Clinical trial NCT04236258: Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Official title: A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Preeclampsia Severe
Gestational Hypertension
Postpartum Preeclampsia
Postpartum
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prolonged Hospitalization
timeFrame: up to six weeks postpartum
measure: Unscheduled Clinic Appointment
timeFrame: up to six weeks postpartum
measure: Visit to Labor and Delivery Triage for Evaluation
timeFrame: up to six weeks postpartum
measure: Postpartum Readmission
timeFrame: up to six weeks postpartum
Secondary outcomes:
measure: Time to Blood Pressure Control
timeFrame: up to six weeks postpartum
measure: Number of Participants Who Needed for Additional Antihypertensives
timeFrame: up to six weeks postpartum
measure: Time to Discharge
timeFrame: up to six weeks postpartum
measure: Clinically Significant Hypotension or Hypertension
timeFrame: up to six weeks postpartum
measure: Creatinine Values at 1-2 Weeks After Discharge
timeFrame: 1-2 weeks
measure: Continued Need for Antihypertensive
timeFrame: up to six weeks postpartum
measure: Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
timeFrame: up to six weeks postpartum
measure: Patient Self-reported Compliance With Their Antihypertensive Regimen
timeFrame: up to six weeks postpartum
measure: Creatinine Level Around 6 Weeks After Delivery
timeFrame: 6 weeks after delivery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Thomas McElrath, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: