Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Hypertension in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790279
• Other study ID #: Pro00106643
• Status: Completed
• Phase: Phase 4
• Start date: April 9, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: December 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 25, 2023
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

Drug:
• Amlodipine
Initiation of amlodipine 2.5 mg
• NIFEdipine ER
Initiation of nifedipine ER 30 mg

Locations

Country	Name	City	State
United States	Greenville Memorial Hospital	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

References & Publications (10)

8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate.

ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	length of stay from delivery until discharge	Through hospital stay, on average 2-5 days
Secondary	Number of additional antihypertensives needed		Through hospital stay, on average 2-5 days
Secondary	Number of side effects reported by patient		Through hospital stay, on average 2-5 days
Secondary	Number of patients discontinuing medication due to side effects		Through hospital stay, on average 2-5 days
Secondary	Number of patients requiring hospital readmission		until 6 weeks postpartum
Secondary	Breastfeeding duration		until 6 weeks postpartum
Secondary	Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire		until 6 weeks postpartum