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

Hypertension in Pregnancy Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236258
• Other study ID #: 2019P002981
• Status: Completed
• Phase: Phase 4
• Start date: January 24, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Hypertension
• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Postpartum
• Postpartum Preeclampsia
• Pre-Eclampsia
• Preeclampsia Severe

Intervention

Drug:
• NIFEdipine ER
Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Hospitalization	Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery	up to six weeks postpartum
Primary	Unscheduled Clinic Appointment	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	up to six weeks postpartum
Primary	Visit to Labor and Delivery Triage for Evaluation	Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason	up to six weeks postpartum
Primary	Postpartum Readmission	Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period	up to six weeks postpartum
Secondary	Time to Blood Pressure Control	Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)	up to six weeks postpartum
Secondary	Number of Participants Who Needed for Additional Antihypertensives	Any time a patient needs a second or third agent added to her antihypertensive regimen	up to six weeks postpartum
Secondary	Time to Discharge	The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension	up to six weeks postpartum
Secondary	Clinically Significant Hypotension or Hypertension	Any time a patient became symptomatic from her blood pressure as noted by her providers	up to six weeks postpartum
Secondary	Creatinine Values at 1-2 Weeks After Discharge	Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)	1-2 weeks
Secondary	Continued Need for Antihypertensive	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	up to six weeks postpartum
Secondary	Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received	A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication	up to six weeks postpartum
Secondary	Patient Self-reported Compliance With Their Antihypertensive Regimen	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")	up to six weeks postpartum
Secondary	Creatinine Level Around 6 Weeks After Delivery	Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)	6 weeks after delivery