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Trial record 62 of 168 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 : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan (Jake) Hirshberg, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 18, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date August 10, 2020
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date May 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Postpartum pain scores [ Time Frame: From randomization to 6 weeks after randomization ]
    Evaluate the effect of NSAIDs on patient perception of pain
  • Postpartum opioid use [ Time Frame: From randomization to 6 weeks after randomization ]
    Compare the opioid requirements in each arm
  • Mean arterial blood pressure [ Time Frame: From randomization to 6 weeks after randomization ]
    Compare peak, average and median MAPs postpartum
  • 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
  • Hospital readmission [ Time Frame: From randomization to 6 weeks after randomization ]
    Evaluate the incidence of hospital readmission rate postpartum
  • Continued anti-hypertensive requirement [ Time Frame: up to 6 weeks ]
    evaluate the need for antihypertensive medications at 6 weeks postpartum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
Official Title  ICMJE Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized non-inferiority clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Preeclampsia Severe
  • Preeclampsia Postpartum
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Ibuprofen 600 mg
    • Drug: Ketorolac
    • Drug: Acetaminophen
    • Drug: Oxycodone
  • 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.
    Interventions:
    • Drug: Acetaminophen
    • Drug: Oxycodone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
286
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 27, 2021
Estimated Primary Completion Date May 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan S Hirshberg, MD 314-362-5000 jhirshberg@wustl.edu
Contact: Tracy Burger 3147471390 tburger@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978767
Other Study ID Numbers  ICMJE 201901202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan (Jake) Hirshberg, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP