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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911701
• Other study ID #: 16-147
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: January 10, 2018

Study information

• Verified date: July 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The proposed study is a randomized, controlled, double-masked trial comparing the effect of postpartum acetaminophen and ibuprofen on blood pressure among women with preeclampsia. Study participants will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain control. Study participants, study personnel and providers will be blinded to randomization status of study participants. Potential study participants will be enrolled when they are diagnosed with a severe hypertensive disorder of pregnancy. This will usually occur prior to delivery, but may occur up to 6 hours after delivery. Patients diagnosed with preeclampsia without severe features will also be approached and enrolled at the time of diagnosis in anticipation for possible progression to preeclampsia with severe features. Once enrolled, study participants will not be randomized until delivery, at which time they will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain. Both groups will have available oxycodone for moderate to severe pain, per our routine. Study group allocation will only be known by the investigational pharmacy. The ibuprofen and acetaminophen will be made to appear identical to each other and will be unmarked through encapsulation. Block randomization will be used to ensure equal allocation to the two study arms. For the duration of study participation, study participants will undergo postpartum monitoring with vital sign measurements (including blood pressure) every 4 hours, pain assessment with each administration of study medication, as well as daily evaluation of laboratory studies until they have normalized to the satisfaction of their provider. Study participants will receive the study drug every 6 hours from the time of delivery until hospital discharge, unless they refuse. Study participation will be complete upon hospital discharge. Study participants will be contacted by a study team member 6 weeks after delivery to ask about any additional complications or symptoms requiring visits to the emergency department or hospital readmission. Descriptive factors and clinical outcomes will be extracted from the medical record and de-identified by study personnel during each day of study participation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 10, 2018
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• HELLP Syndrome
• Pre-Eclampsia

Intervention

Drug:
• Acetaminophen

• Ibuprofen

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Severe-range Hypertension After Delivery	length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Length of Hospitalization	number of days from delivery until hospital discharge	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Mean Arterial Pressure Over the Entire Postpartum Hospitalization	computed mean arterial pressure using all measured blood pressures during postpartum hospitalization	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Mean Arterial Pressure, Stratified by Postpartum Day 1, 2, 3, Etc.	computed mean arterial pressure using all measured blood pressures during postpartum hospitalization, stratified by postpartum day (1, 2, 3, etc.)	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Mean Total Number of Severe Range Blood Pressure Measurements in Each Study Arm.	mean total number of severe range blood pressure (defined as SBP >160mmGh or DBP >110mmHg) measurements in each study arm	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs	Severe-range hypertension (defined as SBP > 160 mmHg or DBP >1100 mmHg) during postpartum stay	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg)		duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge		duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Number of Scheduled Oral Antihypertensive Agents Required at Discharge		duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure	Proportion in each arm who required one or more doses of antihypertensive medication given for acute lowering of BP	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives	The proportion of study participants in each study arm who require any IV antihypertensives to acutely lower blood pressure during their postpartum hospital stay.	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day	Mean daily pain level, as reported by patient on scale from 1-10 (10 is most severe).	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day		duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Serum Creatinine Trend From Day of Delivery to Day of Discharge		duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Mean Drop in Hematocrit From Pre-delivery to the Nadir Prior to Discharge	Mean difference in hematocrit from pre-delivery to postpartum nadir prior to discharge	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Composite of Adverse Events	Adverse events include seizure, stroke, posterior reversible encephalopathy syndrome, repeat course of IV magnesium sulfate for seizure prophylaxis.	duration of postpartum hospitalization (approximately 3-7 days)
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	AST: Aspartate aminotransferase; ALT: alanine aminotransferase	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury	Acute kidney injury is defined as serum creatinine > 1.1mg/dL or double the baseline value	duration of postpartum hospitalization (approximately 3-7 days)
Secondary	Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage	Delayed postpartum hemorrhage is defined as > 1000 mL of blood loss occuring > 24 hours after delivery	duration of postpartum hospitalization (approximately 3-7 days)