Clinical trial NCT04790279: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Length of Stay
timeFrame: Through hospital stay, on average 2-5 days
Secondary outcomes:
measure: Number of Acute Treatments After Medication Initiation
timeFrame: Through hospital stay, on average 2-5 days
measure: Patient Reported Side Effects
timeFrame: Through hospital stay, on average 2-5 days
measure: Number of Patients Discontinuing Medication Due to Side Effects
timeFrame: Through hospital stay, on average 2-5 days
measure: Number of Patients Requiring Hospital Readmission
timeFrame: until 6 weeks postpartum
measure: Breastfeeding Duration of 6+ Weeks
timeFrame: until 6 weeks postpartum
measure: Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire
timeFrame: until 6 weeks postpartum
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Katelyn Pratt, MD
role: STUDY_CHAIR
References:
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.
citation: ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
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.
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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.
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.
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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.
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.