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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension in Pregnancy Preeclampsia Severe Gestational Hypertension Postpartum Preeclampsia Postpartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

NIFEdipine ER

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.

Interventions

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NIFEdipine ER

Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.

Intervention Type DRUG

Enalapril

Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes