Hypertension In Postpartum Preeclampsia Study

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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).

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Severe HDP- NSAID	Ibuprofen	This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Mild HDP- NSAID	Ibuprofen	This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Severe HDP- No NSAID	Acetaminophen	This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Mild HDP- No NSAID	Acetaminophen	This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Primary Outcome Measures

Name	Time	Method
Average Mean Arterial Blood Pressure- Mild Group	Averaged from all blood pressures measured through study completion, an average of 3 days	Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group	Through study completion, an average of 3 days	Proportion of participants with at least one episode of severe blood pressure postpartum (systolic \>=160 or diastolic \>=105mmHg) during inpatient postpartum hospitalization

Secondary Outcome Measures

Name	Time	Method
Average Mean Arterial Blood Pressures During Hospital Stay	Averaged from all blood pressures measured through study completion, an average of 3 days
Pain Control During Hospital Stay	Through study completion, an average of 3 days	Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay Minimum 0, maximum 10. 10 means the highest level of pain
Outpatient Blood Pressure Measurement	6 weeks after discharge from the hospital	Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge
Patient Satisfaction	Through study completion, an average of 3 days	Number of patients reporting "High level of satisfaction with pain medications"
Length of Hospital Stay	Through study completion, an average of 3 days	Length of Hospital Stay after delivery
Diuresis	Through study completion, an average of 3 days	Achievement of average 200ml/hour for 4 consecutive hours