Hypertension in PregnancyPhase 4NCT04790279
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
A Phase 4 study testing Amlodipine and NIFEdipine ER in people with Hypertension in Pregnancy, run by Prisma Health-Upstate at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Amlodipine and NIFEdipine ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 25 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Use of antihypertensive prior to delivery (for any indication)
- Allergy to nifedipine ER or amlodipine
- Persistent tachycardia (as defined by the treatment team)
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Memorial Hospital
Greenville, South Carolina, 29605
About this study
Official title: Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial
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
- Being tested
- Amlodipine, NIFEdipine ER
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Initiation of amlodipine 2.5 mg
NIFEdipine ERDrug
Initiation of nifedipine ER 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine | Experimental | Not described Receives: Drug: Amlodipine |
| Nifedipine ER | Active comparator | Not described Receives: Drug: NIFEdipine ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
length of stay from delivery until discharge
Measured: Through hospital stay, on average 2-5 days
Secondary outcomes (6)
Number of Acute Treatments After Medication Initiation
Measured: 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
Measured: Through hospital stay, on average 2-5 days
Number of Patients Discontinuing Medication Due to Side Effects
Measured: Through hospital stay, on average 2-5 days
Number of Patients Requiring Hospital Readmission
Measured: until 6 weeks postpartum
Breastfeeding Duration of 6+ Weeks
Measured: until 6 weeks postpartum
Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire
Measured: until 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start9 Apr 2021
- Primary completion13 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katelyn Pratt, MD, Study chair, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790279
- Sponsor's protocol ID
- Pro00106643
- Status last verified
- Dec 2022
- First submitted
- 3 Mar 2021
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24150027ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
PubMed 30575675American 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.
PubMed 30575676Ainuddin 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.
PubMed 31489020Magee 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.
PubMed 23633317Cairns 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.
PubMed 29187414Sharma 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.
PubMed 277865788. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate.
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.
PubMed 1534716Naito 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.
PubMed 25447596
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04790279
- Acronym / sponsor ID
- Pro00106643
- Conditions
- Hypertension in Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine | Experimental | Drug: Amlodipine |
| Nifedipine ER | Active comparator | Drug: NIFEdipine ER |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Use of antihypertensive prior to delivery (for any indication)
- Allergy to nifedipine ER or amlodipine
- Persistent tachycardia (as defined by the treatment team)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineInitiation of amlodipine 2.5 mg | Drug | Amlodipine |
| NIFEdipine ERInitiation of nifedipine ER 30 mg | Drug | Nifedipine ER |
Primary outcome
Length of Stay
Time frame: Through hospital stay, on average 2-5 days
length of stay from delivery until discharge
6 secondary outcomes
Number of Acute Treatments After Medication Initiation
Time frame: Through hospital stay, on average 2-5 days
Patient Reported Side Effects
Time frame: Through hospital stay, on average 2-5 days
Number of Patients Discontinuing Medication Due to Side Effects
Time frame: Through hospital stay, on average 2-5 days
Number of Patients Requiring Hospital Readmission
Time frame: until 6 weeks postpartum
Breastfeeding Duration of 6+ Weeks
Time frame: until 6 weeks postpartum
Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire
Time frame: until 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24150027Hypertension 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.
- Background: PubMed 30575675ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
- Background: PubMed 30575676American 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.
- Background: PubMed 31489020Ainuddin 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.
- Background: PubMed 23633317Magee 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.
- Background: PubMed 29187414Cairns 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.
- Background: PubMed 27786578Sharma 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.
- Background8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate.
- Background: PubMed 1534716Hosie 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.
- Background: PubMed 25447596Naito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katelyn Pratt, MD study chair
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine and NIFEdipine ER in people with Hypertension in Pregnancy, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: Through hospital stay, on average 2-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790279, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.