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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Preeclampsia Severe; Gestational Hypertension; Postpartum; Postpartum Preeclampsia; Hypertension in Pregnancy

Treatments: Drug: Enalapril; Drug: NIFEdipine ER

Study type: Interventional

Funder types: Other

Identifiers

NCT04236258

2019P002981

Details and patient eligibility

About

This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.

Full description

This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.

Nifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period.

Enrollment: 94 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
• provider wanting to initiate antihypertensive in the postpartum period
• the patient is not currently on >1 antihypertensive
• plans to receive postpartum care at the hospital or affiliated clinic

Exclusion criteria

• sustained pulse <60 or >120 BPM over four hours
• allergy to any of the antihypertensives
• creatinine greater than or equal to 1.5
• strict contraindication to any of the antihypertensives
• history of failed treatment with any of the antihypertensives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Nifedipine

Active Comparator group

Description:

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.

Treatment:

Drug: NIFEdipine ER

Enalapril

Active Comparator group

Description:

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.

Treatment:

Drug: Enalapril