Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Phase 4

Completed

• Conditions: Hypertension in Pregnancy
• Interventions: Drug: Amlodipine; Drug: NIFEdipine ER

• Registration Number: NCT04790279
• Lead Sponsor: Prisma Health-Upstate

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Study Start: 2021-04-09
• Status Verified: 2022-12
• Primary Completion: 2022-12-13
• Study Completion: 2023-01-25
• Results First Submitted: 2024-08-19
• Results First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Results First Posted: 2024-10-28
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 175

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine	Amlodipine	-
Nifedipine ER	NIFEdipine ER	-

Primary Outcome Measures

Name	Time	Method
Length of Stay	Through hospital stay, on average 2-5 days	length of stay from delivery until discharge

Secondary Outcome Measures

Name	Time	Method
Number of Acute Treatments After Medication Initiation	Through hospital stay, on average 2-5 days
Patient Reported Side Effects	Through hospital stay, on average 2-5 days	Side effects based on patient reported survey where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always
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 of 6+ Weeks	until 6 weeks postpartum
Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire	until 6 weeks postpartum

Trial Locations

Locations (1)

Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States