Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
NCT ID: NCT04790279
Last Updated: 2024-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
175 participants
INTERVENTIONAL
2021-04-09
2023-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amlodipine
Amlodipine
Initiation of amlodipine 2.5 mg
Nifedipine ER
NIFEdipine ER
Initiation of nifedipine ER 30 mg
Interventions
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Amlodipine
Initiation of amlodipine 2.5 mg
NIFEdipine ER
Initiation of nifedipine ER 30 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* Allergy to nifedipine ER or amlodipine
* Persistent tachycardia (as defined by the treatment team)
18 Years
FEMALE
No
Sponsors
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Prisma Health-Upstate
OTHER
Responsible Party
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Principal Investigators
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Katelyn Pratt, MD
Role: STUDY_CHAIR
Prisma Health
Locations
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Greenville Memorial Hospital
Greenville, South Carolina, United States
Countries
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References
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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.
ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
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.
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.
Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.
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.
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.
8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00106643
Identifier Type: -
Identifier Source: org_study_id
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