Hypertension, Pregnancy-Induced Clinical Trial
— HIPPSOfficial title:
A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
NCT number | NCT03011567 |
Other study ID # | 663-15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | October 2019 |
Verified date | August 2020 |
Source | MemorialCare Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs) administered during the postpartum period influence blood pressure in women with hypertensive disorders of pregnancy. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.
Status | Completed |
Enrollment | 202 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Delivery occurred at equal to or greater than 24 0/7 weeks gestational age - Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services - Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following: - Gestational hypertension - Preeclampsia without severe features - Preeclampsia with severe features - Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome - Eclampsia Exclusion Criteria: - Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age. - Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization - Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy) - Low platelet count (recorded measurement <50,000 during hospital admission) - Significant liver dysfunction (AST or ALT >500) - Known sensitivities to ibuprofen or acetaminophen - Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable) - Postpartum hemorrhage requiring transfusion |
Country | Name | City | State |
---|---|---|---|
United States | Miller Children and Women Hospital Long Beach | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
MemorialCare Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Mean Arterial Blood Pressure- Mild Group | Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group | Averaged from all blood pressures measured through study completion, an average of 3 days | |
Primary | Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group | Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization | Through study completion, an average of 3 days | |
Secondary | Pain Control During Hospital Stay | Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay Minimum 0, maximum 10. 10 means the highest level of pain | Through study completion, an average of 3 days | |
Secondary | Outpatient Blood Pressure Measurement | Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge | 6 weeks after discharge from the hospital | |
Secondary | Patient Satisfaction | Number of patients reporting "High level of satisfaction with pain medications" | Through study completion, an average of 3 days | |
Secondary | Length of Hospital Stay | Length of Hospital Stay after delivery | Through study completion, an average of 3 days | |
Secondary | Diuresis | Achievement of average 200ml/hour for 4 consecutive hours | Through study completion, an average of 3 days | |
Secondary | Average Mean Arterial Blood Pressures During Hospital Stay | Averaged from all blood pressures measured through study completion, an average of 3 days |
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