Trial Outcomes & Findings for Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period (NCT NCT04236258)

NCT ID: NCT04236258

Last Updated: 2022-11-30

Results Overview

Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 94 participants
• Primary outcome timeframe: up to six weeks postpartum
• Results posted on: 2022-11-30

Participant Flow

We enrolled 94 participants in the study.

We aimed for 90 participants as part of the protocol but ended up oversampling at 94 due to concern over potential drop out.

Participant milestones

Measure	Nifedipine This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Overall Study STARTED	47	47
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

Baseline characteristics by cohort

Measure	Nifedipine n=47 Participants Participants in the nifedipine group were assigned nifedipine ER 30mg daily as their initial antihypertensive.	Enalapril n=47 Participants Participants in the nifedipine group were assigned enalapril 10mg daily as their initial antihypertensive.	Total n=94 Participants Total of all reporting groups
Age, Continuous	33.3 years STANDARD_DEVIATION 6.3 • n=5 Participants	32.4 years STANDARD_DEVIATION 6.7 • n=7 Participants	32.8 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	47 participants n=7 Participants	94 participants n=5 Participants
Insurance Public insurance	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Insurance Private insurance	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Parity	1.89 para STANDARD_DEVIATION 1.6 • n=5 Participants	1.85 para STANDARD_DEVIATION 1.7 • n=7 Participants	1.87 para STANDARD_DEVIATION 1.7 • n=5 Participants
Twin gestation	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Delivery type Vaginal	12 Participants n=5 Participants	21 Participants n=7 Participants	33 Participants n=5 Participants
Delivery type Operative	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Delivery type Cesarean	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Gestational age at delivery	36.6 weeks STANDARD_DEVIATION 2.3 • n=5 Participants	37.4 weeks STANDARD_DEVIATION 2.9 • n=7 Participants	36.9 weeks STANDARD_DEVIATION 2.6 • n=5 Participants
Hypertensive diagnosis Chronic	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Hypertensive diagnosis Gestational	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Hypertensive diagnosis Preeclampsia without severe features	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Hypertensive diagnosis Preeclampsia with severe features	21 Participants n=5 Participants	30 Participants n=7 Participants	51 Participants n=5 Participants
Hypertensive diagnosis Superimposed preeclampsia	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
BMI	34.6 kg/m^2 STANDARD_DEVIATION 8.0 • n=5 Participants	35.2 kg/m^2 STANDARD_DEVIATION 7.0 • n=7 Participants	34.9 kg/m^2 STANDARD_DEVIATION 7.5 • n=5 Participants

PRIMARY outcome

Timeframe: up to six weeks postpartum

Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Prolonged Hospitalization	13 Participants	17 Participants

PRIMARY outcome

Timeframe: up to six weeks postpartum

Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Unscheduled Clinic Appointment	19 Participants	17 Participants

PRIMARY outcome

Timeframe: up to six weeks postpartum

Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Visit to Labor and Delivery Triage for Evaluation	13 Participants	17 Participants

PRIMARY outcome

Timeframe: up to six weeks postpartum

Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Postpartum Readmission	3 Participants	4 Participants

SECONDARY outcome

Timeframe: up to six weeks postpartum

Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Time to Blood Pressure Control	0.7 days Standard Deviation 1.0	1.9 days Standard Deviation 3.5

SECONDARY outcome

Timeframe: up to six weeks postpartum

Any time a patient needs a second or third agent added to her antihypertensive regimen

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Number of Participants Who Needed for Additional Antihypertensives	6 Participants	16 Participants

SECONDARY outcome

Timeframe: up to six weeks postpartum

The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Time to Discharge	3.2 days Standard Deviation 1.6	3.3 days Standard Deviation 1.7

SECONDARY outcome

Timeframe: up to six weeks postpartum

Any time a patient became symptomatic from her blood pressure as noted by her providers

Outcome measures

Measure	Nifedipine n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=47 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Clinically Significant Hypotension or Hypertension	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-2 weeks

Population: This is the population of participants who attended a 1-2 week clinic visit after discharge and had a creatinine level drawn

Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)

Outcome measures

Measure	Nifedipine n=27 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=21 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Creatinine Values at 1-2 Weeks After Discharge	0.68 mg/dL Standard Deviation 0.11	0.75 mg/dL Standard Deviation 0.17

SECONDARY outcome

Timeframe: up to six weeks postpartum

If a patient still needs the prescribed antihypertensives one week after discharge and six weeks after delivery to control her blood pressure as determined by her provider during her clinic visit

Outcome measures

Measure	Nifedipine n=42 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=40 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Continued Need for Antihypertensive	41 Participants	36 Participants

SECONDARY outcome

Timeframe: up to six weeks postpartum

A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication

Outcome measures

Measure	Nifedipine n=13 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=13 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to six weeks postpartum

The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives ("difficulty remembering to take the medication")

Outcome measures

Measure	Nifedipine n=13 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=13 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Patient Self-reported Compliance With Their Antihypertensive Regimen	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 weeks after delivery

Population: This is the population who attended their 6 week postpartum visit and had a creatinine level drawn at that time

Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)

Outcome measures

Measure	Nifedipine n=12 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.	Enalapril n=13 Participants This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Creatinine Level Around 6 Weeks After Delivery	0.82 mg/dL Standard Deviation 0.15	0.88 mg/dL Standard Deviation 0.14

Adverse Events

Nifedipine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enalapril

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Yoselevsky

Brigham and Women's Hospital

Phone: 314-413-1254

Email: eyoselevsky@bwh.harvard.edu

Results disclosure agreements

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