Phase 4
N=175
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
Hypertension in Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT04790279 ↗Enrolled (actual)
175
Serious AEs
6.6%
Results posted
Oct 2024
Primary outcome: Primary: Length of Stay — 73.5; 72.0 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amlodipine (Drug); NIFEdipine ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Prisma Health-Upstate
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay |
73.5; 72.0 | — |
| SECONDARY Number of Acute Treatments After Medication Initiation |
4.0; 1.5 | — |
| SECONDARY Patient Reported Side Effects |
1.33; 1.60; 1.55; 1.71; 1.71; 1.98 | — |
| SECONDARY Number of Patients Discontinuing Medication Due to Side Effects |
0; 7 | — |
| SECONDARY Number of Patients Requiring Hospital Readmission |
3; 3 | — |
| SECONDARY Breastfeeding Duration of 6+ Weeks |
4; 3 | — |
| SECONDARY Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire |
22; 32 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04790279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.