Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 148 for:    severe preeclampsia AND hypertensive disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02911701
Recruitment Status : Unknown
Verified October 2017 by Luis Izquierdo, University of New Mexico.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Izquierdo, University of New Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia HELLP Syndrome Eclampsia Drug: Acetaminophen Drug: Ibuprofen Phase 4

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
Study Start Date : September 2016
Estimated Primary Completion Date : December 18, 2017
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: Acetaminophen
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Drug: Acetaminophen
Other Name: Tylenol

Active Comparator: Ibuprofen
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Drug: Ibuprofen
Other Name: Motrin




Primary Outcome Measures :
  1. Duration of severe-range hypertension after delivery [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured


Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    number of days from delivery until hospital discharge

  2. Mean arterial pressure over the entire postpartum hospitalization [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    computed mean arterial pressure using all measured blood pressures during postpartum hospitalization

  3. Mean arterial pressure, stratified by postpartum day 1, 2, 3, etc. [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    computed mean arterial pressure using all measured blood pressures during postpartum hospitalization, stratified by postpartum day (1, 2, 3, etc.)

  4. mean total number of severe range blood pressure measurements in each study arm. [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  5. Proportion of study participants in each study arm who have any severe range [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    hypertension during postpartum stay

  6. Mean maximum measured blood pressure for entire postpartum hospitalization (in mm Hg) [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  7. Proportion of study participants requiring the use of scheduled oral antihypertensives at discharge [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  8. Number of scheduled oral antihypertensive agents required at discharge [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  9. Number of doses of antihypertensives (either oral or intravenous) given for acute lowering of blood pressure [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  10. The proportion of study participants requiring the use of intravenous antihypertensives [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    The proportion of study participants in each study arm who require any IV antihypertensives to acutely lower blood pressure during their postpartum hospital stay.

  11. Mean daily pain level, as reported by patient on scale from 1-10, stratified by postpartum day [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  12. Use of opioid analgesics, measured in morphine milligram equivalents per day, stratified by postpartum day [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  13. Serum creatinine trend from day of delivery to day of discharge [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
  14. Mean drop in hematocrit from pre-delivery to the nadir prior to discharge [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    Mean difference in hematocrit from pre-delivery to postpartum nadir prior to discharge

  15. Composite of adverse events [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    Adverse events include seizure, stroke, posterior reversible encephalopathy syndrome, repeat course of IV magnesium sulfate for seizure prophylaxis.

  16. Proportion of study participants in each study arm with new onset postpartum elevation of liver function tests (AST, ALT) above twice the normal limit [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    AST: Aspartate aminotransferase; ALT: alanine aminotransferase

  17. Proportion of study participants in each study arm with new onset postpartum acute kidney injury [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    Acute kidney injury is defined as serum creatinine > 1.1mg/dL or double the baseline value

  18. Proportion of study participants in each study arm with delayed postpartum hemorrhage [ Time Frame: duration of postpartum hospitalization (approximately 3-7 days) ]
    Delayed postpartum hemorrhage is defined as > 1000 mL of blood loss occuring > 24 hours after delivery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911701


Locations
Layout table for location information
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Sponsors and Collaborators
University of New Mexico
Investigators
Layout table for investigator information
Principal Investigator: Luis Izquierdo, MD, MBA University of New Mexico

Layout table for additonal information
Responsible Party: Luis Izquierdo, Associate Professor of Clinician Education, University of New Mexico
ClinicalTrials.gov Identifier: NCT02911701     History of Changes
Other Study ID Numbers: 16-147
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Eclampsia
HELLP Syndrome
Pregnancy Complications
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action