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Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Recruiting
CT.gov ID
NCT04790279
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
17.7
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial
Actual Study Start Date :
Apr 11, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Amlodipine

Drug: Amlodipine
Initiation of amlodipine 2.5 mg
Active Comparator: Nifedipine ER

Drug: NIFEdipine ER
Initiation of nifedipine ER 30 mg

Outcome Measures

Primary Outcome Measures

  1. Length of stay [Through hospital stay, on average 2-5 days]

    length of stay from delivery until discharge

Secondary Outcome Measures

  1. Number of additional antihypertensives needed [Through hospital stay, on average 2-5 days]

  2. Number of side effects reported by patient [Through hospital stay, on average 2-5 days]

  3. Number of patients discontinuing medication due to side effects [Through hospital stay, on average 2-5 days]

  4. Number of patients requiring hospital readmission [until 6 weeks postpartum]

  5. Breastfeeding duration [until 6 weeks postpartum]

  6. Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire [until 6 weeks postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Greenville Memorial Hospital Greenville South Carolina United States 29605

Sponsors and Collaborators

  • Prisma Health-Upstate

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT04790279
Other Study ID Numbers:
  • Pro00106643
First Posted:
Mar 10, 2021
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Hypertension
Amlodipine
Nifedipine

Study Results

No Results Posted as of Sep 17, 2021