drugset / Trial / NCT02911701

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

NCT02911701 ↗

Phase 4 Completed 100 enrolled University of New Mexico
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-09
Primary completion
2017-11-07
Completion
2018-01-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Acetaminophen vs Ibuprofen; p = 0.3; maxim NCT02911701 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 650 mg Oral
Comparator Ibuprofen Small molecule 600 mg Oral