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OpenTrials
Completed

NCT Number: NCT04790279

Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

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.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Amlodipine

Drug

Initiation of amlodipine 2.5 mg

NIFEdipine ER

Drug

Initiation of nifedipine ER 30 mg

Primary outcomes

  1. Length of Stay

    Time frame: Through hospital stay, on average 2-5 days

    length of stay from delivery until discharge

Secondary outcomes

  1. Number of Acute Treatments After Medication Initiation

    Time frame: Through hospital stay, on average 2-5 days

  2. Patient Reported Side Effects

    Time frame: 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

  3. Number of Patients Discontinuing Medication Due to Side Effects

    Time frame: Through hospital stay, on average 2-5 days

  4. Number of Patients Requiring Hospital Readmission

    Time frame: until 6 weeks postpartum

  5. Breastfeeding Duration of 6+ Weeks

    Time frame: until 6 weeks postpartum

  6. Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire

    Time frame: until 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 10, 2021
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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