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

November 10, 2022 updated by: Thomas Frederick McElrath, M.D.,Ph.D., Brigham and Women's Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
Active Comparator: 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.
Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged Hospitalization
Time Frame: up to six weeks postpartum
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
up to six weeks postpartum
Unscheduled Clinic Appointment
Time Frame: 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
up to six weeks postpartum
Visit to Labor and Delivery Triage for Evaluation
Time Frame: 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
up to six weeks postpartum
Postpartum Readmission
Time Frame: up to six weeks postpartum
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
up to six weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Blood Pressure Control
Time Frame: up to six weeks postpartum
Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)
up to six weeks postpartum
Number of Participants Who Needed for Additional Antihypertensives
Time Frame: up to six weeks postpartum
Any time a patient needs a second or third agent added to her antihypertensive regimen
up to six weeks postpartum
Time to Discharge
Time Frame: up to six weeks postpartum
The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension
up to six weeks postpartum
Clinically Significant Hypotension or Hypertension
Time Frame: up to six weeks postpartum
Any time a patient became symptomatic from her blood pressure as noted by her providers
up to six weeks postpartum
Creatinine Values at 1-2 Weeks After Discharge
Time Frame: 1-2 weeks
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
Continued Need for Antihypertensive
Time Frame: 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
up to six weeks postpartum
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
Time Frame: up to six weeks postpartum
A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication
up to six weeks postpartum
Patient Self-reported Compliance With Their Antihypertensive Regimen
Time Frame: 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")
up to six weeks postpartum
Creatinine Level Around 6 Weeks After Delivery
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas McElrath, MD, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.

IPD Sharing Time Frame

The data will be available for approximately six months after the study's conclusion.

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal Institutional Review Board.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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