Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Last updated: October 24, 2024
Sponsor: Prisma Health-Upstate
Overall Status: Completed

Phase

4

Condition

Diabetes And Hypertension

Stress

High Blood Pressure (Hypertension - Pediatric)

Treatment

Amlodipine

NIFEdipine ER

Clinical Study ID

NCT04790279
Pro00106643
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 systolicand/or 100 mmHg diastolic on two occasions four hours apart or isolated bloodpressure >160/110 mmHg

  • English or Spanish-speaking

  • Age 18 years or older

Exclusion

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)

Study Design

Total Participants: 175
Treatment Group(s): 2
Primary Treatment: Amlodipine
Phase: 4
Study Start date:
April 09, 2021
Estimated Completion Date:
January 25, 2023

Connect with a study center

  • Greenville Memorial Hospital

    Greenville, South Carolina 29605
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.