG	Amlodipine	Initiation of amlodipine 2.5 mg
DRUG	NIFEdipine ER	Initiation of nifedipine ER 30 mg

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-12-13
• Completion: 2023-01-25
• First posted: 2021-03-10
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study