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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine | Experimental |
| |
| Nifedipine ER | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Initiation of amlodipine 2.5 mg |
| |
| NIFEdipine ER |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | length of stay from delivery until discharge | Through hospital stay, on average 2-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Acute Treatments After Medication Initiation | Through hospital stay, on average 2-5 days | |
| Patient Reported Side Effects | Side effects based on patient reported survey where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katelyn Pratt, MD | Prisma Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24150027 | Background | 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. | |
| 30575675 | Background | ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. |
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Patients were randomized at the time of enrollment. Only patients meeting pre-defined criteria were started on an anti-hypertensive.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine | Amlodipine: Initiation of amlodipine 2.5 mg |
| FG001 | Nifedipine ER | NIFEdipine ER: Initiation of nifedipine ER 30 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine | Patients randomized to amlodipine |
| BG001 | Nifedipine ER | Patients randomized to nifedipine ER |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Stay | length of stay from delivery until discharge | Amlodipine Intent To Treat | Posted | Median | 95% Confidence Interval | hours | Through hospital stay, on average 2-5 days |
|
|
Through 6 weeks postpartum
Only patients receiving at least one dose of assigned study medication are included
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amlodipine | Amlodipine: Initiation of amlodipine 2.5 mg | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katelyn Pratt | Prisma Health Upstate | 2176223524 | katelyn.pratt@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2022 | Aug 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2022 | Aug 16, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Initiation of nifedipine ER 30 mg |
|
| 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 |
| Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | until 6 weeks postpartum |
| 30575676 | 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. |
| 31489020 | 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. |
| 23633317 | 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. |
| 29187414 | 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. |
| 27786578 | 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. |
| Background | 8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate. |
| 1534716 | 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. |
| 25447596 | 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. |
| Protocol Violation |
|
| Developed complication requiring alternative regimen |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Data were not collected | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI at delivery | Mean | Standard Deviation | kg/m2 |
|
| Parity | Median | Full Range | number of deliveries |
|
| Gestational age at delivery | Mean | Standard Deviation | weeks |
|
| Mode of delivery | Number | participants |
|
| Hypertensive diagnosis | May have more than 1 diagnosis | Number | participants |
|
| Diabetes | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Acute Treatments After Medication Initiation | Patients who received at least 1 dose of assigned study medication at correct starting dose | Posted | Median | Standard Deviation | number acute treatments | Through hospital stay, on average 2-5 days |
|
|
|
| Secondary | Patient Reported Side Effects | Side effects based on patient reported survey where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always | Patients receiving at least 1 dose of assigned study medication at correct starting dose | Posted | Median | Standard Deviation | score on a scale | Through hospital stay, on average 2-5 days |
|
|
|
| Secondary | Number of Patients Discontinuing Medication Due to Side Effects | Posted | Count of Participants | Participants | Through hospital stay, on average 2-5 days |
|
|
|
| Secondary | Number of Patients Requiring Hospital Readmission | Posted | Count of Participants | Participants | until 6 weeks postpartum |
|
|
|
| Secondary | Breastfeeding Duration of 6+ Weeks | Only includes patients who answered relevant question on breastfeeding questionnaire | Posted | Count of Participants | Participants | until 6 weeks postpartum |
|
|
|
| Secondary | Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | Only includes patients who answered relevant question on breastfeeding questionnaire | Posted | Count of Participants | Participants | until 6 weeks postpartum |
|
|
|
| 53 |
| 4 |
| 53 |
| 19 |
| 53 |
| EG001 | Nifedipine ER | NIFEdipine ER: Initiation of nifedipine ER 30 mg | 0 | 69 | 4 | 69 | 26 | 69 |
| Prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Side effect requiring discontinuation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Triage/ER visit | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Pre-gestational |
|
| Headaches |
|
| Other |
|