Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
Primary Purpose
Hypertension in Pregnancy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amlodipine
NIFEdipine ER
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension in Pregnancy
Eligibility Criteria
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)
Sites / Locations
- Greenville Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amlodipine
Nifedipine ER
Arm Description
Outcomes
Primary Outcome Measures
Length of stay
length of stay from delivery until discharge
Secondary Outcome Measures
Number of additional antihypertensives needed
Number of side effects reported by patient
Number of patients discontinuing medication due to side effects
Number of patients requiring hospital readmission
Breastfeeding duration
Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04790279
Brief Title
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
Official Title
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amlodipine
Arm Type
Experimental
Arm Title
Nifedipine ER
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Initiation of amlodipine 2.5 mg
Intervention Type
Drug
Intervention Name(s)
NIFEdipine ER
Intervention Description
Initiation of nifedipine ER 30 mg
Primary Outcome Measure Information:
Title
Length of stay
Description
length of stay from delivery until discharge
Time Frame
Through hospital stay, on average 2-5 days
Secondary Outcome Measure Information:
Title
Number of additional antihypertensives needed
Time Frame
Through hospital stay, on average 2-5 days
Title
Number of side effects reported by patient
Time Frame
Through hospital stay, on average 2-5 days
Title
Number of patients discontinuing medication due to side effects
Time Frame
Through hospital stay, on average 2-5 days
Title
Number of patients requiring hospital readmission
Time Frame
until 6 weeks postpartum
Title
Breastfeeding duration
Time Frame
until 6 weeks postpartum
Title
Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire
Time Frame
until 6 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24150027
Citation
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
Results Reference
background
PubMed Identifier
30575675
Citation
ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
Results Reference
background
PubMed Identifier
30575676
Citation
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 203: Chronic Hypertension in Pregnancy. Obstet Gynecol. 2019 Jan;133(1):e26-e50. doi: 10.1097/AOG.0000000000003020.
Results Reference
background
PubMed Identifier
31489020
Citation
Ainuddin J, Javed F, Kazi S. Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1428-1433. doi: 10.12669/pjms.35.5.812.
Results Reference
background
PubMed Identifier
23633317
Citation
Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.
Results Reference
background
PubMed Identifier
29187414
Citation
Cairns AE, Pealing L, Duffy JMN, Roberts N, Tucker KL, Leeson P, MacKillop LH, McManus RJ. Postpartum management of hypertensive disorders of pregnancy: a systematic review. BMJ Open. 2017 Nov 28;7(11):e018696. doi: 10.1136/bmjopen-2017-018696.
Results Reference
background
PubMed Identifier
27786578
Citation
Sharma KJ, Greene N, Kilpatrick SJ. Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):44-47. doi: 10.1080/10641955.2016.1231317. Epub 2016 Oct 27.
Results Reference
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Citation
8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate.
Results Reference
background
PubMed Identifier
1534716
Citation
Hosie J, Bremner AD, Fell PJ, James IG, Saul PA, Taylor SH. Comparison of early side effects with amlodipine and nifedipine retard in hypertension. Cardiology. 1992;80 Suppl 1:54-9. doi: 10.1159/000175048.
Results Reference
background
PubMed Identifier
25447596
Citation
Naito T, Kubono N, Deguchi S, Sugihara M, Itoh H, Kanayama N, Kawakami J. Amlodipine passage into breast milk in lactating women with pregnancy-induced hypertension and its estimation of infant risk for breastfeeding. J Hum Lact. 2015 May;31(2):301-6. doi: 10.1177/0890334414560195. Epub 2014 Dec 1.
Results Reference
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Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
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