Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-26 @ 1:12 PM
Study NCT ID:
NCT03978767
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2019-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
Sponsor:
Organization:
Raw JSON
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Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available."}, {'pmid': '23403779', 'type': 'BACKGROUND', 'citation': 'Lo JO, Mission JF, Caughey AB. Hypertensive disease of pregnancy and maternal mortality. Curr Opin Obstet Gynecol. 2013 Apr;25(2):124-32. doi: 10.1097/GCO.0b013e32835e0ef5.'}, {'pmid': '15733721', 'type': 'BACKGROUND', 'citation': 'Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.'}, {'pmid': '29045342', 'type': 'BACKGROUND', 'citation': 'Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.'}, {'pmid': '28885417', 'type': 'BACKGROUND', 'citation': 'Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women at \\> 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:\n* An antepartum diagnosis of preeclampsia with severe features\n* Pre-eclampsia with severe features will be defined as:\n* Elevated blood pressure ≥ 160/110, or\n* Pre-eclampsia in the setting of thrombocytopenia (platelet count \\< 100,000), or\n* Impaired liver function (AST elevated to twice upper limit of normal), or\n* Persistent epigastric pain, or\n* Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or\n* Pulmonary edema, or\n* New onset visual disturbance or headache unresponsive to therapy.\n\nExclusion Criteria:\n\n* NSAID allergy\n* Allergy to acetaminophen\n* Antihypertensive use in this pregnancy prior to 20 weeks gestation\n* Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min\n* Inability to obtain consent\n* Opioid abuse disorder\n* Peptic ulcer disease.'}, 'identificationModule': {'nctId': 'NCT03978767', 'acronym': 'PANDA', 'briefTitle': 'Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial', 'orgStudyIdInfo': {'id': '201901202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NSAID Analgesic bundle', 'description': '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', 'interventionNames': ['Drug: Ibuprofen 600 mg', 'Drug: Ketorolac', 'Drug: Acetaminophen', 'Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSAID free analgesic bundle', 'description': 'Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Oxycodone']}], 'interventions': [{'name': 'Ibuprofen 600 mg', 'type': 'DRUG', 'description': 'NSAID pain medication to be used in the experimental bundle for postpartum analgesia', 'armGroupLabels': ['NSAID Analgesic bundle']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section', 'armGroupLabels': ['NSAID Analgesic bundle']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Analgesic medication to be used in both treatment arms', 'armGroupLabels': ['NSAID Analgesic bundle', 'NSAID free analgesic bundle']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Analgesic medication to be used in both treatment arms', 'armGroupLabels': ['NSAID Analgesic bundle', 'NSAID free analgesic bundle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Hirshberg, MD', 'role': 'CONTACT', 'email': 'jhirshberg@wustl.edu', 'phone': '314-362-5000'}], 'facility': 'Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Jonathan S Hirshberg, MD', 'role': 'CONTACT', 'email': 'jhirshberg@wustl.edu', 'phone': '314-362-5000'}, {'name': 'Tracy Burger', 'role': 'CONTACT', 'email': 'tburger@wustl.edu', 'phone': '3147471390'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}