Hypertension in Pregnancy
Conditions
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.
Interventions
DRUGAmlodipine
Initiation of amlodipine 2.5 mg
DRUGNIFEdipine ER
Initiation of nifedipine ER 30 mg
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Through hospital stay, on average 2-5 days | length of stay from delivery until discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Acute Treatments After Medication Initiation | Through hospital stay, on average 2-5 days | — |
| 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 |
| Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | until 6 weeks postpartum | — |
| Number of Patients Requiring Hospital Readmission | until 6 weeks postpartum | — |
| Breastfeeding Duration of 6+ Weeks | until 6 weeks postpartum | — |
| Number of Patients Discontinuing Medication Due to Side Effects | Through hospital stay, on average 2-5 days | — |
Countries
United States
Participant flow
Pre-assignment details
Patients were randomized at the time of enrollment. Only patients meeting pre-defined criteria were started on an anti-hypertensive.
Participants by arm
| Arm | Count |
|---|---|
| Amlodipine Patients randomized to amlodipine | 87 |
| Nifedipine ER Patients randomized to nifedipine ER | 88 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Developed complication requiring alternative regimen | 0 | 1 |
| Overall Study | Did not meet medication start criteria | 27 | 15 |
| Overall Study | Protocol Violation | 8 | 3 |
| Overall Study | Required long acting antihypertensive intrapartum | 1 | 0 |
Baseline characteristics
| Characteristic | Nifedipine ER | Total | Amlodipine |
|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 5.9 | 27.8 years STANDARD_DEVIATION 6.3 | 27.9 years STANDARD_DEVIATION 6.8 |
| BMI at delivery | 37.0 kg/m2 STANDARD_DEVIATION 10.1 | 36.9 kg/m2 STANDARD_DEVIATION 9.7 | 36.8 kg/m2 STANDARD_DEVIATION 9.3 |
| Diabetes Gestational | 15 Participants | 23 Participants | 8 Participants |
| Diabetes None | 66 Participants | 137 Participants | 71 Participants |
| Diabetes Pre-gestational | 7 Participants | 15 Participants | 8 Participants |
| Gestational age at delivery | 35.6 weeks STANDARD_DEVIATION 3.3 | 35.6 weeks STANDARD_DEVIATION 2.9 | 35.7 weeks STANDARD_DEVIATION 2.5 |
| Hypertensive diagnosis Chronic hypertension | 22 participants | 43 participants | 21 participants |
| Hypertensive diagnosis Preeclampsia without severe features | 3 participants | 6 participants | 3 participants |
| Hypertensive diagnosis Preeclampsia with severe features | 81 participants | 165 participants | 84 participants |
| Mode of delivery Cesarean | 44 participants | 91 participants | 47 participants |
| Mode of delivery Vaginal | 44 participants | 84 participants | 40 participants |
| Parity | 1 number of deliveries | 1 number of deliveries | 1 number of deliveries |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 88 Participants | 175 Participants | 87 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 69 |
| other Total, other adverse events | 19 / 53 | 26 / 69 |
| serious Total, serious adverse events | 4 / 53 | 4 / 69 |
Outcome results
Primary
Length of Stay
length of stay from delivery until discharge
Time frame: Through hospital stay, on average 2-5 days
Population: Amlodipine Intent To Treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amlodipine | Length of Stay | 73.5 hours |
| Nifedipine ER | Length of Stay | 72.0 hours |
Secondary
Breastfeeding Duration of 6+ Weeks
Time frame: until 6 weeks postpartum
Population: Only includes patients who answered relevant question on breastfeeding questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amlodipine | Breastfeeding Duration of 6+ Weeks | 4 Participants |
| Nifedipine ER | Breastfeeding Duration of 6+ Weeks | 3 Participants |
Secondary
Number of Acute Treatments After Medication Initiation
Time frame: Through hospital stay, on average 2-5 days
Population: Patients who received at least 1 dose of assigned study medication at correct starting dose
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Amlodipine | Number of Acute Treatments After Medication Initiation | 4.0 number acute treatments | Standard Deviation 2.7 |
| Nifedipine ER | Number of Acute Treatments After Medication Initiation | 1.5 number acute treatments | Standard Deviation 1.5 |
Secondary
Number of Patients Discontinuing Medication Due to Side Effects
Time frame: Through hospital stay, on average 2-5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amlodipine | Number of Patients Discontinuing Medication Due to Side Effects | 0 Participants |
| Nifedipine ER | Number of Patients Discontinuing Medication Due to Side Effects | 7 Participants |
Secondary
Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire
Time frame: until 6 weeks postpartum
Population: Only includes patients who answered relevant question on breastfeeding questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amlodipine | Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | 22 Participants |
| Nifedipine ER | Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire | 32 Participants |
Secondary
Number of Patients Requiring Hospital Readmission
Time frame: until 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amlodipine | Number of Patients Requiring Hospital Readmission | 3 Participants |
| Nifedipine ER | Number of Patients Requiring Hospital Readmission | 3 Participants |
Secondary
Patient Reported Side Effects
Side effects based on patient reported survey where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always
Time frame: Through hospital stay, on average 2-5 days
Population: Patients receiving at least 1 dose of assigned study medication at correct starting dose
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | Patient Reported Side Effects | Flushing | 1.33 score on a scale | Standard Deviation 0.72 |
| Amlodipine | Patient Reported Side Effects | Swelling | 1.55 score on a scale | Standard Deviation 1.16 |
| Amlodipine | Patient Reported Side Effects | Headaches | 1.71 score on a scale | Standard Deviation 1.06 |
| Amlodipine | Patient Reported Side Effects | Other | 1.24 score on a scale | Standard Deviation 0.85 |
| Nifedipine ER | Patient Reported Side Effects | Other | 1.11 score on a scale | Standard Deviation 0.55 |
| Nifedipine ER | Patient Reported Side Effects | Flushing | 1.60 score on a scale | Standard Deviation 1 |
| Nifedipine ER | Patient Reported Side Effects | Headaches | 1.98 score on a scale | Standard Deviation 1.17 |
| Nifedipine ER | Patient Reported Side Effects | Swelling | 1.71 score on a scale | Standard Deviation 1.09 |