Trial · NCT04790279
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
NCT04790279, Phase 4, Completed, Prisma Health-Upstate; results first posted 2024-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension. Trials, record NCT04790279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04790279
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
- NCT number
- NCT04790279
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 175 participants, actual
- Lead sponsor
- Prisma Health-Upstate
- Conditions
- Hypertension in Pregnancy
- Interventions
- Amlodipine, NIFEdipine ER
- First posted
- 2021-03-10
- Last updated
- 2024-10-28
- Results first posted
- 2024-10-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Stay | Through hospital stay, on average 2-5 days | length of stay from delivery until discharge |
| Secondary | Number of Acute Treatments After Medication Initiation | Through hospital stay, on average 2-5 days | |
| Secondary | Patient Reported Side Effects | Through hospital stay, on average 2-5 days | Side effects based on patient reported survey where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always |
| 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 of 6+ Weeks | until 6 weeks postpartum | |
| Secondary | Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | until 6 weeks postpartum |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Stay | Through hospital stay, on average 2-5 days | Amlodipine Intent To Treat | hours | MEDIAN |
| SECONDARY | Number of Acute Treatments After Medication Initiation | Through hospital stay, on average 2-5 days | Patients who received at least 1 dose of assigned study medication at correct starting dose | number acute treatments | MEDIAN |
| SECONDARY | Patient Reported Side Effects | Through hospital stay, on average 2-5 days | Patients receiving at least 1 dose of assigned study medication at correct starting dose | score on a scale | MEDIAN |
| SECONDARY | Number of Patients Discontinuing Medication Due to Side Effects | Through hospital stay, on average 2-5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Requiring Hospital Readmission | until 6 weeks postpartum | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Breastfeeding Duration of 6+ Weeks | until 6 weeks postpartum | Only includes patients who answered relevant question on breastfeeding questionnaire | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | until 6 weeks postpartum | Only includes patients who answered relevant question on breastfeeding questionnaire | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Stay | Amlodipine | 73.5 | 95% Confidence Interval 67.0 to 81.0 | hours | |
| Length of Stay | Nifedipine ER | 72.0 | 95% Confidence Interval 66.5 to 78.5 | hours | |
| Number of Acute Treatments After Medication Initiation | Amlodipine | 4.0 | Standard Deviation 2.7 | number acute treatments | |
| Number of Acute Treatments After Medication Initiation | Nifedipine ER | 1.5 | Standard Deviation 1.5 | number acute treatments | |
| Patient Reported Side Effects | Amlodipine | Flushing | 1.33 | Standard Deviation 0.72 | score on a scale |
| Patient Reported Side Effects | Nifedipine ER | Flushing | 1.60 | Standard Deviation 1.00 | score on a scale |
| Patient Reported Side Effects | Amlodipine | Swelling | 1.55 | Standard Deviation 1.16 | score on a scale |
| Patient Reported Side Effects | Nifedipine ER | Swelling | 1.71 | Standard Deviation 1.09 | score on a scale |
| Patient Reported Side Effects | Amlodipine | Headaches | 1.71 | Standard Deviation 1.06 | score on a scale |
| Patient Reported Side Effects | Nifedipine ER | Headaches | 1.98 | Standard Deviation 1.17 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine | 87 | |
| Overall Study | STARTED | Nifedipine ER | 88 | |
| Overall Study | COMPLETED | Amlodipine | 51 | |
| Overall Study | COMPLETED | Nifedipine ER | 69 | |
| Overall Study | NOT COMPLETED | Amlodipine | 36 | |
| Overall Study | NOT COMPLETED | Nifedipine ER | 19 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Amlodipine | 14 | 53 | |
| other | Prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Nifedipine ER | 11 | 69 | |
| other | Side effect requiring discontinuation | Pregnancy, puerperium and perinatal conditions | Amlodipine | 0 | 53 | |
| other | Side effect requiring discontinuation | Pregnancy, puerperium and perinatal conditions | Nifedipine ER | 7 | 69 | |
| other | Triage/ER visit | Pregnancy, puerperium and perinatal conditions | Amlodipine | 5 | 53 | |
| other | Triage/ER visit | Pregnancy, puerperium and perinatal conditions | Nifedipine ER | 9 | 69 | |
| serious | Readmission | Pregnancy, puerperium and perinatal conditions | Amlodipine | 3 | 53 | 3 |
| serious | Readmission | Pregnancy, puerperium and perinatal conditions | Nifedipine ER | 3 | 69 | 3 |
| serious | Prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Amlodipine | 1 | 53 | 1 |
| serious | Prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Nifedipine ER | 1 | 69 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine | 0 | 53 |
| Total, all-cause mortality | Nifedipine ER | 0 | 69 |
| Total, other adverse events | Amlodipine | 19 | 53 |
| Total, other adverse events | Nifedipine ER | 26 | 69 |
| Total, serious adverse events | Amlodipine | 4 | 53 |
| Total, serious adverse events | Nifedipine ER | 4 | 69 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amlodipine vs Nifedipine ER: Number of Patients Discontinuing Medication Due to Side Effects | Trial comparisons |
| Amlodipine vs Nifedipine ER: Number of Patients Requiring Hospital Readmission | Trial comparisons |
| Amlodipine vs Nifedipine ER: Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | Trial comparisons |
| Amlodipine vs Nifedipine ER: Breastfeeding Duration of 6+ Weeks | Trial comparisons |
| Amlodipine vs Nifedipine ER: deaths from any cause | Trial comparisons |
| Amlodipine vs Nifedipine ER: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04790279
GET https://conductscience.org/api/trials/v1/NCT04790279/registered