Hypertension in Pregnancy Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Verified date | November 2022 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00974714 -
L-arginine Effects on Chronic Hypertension in Pregnancy
|
Phase 3 | |
Terminated |
NCT03595982 -
Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
|
Phase 4 | |
Completed |
NCT04486170 -
Assessment of Postpartum Education to Improve Compliance
|
N/A | |
Completed |
NCT03506724 -
Response to Anti-hypertensives in Pregnant and Postpartum Patients
|
Phase 4 | |
Completed |
NCT03613714 -
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
|
N/A | |
Recruiting |
NCT04604535 -
The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy
|
N/A | |
Completed |
NCT00412230 -
Insulin Resistance and Hypertensive Disorders in Pregnancy
|
N/A | |
Active, not recruiting |
NCT05049616 -
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
|
Phase 4 | |
Completed |
NCT04119232 -
Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy
|
N/A | |
Completed |
NCT04633551 -
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
|
N/A | |
Completed |
NCT05859282 -
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension
|
||
Active, not recruiting |
NCT05543265 -
Bridging the Gap From Postpartum to Primary Care
|
N/A | |
Completed |
NCT00571766 -
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy
|
Phase 3 | |
Recruiting |
NCT05473767 -
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
|
N/A | |
Recruiting |
NCT05683093 -
Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
|
||
Completed |
NCT06403722 -
Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio
|
||
Recruiting |
NCT05852054 -
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
|
Phase 3 | |
Recruiting |
NCT05137808 -
Understanding Blood Pressure Changes After Birth
|
||
Completed |
NCT03961360 -
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03648645 -
Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
|
N/A |