Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

NCT04790279 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00106643
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  length of stay from delivery until discharge

  Through hospital stay, on average 2-5 days

Secondary Outcomes (6)

• Number of Acute Treatments After Medication Initiation

  Through hospital stay, on average 2-5 days

• Patient Reported Side Effects

  Through hospital stay, on average 2-5 days

• Number of Patients Discontinuing Medication Due to Side Effects

  Through hospital stay, on average 2-5 days

• Number of Patients Requiring Hospital Readmission

  until 6 weeks postpartum

• Breastfeeding Duration of 6+ Weeks

  until 6 weeks postpartum

Study Arms (2)

Amlodipine

EXPERIMENTAL

Drug: Amlodipine

Nifedipine ER

ACTIVE COMPARATOR

Drug: NIFEdipine ER

Interventions

Amlodipine DRUG

Initiation of amlodipine 2.5 mg

Amlodipine

NIFEdipine ER DRUG

Initiation of nifedipine ER 30 mg

Nifedipine ER

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of antihypertensive prior to delivery (for any indication)
• Allergy to nifedipine ER or amlodipine
• Persistent tachycardia (as defined by the treatment team)

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Related Publications (10)

• 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.

  PMID: 24150027 BACKGROUND

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

  PMID: 30575675 BACKGROUND

• 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.

  PMID: 30575676 BACKGROUND

• 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.

  PMID: 31489020 BACKGROUND

• 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.

  PMID: 23633317 BACKGROUND

• 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.

  PMID: 29187414 BACKGROUND

• 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.

  PMID: 27786578 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 1534716 BACKGROUND

• 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.

  PMID: 25447596 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Katelyn Pratt
• Organization: Prisma Health Upstate

katelyn.pratt@prismahealth.org

2176223524

Study Officials

• Katelyn Pratt, MD

  Prisma Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 10, 2021
• Study Start: April 9, 2021
• Primary Completion: December 13, 2022
• Study Completion: January 25, 2023
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)