Trial Outcomes & Findings for Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension (NCT NCT04790279)

NCT ID: NCT04790279

Last Updated: 2024-10-28

Results Overview

length of stay from delivery until discharge

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 175 participants
• Primary outcome timeframe: Through hospital stay, on average 2-5 days
• Results posted on: 2024-10-28

Participant Flow

Patients were randomized at the time of enrollment. Only patients meeting pre-defined criteria were started on an anti-hypertensive.

Participant milestones

Measure	Amlodipine Amlodipine: Initiation of amlodipine 2.5 mg	Nifedipine ER NIFEdipine ER: Initiation of nifedipine ER 30 mg
Overall Study STARTED	87	88
Overall Study COMPLETED	51	69
Overall Study NOT COMPLETED	36	19

Reasons for withdrawal

Measure	Amlodipine Amlodipine: Initiation of amlodipine 2.5 mg	Nifedipine ER NIFEdipine ER: Initiation of nifedipine ER 30 mg
Overall Study Did not meet medication start criteria	27	15
Overall Study Required long acting antihypertensive intrapartum	1	0
Overall Study Protocol Violation	8	3
Overall Study Developed complication requiring alternative regimen	0	1

Baseline Characteristics

Data were not collected

Baseline characteristics by cohort

Measure	Amlodipine n=87 Participants Patients randomized to amlodipine	Nifedipine ER n=88 Participants Patients randomized to nifedipine ER	Total n=175 Participants Total of all reporting groups
Age, Continuous	27.9 years STANDARD_DEVIATION 6.8 • n=87 Participants	27.8 years STANDARD_DEVIATION 5.9 • n=88 Participants	27.8 years STANDARD_DEVIATION 6.3 • n=175 Participants
Sex: Female, Male Female	0 Participants Data were not collected	0 Participants Data were not collected	0 Participants Data were not collected
Sex: Female, Male Male	0 Participants Data were not collected	0 Participants Data were not collected	0 Participants Data were not collected
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	87 Participants n=87 Participants	88 Participants n=88 Participants	175 Participants n=175 Participants
BMI at delivery	36.8 kg/m2 STANDARD_DEVIATION 9.3 • n=87 Participants	37.0 kg/m2 STANDARD_DEVIATION 10.1 • n=88 Participants	36.9 kg/m2 STANDARD_DEVIATION 9.7 • n=175 Participants
Parity	1 number of deliveries n=87 Participants	1 number of deliveries n=88 Participants	1 number of deliveries n=175 Participants
Gestational age at delivery	35.7 weeks STANDARD_DEVIATION 2.5 • n=87 Participants	35.6 weeks STANDARD_DEVIATION 3.3 • n=88 Participants	35.6 weeks STANDARD_DEVIATION 2.9 • n=175 Participants
Mode of delivery Vaginal	40 participants n=87 Participants	44 participants n=88 Participants	84 participants n=175 Participants
Mode of delivery Cesarean	47 participants n=87 Participants	44 participants n=88 Participants	91 participants n=175 Participants
Hypertensive diagnosis Chronic hypertension	21 participants n=87 Participants	22 participants n=88 Participants	43 participants n=175 Participants
Hypertensive diagnosis Preeclampsia without severe features	3 participants n=87 Participants	3 participants n=88 Participants	6 participants n=175 Participants
Hypertensive diagnosis Preeclampsia with severe features	84 participants n=87 Participants	81 participants n=88 Participants	165 participants n=175 Participants
Diabetes None	71 Participants n=87 Participants	66 Participants n=88 Participants	137 Participants n=175 Participants
Diabetes Gestational	8 Participants n=87 Participants	15 Participants n=88 Participants	23 Participants n=175 Participants
Diabetes Pre-gestational	8 Participants n=87 Participants	7 Participants n=88 Participants	15 Participants n=175 Participants

PRIMARY outcome

Timeframe: Through hospital stay, on average 2-5 days

Population: Amlodipine Intent To Treat

length of stay from delivery until discharge

Outcome measures

Measure	Amlodipine n=87 Participants Amlodipine Intent to Treat	Nifedipine ER n=88 Participants Nifedipine ER Intent To Treat
Length of Stay	73.5 hours Interval 67.0 to 81.0	72.0 hours Interval 66.5 to 78.5

SECONDARY outcome

Timeframe: Through hospital stay, on average 2-5 days

Population: Patients who received at least 1 dose of assigned study medication at correct starting dose

Outcome measures

Measure	Amlodipine n=51 Participants Amlodipine Intent to Treat	Nifedipine ER n=69 Participants Nifedipine ER Intent To Treat
Number of Acute Treatments After Medication Initiation	4.0 number acute treatments Standard Deviation 2.7	1.5 number acute treatments Standard Deviation 1.5

SECONDARY outcome

Timeframe: Through hospital stay, on average 2-5 days

Population: Patients receiving at least 1 dose of assigned study medication at correct starting dose

Side effects based on patient reported survey where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always

Outcome measures

Measure	Amlodipine n=51 Participants Amlodipine Intent to Treat	Nifedipine ER n=69 Participants Nifedipine ER Intent To Treat
Patient Reported Side Effects Flushing	1.33 score on a scale Standard Deviation 0.72	1.60 score on a scale Standard Deviation 1.00
Patient Reported Side Effects Swelling	1.55 score on a scale Standard Deviation 1.16	1.71 score on a scale Standard Deviation 1.09
Patient Reported Side Effects Headaches	1.71 score on a scale Standard Deviation 1.06	1.98 score on a scale Standard Deviation 1.17
Patient Reported Side Effects Other	1.24 score on a scale Standard Deviation 0.85	1.11 score on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Through hospital stay, on average 2-5 days

Outcome measures

Measure	Amlodipine n=51 Participants Amlodipine Intent to Treat	Nifedipine ER n=69 Participants Nifedipine ER Intent To Treat
Number of Patients Discontinuing Medication Due to Side Effects	0 Participants	7 Participants

SECONDARY outcome

Timeframe: until 6 weeks postpartum

Outcome measures

Measure	Amlodipine n=51 Participants Amlodipine Intent to Treat	Nifedipine ER n=69 Participants Nifedipine ER Intent To Treat
Number of Patients Requiring Hospital Readmission	3 Participants	3 Participants

SECONDARY outcome

Timeframe: until 6 weeks postpartum

Population: Only includes patients who answered relevant question on breastfeeding questionnaire

Outcome measures

Measure	Amlodipine n=12 Participants Amlodipine Intent to Treat	Nifedipine ER n=17 Participants Nifedipine ER Intent To Treat
Breastfeeding Duration of 6+ Weeks	4 Participants	3 Participants

SECONDARY outcome

Timeframe: until 6 weeks postpartum

Population: Only includes patients who answered relevant question on breastfeeding questionnaire

Outcome measures

Measure	Amlodipine n=27 Participants Amlodipine Intent to Treat	Nifedipine ER n=36 Participants Nifedipine ER Intent To Treat
Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire	22 Participants	32 Participants

Adverse Events

Amlodipine

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Nifedipine ER

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Amlodipine n=53 participants at risk Amlodipine: Initiation of amlodipine 2.5 mg	Nifedipine ER n=69 participants at risk NIFEdipine ER: Initiation of nifedipine ER 30 mg
Pregnancy, puerperium and perinatal conditions Readmission	5.7% 3/53 • Number of events 3 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included	4.3% 3/69 • Number of events 3 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included
Pregnancy, puerperium and perinatal conditions Prolonged hospitalization	1.9% 1/53 • Number of events 1 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included	1.4% 1/69 • Number of events 1 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included

Other adverse events

Measure	Amlodipine n=53 participants at risk Amlodipine: Initiation of amlodipine 2.5 mg	Nifedipine ER n=69 participants at risk NIFEdipine ER: Initiation of nifedipine ER 30 mg
Pregnancy, puerperium and perinatal conditions Prolonged hospitalization	26.4% 14/53 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included	15.9% 11/69 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included
Pregnancy, puerperium and perinatal conditions Side effect requiring discontinuation	0.00% 0/53 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included	10.1% 7/69 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included
Pregnancy, puerperium and perinatal conditions Triage/ER visit	9.4% 5/53 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included	13.0% 9/69 • Through 6 weeks postpartum Only patients receiving at least one dose of assigned study medication are included

Additional Information

Katelyn Pratt

Prisma Health Upstate

Phone: 2176223524

Email: katelyn.pratt@prismahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place