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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04236258
Other study ID # 2019P002981
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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