CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 74 enrolled
Drug / intervention
Ibuprofen +1 moredrug
Likely dose
Ibuprofen (dose not specified) followed by acetaminophen; or acetaminophen followed by ibuprofen for postpartum analgesiaAI-extracted
Key inclusion· 4
  • Antepartum women with diagnosis of Gestational Hypertension or Pre-eclampsia confirmed by blood pressure ≥140 systolic or ≥90 diastolic on at least 2 measurements ≥4 hours apart; with or without proteinuria
  • Taking 1 or fewer oral medications for blood pressure control
  • Singleton gestation
  • English-speaking
Key exclusion· 11
  • Allergy to nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen
  • More than 1 severe range blood pressure (≥160 systolic or ≥110 diastolic) prior to enrollment
  • Neurologic symptoms attributed to hypertension (headache, visual changes) prior to enrollment
  • Pulmonary edema

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

Search/NCT02891174
NCT02891174Phase 4Completed

A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

University of Michigan·interventional·Posted Sep 7, 2016·Updated May 23, 2019

In Brief

A Phase 4 clinical trial evaluating Ibuprofen and Acetaminophen for Hypertension, Pregnancy-Induced and Pre-eclampsia. Completed, enrolled 74 participants across 1 site.

Detailed Summary

To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).

Study Details

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

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2016
Enrollment StartDec 1, 2016
Primary CompletionMar 31, 2018
Study CompletionJun 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.8 years ago

Interventions

Ibuprofendrug

At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.

Acetaminophendrug

At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen.