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.
Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the potential for increased blood pressure in patients with chronic hypertensive disorders receiving these agents. Notably, these studies were conducted on patients with longstanding chronic hypertension, which included males and non-pregnant females, and it is therefore unclear whether this recommendation is appropriate for patients with transient hypertensive disorders of pregnancy. This protocol describes a randomized trial to evaluate whether NSAIDs influence blood pressure parameters in patients with hypertensive disorders of pregnancy. Patients with severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women with mild hypertensive disorders of pregnancy (Mild HDP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
Participants will receive acetaminophen for postpartum mild pain relief
Participants will receive ibuprofen for postpartum mild pain relief
Miller Children and Women Hospital Long Beach
Long Beach, California, United States
Average Mean Arterial Blood Pressure- Mild Group
Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Time frame: Averaged from all blood pressures measured through study completion, an average of 3 days
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
Time frame: Through study completion, an average of 3 days
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
Time frame: Through study completion, an average of 3 days
Outpatient Blood Pressure Measurement
Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge
Time frame: 6 weeks after discharge from the hospital
Patient Satisfaction
Number of patients reporting "High level of satisfaction with pain medications"
Time frame: Through study completion, an average of 3 days
Length of Hospital Stay
Length of Hospital Stay after delivery
Time frame: Through study completion, an average of 3 days
Diuresis
Achievement of average 200ml/hour for 4 consecutive hours
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Time frame: Through study completion, an average of 3 days
Average Mean Arterial Blood Pressures During Hospital Stay
Time frame: Averaged from all blood pressures measured through study completion, an average of 3 days