## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** Pro00106643
#### Organization
**Class:** OTHER
**Full Name:** Prisma Health-Upstate
### Status Module
#### Completion Date
**Date:** 2023-01-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-27

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-13

**Type:** ACTUAL

#### Start Date
**Date:** 2021-04-09

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2021-03-10
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-03
**Study First Submit QC Date:** 2021-03-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Prisma Health-Upstate

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

### Description Module

**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 Module

**Conditions:**

- Hypertension in Pregnancy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 132

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Amlodipine

**Label:** Amlodipine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: NIFEdipine ER

**Label:** Nifedipine ER

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Amlodipine

**Description:** Initiation of amlodipine 2.5 mg

**Name:** Amlodipine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Nifedipine ER

**Description:** Initiation of nifedipine ER 30 mg

**Name:** NIFEdipine ER

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** length of stay from delivery until discharge

**Measure:** Length of stay

**Time Frame:** Through hospital stay, on average 2-5 days

#### Secondary Outcomes

**Measure:** Number of additional antihypertensives needed

**Time Frame:** Through hospital stay, on average 2-5 days

**Measure:** Number of side effects reported by patient

**Time Frame:** Through hospital stay, on average 2-5 days

**Measure:** Number of patients discontinuing medication due to side effects

**Time Frame:** Through hospital stay, on average 2-5 days

**Measure:** Number of patients requiring hospital readmission

**Time Frame:** until 6 weeks postpartum

**Measure:** Breastfeeding duration

**Time Frame:** until 6 weeks postpartum

**Measure:** Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire

**Time Frame:** until 6 weeks postpartum

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Greenville

**Country:** United States

**Facility:** Greenville Memorial Hospital

**State:** South Carolina

**Zip:** 29605

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 24150027

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

**PMID:** 30575675

**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.

**PMID:** 30575676

**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.

**PMID:** 31489020

**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.

**PMID:** 23633317

**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.

**PMID:** 29187414

**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.

**PMID:** 27786578

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

**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.

**PMID:** 1534716

**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.

**PMID:** 25447596

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: HIGH

- As Found: Hypertension in Pregnancy

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000000959

- Term: Antihypertensive Agents

- ID: D000002121

- Term: Calcium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M19600

- Name: Amlodipine

- Relevance: HIGH

- As Found: Energy

- ID: M12483

- Name: Nifedipine

- Relevance: HIGH

- As Found: Elevated

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5384

- Name: Calcium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017311

- Term: Amlodipine

- ID: D000009543

- Term: Nifedipine

### Misc Info Module

- Version Holder: 2024-05-24
