Overview

Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
Female
Summary
NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. This study aims to assess the effect of avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with preeclampsia with severe features. Eligible women will be randomized to receive either acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies for pain control although ibuprofen has better pain control than acetaminophen. The primary outcome will be duration of postpartum severe-range hypertension.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of New Mexico
Treatments:
Acetaminophen
Ibuprofen
Criteria
Inclusion Criteria:

- ability to give informed consent

- diagnosis of a "severe" hypertensive disorder of pregnancy:

- preeclampsia with severe features

- chronic hypertension with superimposed preeclampsia with severe features

- HELLP syndrome: hemolysis, elevated liver function tests, low platelets

- eclampsia

- not yet delivered or less than 6 hours after delivery

Exclusion Criteria:

- current incarceration

- serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury

- AST (aspartate aminotransferase) >200 unit/L

- ALT (alanine aminotransferase) > 200 unit/L

- known allergy or sensitivity to NSAIDs or acetaminophen

- delivery > 6 hours prior to enrollment

- chronic kidney disease

- chronic liver disease

- prior liver transplant

- chronic infectious hepatitis

- gastritis

- gastro-esophageal reflux disease (GERD)

- peptic ulcer disease

- bleeding disorder

- provider feels that participation is not in the best interest of the patient