Hypertension In Postpartum Preeclampsia Study (HIPPS)

MemorialCare Health System

Status: Completed

Conditions: Hypertension, Pregnancy-Induced

Treatments: Drug: Acetaminophen; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT03011567

663-15

Details and patient eligibility

About

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.

Full 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).

Enrollment: 202 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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202 participants in 4 patient groups

Severe HDP- NSAID

Experimental group

Description:

This arm will be assigned a postpartum analgesic regimen with ibuprofen.

Treatment:

Drug: Ibuprofen

Mild HDP- NSAID

Experimental group

Description:

This arm will be assigned a postpartum analgesic regimen with ibuprofen.

Treatment:

Drug: Ibuprofen

Severe HDP- No NSAID

Experimental group

Description:

This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Treatment:

Drug: Acetaminophen

Mild HDP- No NSAID

Experimental group

Description:

This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Treatment:

Drug: Acetaminophen