CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Acetaminophen +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • Diagnosis of severe hypertensive disorder of pregnancy: preeclampsia with severe features, HELLP syndrome, eclampsia, or chronic hypertension with superimposed preeclampsia with severe features
  • Not yet delivered or less than 6 hours after delivery at enrollment
  • Ability to give informed consent
Key exclusion· 6
  • Serum creatinine >1.0 mg/dL or suspicion of acute kidney injury
  • AST >200 unit/L or ALT >200 unit/L
  • Known allergy or sensitivity to NSAIDs or acetaminophen
  • Chronic kidney disease, chronic liver disease, prior liver transplant, or chronic infectious hepatitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02911701
NCT02911701Phase 4Completed

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

University of New Mexico·interventional·Posted Sep 22, 2016·Updated Jul 27, 2023

In Brief

A Phase 4 clinical trial evaluating Acetaminophen and Ibuprofen for Pre-Eclampsia and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 22, 2016
Enrollment StartSep 1, 2016
Primary CompletionNov 7, 2017
Study CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.8 years ago

Interventions

Acetaminophendrug

Ibuprofendrug