Phase 4
N=100
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
Pre-Eclampsia · HELLP Syndrome · Eclampsia
Bottom Line
View on ClinicalTrials.gov: NCT02911701 ↗Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Jul 2023
Primary outcome: Primary: Duration of Severe-range Hypertension After Delivery — 38.0; 35.3 hours — p=0.3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Ibuprofen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe-range Hypertension After Delivery |
38.0; 35.3 | 0.3 |
| SECONDARY Length of Hospitalization |
4.0; 3.8 | — |
| SECONDARY Mean Arterial Pressure Over the Entire Postpartum Hospitalization |
97.3; 37.6 | — |
| SECONDARY Mean Arterial Pressure, Stratified by Postpartum Day 1, 2, 3, Etc. |
— | — |
| SECONDARY Mean Total Number of Severe Range Blood Pressure Measurements in Each Study Arm. |
— | — |
| SECONDARY Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs |
31; 34 | — |
| SECONDARY Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg) |
165; 168 | — |
| SECONDARY Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge |
31; 33 | — |
| SECONDARY Number of Scheduled Oral Antihypertensive Agents Required at Discharge |
— | — |
| SECONDARY Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure |
26; 30 | — |
| SECONDARY The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives |
26; 30 | — |
| SECONDARY Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day |
2.4; 1.8 | — |
| SECONDARY Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day |
22.6; 22.1; 32.3; 27.5; 45.4; 28.9 | — |
| SECONDARY Serum Creatinine Trend From Day of Delivery to Day of Discharge |
— | — |
| SECONDARY Mean Drop in Hematocrit From Pre-delivery to the Nadir Prior to Discharge |
— | — |
| SECONDARY Composite of Adverse Events |
0; 0 | — |
| SECONDARY Proportion of Study Participants in Each Study Arm With New Onset Postpartum Elevation of Liver Function Tests (AST, ALT) Above Twice the Normal Limit |
1; 0 | — |
| SECONDARY Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury |
0; 0 | — |
| SECONDARY Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage |
0; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02911701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.