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Trial record 53 of 152 for:    severe preeclampsia AND Pregnancy Complications

Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial (PANDA)

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ClinicalTrials.gov Identifier: NCT03978767
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan (Jake) Hirshberg, Washington University School of Medicine

Brief Summary:
A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.

Condition or disease Intervention/treatment Phase
Preeclampsia Severe Preeclampsia Postpartum Drug: Ibuprofen 600 mg Drug: Ketorolac Drug: Acetaminophen Drug: Oxycodone Phase 2

Detailed Description:

Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions.

The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized non-inferiority clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : May 27, 2021
Estimated Study Completion Date : July 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: NSAID Analgesic bundle
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
Drug: Ibuprofen 600 mg
NSAID pain medication to be used in the experimental bundle for postpartum analgesia

Drug: Ketorolac
NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section

Drug: Acetaminophen
Analgesic medication to be used in both treatment arms

Drug: Oxycodone
Analgesic medication to be used in both treatment arms

Active Comparator: NSAID free analgesic bundle
Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.
Drug: Acetaminophen
Analgesic medication to be used in both treatment arms

Drug: Oxycodone
Analgesic medication to be used in both treatment arms




Primary Outcome Measures :
  1. postpartum antihypertensive requirements [ Time Frame: at the end of hospitalization, up to 7 days after randomization ]
    measurement of anti-hypertensive requirements at time of discharge


Secondary Outcome Measures :
  1. Postpartum pain scores [ Time Frame: From randomization to 6 weeks after randomization ]
    Evaluate the effect of NSAIDs on patient perception of pain

  2. Postpartum opioid use [ Time Frame: From randomization to 6 weeks after randomization ]
    Compare the opioid requirements in each arm

  3. Mean arterial blood pressure [ Time Frame: From randomization to 6 weeks after randomization ]
    Compare peak, average and median MAPs postpartum

  4. End organ damage [ Time Frame: during hospitalization, an average of 4 days ]
    Evaluate for evidence of renal, hepatic or neurological injury in the poatpartum period

  5. Hospital readmission [ Time Frame: From randomization to 6 weeks after randomization ]
    Evaluate the incidence of hospital readmission rate postpartum

  6. Continued anti-hypertensive requirement [ Time Frame: up to 6 weeks ]
    evaluate the need for antihypertensive medications at 6 weeks postpartum



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women at > 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:
  • An antepartum diagnosis of preeclampsia with severe features
  • Pre-eclampsia with severe features will be defined as:
  • Elevated blood pressure ≥ 160/110, or
  • Pre-eclampsia in the setting of thrombocytopenia (platelet count < 100,000), or
  • Impaired liver function (AST elevated to twice upper limit of normal), or
  • Persistent epigastric pain, or
  • Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or
  • Pulmonary edema, or
  • New onset visual disturbance or headache unresponsive to therapy.

Exclusion Criteria:

  • NSAID allergy
  • Allergy to acetaminophen
  • Antihypertensive use in this pregnancy prior to 20 weeks gestation
  • Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min
  • Inability to obtain consent
  • Opioid abuse disorder
  • Peptic ulcer disease.

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): NCT03978767


Contacts
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Contact: Jonathan S Hirshberg, MD 314-362-5000 jhirshberg@wustl.edu
Contact: Tracy Burger 3147471390 tburger@wustl.edu

Locations
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United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jonathan Hirshberg, MD    314-362-5000    jhirshberg@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Jonathan (Jake) Hirshberg, Washington University School of Medicine:
Statistical Analysis Plan  [PDF] June 3, 2019
Study Protocol  [PDF] April 9, 2019
Informed Consent Form  [PDF] April 12, 2019


Publications:
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Responsible Party: Jonathan (Jake) Hirshberg, Clinical Fellow, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03978767     History of Changes
Other Study ID Numbers: 201901202
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jonathan (Jake) Hirshberg, Washington University School of Medicine:
NSAIDs
Ibuprofen
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Acetaminophen
Ibuprofen
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Oxycodone
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants