Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-29 @ 3:35 PM
Study NCT ID:
NCT04227704
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketamine to Prevent PPD After Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmonks@wustl.edu', 'phone': '314-323-1845', 'title': 'Dr. David Monks', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '42 days', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days postpartum', 'description': 'Establish a sufficient burden of disease (\\>10%) in our population to warrant a full RCT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Eligible Patients Consenting to Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, approximately 9 months', 'description': 'Establish a recruitment rate of greater than 50% to confirm the feasibility of conducting an RCT in our population\n\nTwenty-five (20.7%) out of 121 women who were approached consented to participation. 2 were withdrawn with 23 completing participation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With a Complete Dataset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, approximately 9 months', 'description': 'Ensure that the design of assessments and data collection make it possible to achieve a complete dataset in \\>90% of participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients in Study Arms Experiencing One or More Severe Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, approximately 9 months', 'description': 'Ascertain that neither of the chosen routes of administration of ketamine are intolerable to patients, as defined as the incidence of one or more severe side effects experienced by \\>10% of participants in that study arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dose of Opiate Analgesics Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '63.7', 'groupId': 'OG001'}, {'value': '67.0', 'spread': '22.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Intraoperative supplementary analgesia in morphine milligram equivalents', 'unitOfMeasure': 'Morphine Milligram Equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dose of Ketorolac Administered (mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '0', 'groupId': 'OG000'}, {'value': '30', 'spread': '0', 'groupId': 'OG001'}, {'value': '30', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Intraoperative supplementary analgesia', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Intraoperative Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of participants with intraoperative hypotension of a systolic BP of less than 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Intraoperative Pain (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Reported maximal level of intraoperative pain on the numerical rating scale 0 - 10, where 0 is no pain and 10 is the worst pain imaginable', 'unitOfMeasure': 'Rating Score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'title': 'Mild Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Nausea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Severe Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Moderate vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Severe vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild shivering', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Moderate shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe Shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild sedation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Moderate sedation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Severe sedation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild blurred vision', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate blurred vision', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe blurred vision', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild diplopia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Moderate diplopia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe diplopia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild dizziness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate dizziness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe dizziness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild anxiety', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Moderate anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe anxiety', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mild pruritus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Moderate pruritus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Severe pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Euphoria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Amnesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hallucinations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nystagmus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative and 2 and 6 hours postoperatively', 'description': 'Incidence and severity (mild, moderate or severe) of nausea, vomiting, pruritus, dizziness, sedation, shivering, anxiety, euphoria, hallucinations, amnesia, blurred vision, diplopia, nystagmus', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Ketamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'timeFrame': 'At baseline and approximately 20, 40 and 100 minutes postpartum', 'description': 'Assays of venous blood samples', 'reportingStatus': 'POSTED', 'populationDescription': 'Ketamine assays not performed and therefore no data collected'}, {'type': 'SECONDARY', 'title': 'Total Opiate Consumption in Morphine Equivalents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '63.7', 'groupId': 'OG001'}, {'value': '67', 'spread': '22.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In the first 2 days postpartum', 'description': 'Morphine equivalents', 'unitOfMeasure': 'Morphine Milligram Equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Site Pain: Numerical Rating Scale (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'title': '2 hours postoperatively', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.1428571428571', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': '6 hours postoperatively', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '4.714285714', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '1.875', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': '24 hours postoperatively', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '4.571428571', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': '48 hours postoperatively', 'categories': [{'measurements': [{'value': '3.428571429', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '4.25', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '3.125', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': '21 days postoperatively', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '3.333333333', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.875', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': '42 days postoperatively', 'categories': [{'measurements': [{'value': '0.6666666667', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.333333333', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.285714286', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At 2, 6, 24 and 48 hours after delivery and on postpartum days 21 and 42', 'description': 'Surgical site pain on a numerical rating scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Edinburgh Postpartum Depression Scale (EPDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '4.75', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '4.25', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '8.43', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '5.63', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '5.38', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '12'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '2.83', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '5.14', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '20'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '9.75', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '3.33', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '3.86', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On postpartum days 1, 2, 21 and 42', 'description': "The EPDS is a validated measure of depressive symptoms in the postpartum period. The scale is scored between 0 - 30, a higher score represents greater depressive symptomatology. We report the study mean of each participant's mean EPDS score for their postpartum assessments", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apgar Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'title': 'Apgar 1min', 'categories': [{'measurements': [{'value': '8', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '8', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '8', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Apgar 5 min', 'categories': [{'measurements': [{'value': '9', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '9', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '9', 'spread': '0.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 1 and 5 minutes after delivery', 'description': 'Apgar score (0-10) comprised of an assessment of neonatal color, tone and crying. A higher score indicates healthier color, tone and crying.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Admission to NICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postpartum day 1', 'description': 'Incidence of admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Achieving Breastfeeding Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postpartum days 1 and 2', 'description': 'An indication of whether breastfeeding has been successfully established (Yes or No).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Intraoperative Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of intraoperative hypertension as defined by number of participants with a systolic blood pressure greater than 140 mmHg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Intraoperative Bradycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of intraoperative bradycardia, defined as number of participants with a heart rate of less than 40 bpm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Intraoperative Tachycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of intraoperative tachycardia as defined by the number of participants with a heart rate greater than 110 bpm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postpartum Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'OG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '5.17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '5.63', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '12'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '4.75', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.333333333', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.57', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '2.71', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On day of surgery, and postpartum days 1, 2, 21 and 42', 'description': 'Mean Anxiety in the postpartum. General Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21. Higher scores indicate more severe anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'FG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'FG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'due to anesthesia being changed to general anesthesia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'due to C/S being cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '2 participants withdrew from the study; only 23 had data to report.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'BG001', 'title': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'BG002', 'title': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.\n\nKetamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).\n\nControl: Administration of 0.9% Sodium Chloride (N/S)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '6.53', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '0.95', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '4.30', 'groupId': 'BG002'}, {'value': '31.8', 'spread': '4.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '7.84', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '6.06', 'groupId': 'BG002'}, {'value': '36.8', 'spread': '9.30', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational age (weeks)', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '.76', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '1.11', 'groupId': 'BG001'}, {'value': '38.0', 'spread': '1.11', 'groupId': 'BG002'}, {'value': '38.1', 'spread': '1.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "American Society of Anesthesiologists' (ASA) physical status classification system", 'classes': [{'title': 'ASA II', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'ASA III', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The purpose of the ASA classification system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning), it can be helpful in predicting perioperative risks. Classified as I - IV, with healthier patients being scored as I and sicker patients as IV.", 'unitOfMeasure': 'Participants'}, {'title': 'Insurance status', 'classes': [{'title': 'Insured', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Uninsured', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-operative Anxiety, Depression and Psychosocial Stress screening', 'classes': [{'title': 'Anxiety (GAD-7)', 'categories': [{'measurements': [{'value': '7.29', 'spread': '2.93', 'groupId': 'BG000'}, {'value': '6.13', 'spread': '8.20', 'groupId': 'BG001'}, {'value': '6.25', 'spread': '5.55', 'groupId': 'BG002'}, {'value': '6.52', 'spread': '5.81', 'groupId': 'BG003'}]}]}, {'title': 'Depression (EPDS)', 'categories': [{'measurements': [{'value': '8.29', 'spread': '4.72', 'groupId': 'BG000'}, {'value': '6.25', 'spread': '6.27', 'groupId': 'BG001'}, {'value': '5', 'spread': '4.78', 'groupId': 'BG002'}, {'value': '6.43', 'spread': '5.26', 'groupId': 'BG003'}]}]}, {'title': 'Psychosocial stress (ANRQ)', 'categories': [{'measurements': [{'value': '26.3', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '17', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '14.9', 'spread': '9.25', 'groupId': 'BG002'}, {'value': '19.1', 'spread': '12.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'General Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21. Higher scores indicate more severe anxiety.\n\nEdinburgh Postpartum Depression Scale (EPDS) is a set of ten questions assessing mood in the previous seven days. Scored 0-30. Higher scores indicate greater depressive symptomatology.\n\nThe Antenatal Risk Questionnaire (ANRQ) is a patient-reported psychosocial assessment instrument. Scored 0-23, with higher scores indicating higher psychosocial risk factors.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Psychiatric history', 'classes': [{'title': 'Any psychiatric history', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'PPD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'MDD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Mood disorder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Personality disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Psychotic disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Premenstrual syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Premenstrual dysmorphic disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Panic disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Bipolar affective disorder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Obsessive compulsive disorder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-24', 'size': 223807, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-01T12:53', 'hasProtocol': True}, {'date': '2020-01-28', 'size': 264361, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-01T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The ketamine and placebo study injectates (subcutaneous and intravenous) will be prepared, in way that does not allow differentiation, by pharmacy staff who are otherwise uninvolved in the study. Participants will be allocated to groups using a random sequence generator. The patients, investigators and outcome assessors will remain unaware of their group until data collection is complete for all participants.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised to one of three groups (two interventional and one control).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2019-11-20', 'resultsFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-06', 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30', 'timeFrame': '42 days postpartum', 'description': 'Establish a sufficient burden of disease (\\>10%) in our population to warrant a full RCT'}, {'measure': 'Percentage of Eligible Patients Consenting to Participation', 'timeFrame': 'Through study completion, approximately 9 months', 'description': 'Establish a recruitment rate of greater than 50% to confirm the feasibility of conducting an RCT in our population\n\nTwenty-five (20.7%) out of 121 women who were approached consented to participation. 2 were withdrawn with 23 completing participation.'}, {'measure': 'Percentage of Patients With a Complete Dataset', 'timeFrame': 'Through study completion, approximately 9 months', 'description': 'Ensure that the design of assessments and data collection make it possible to achieve a complete dataset in \\>90% of participants'}, {'measure': 'Number of Patients in Study Arms Experiencing One or More Severe Side Effects', 'timeFrame': 'Through study completion, approximately 9 months', 'description': 'Ascertain that neither of the chosen routes of administration of ketamine are intolerable to patients, as defined as the incidence of one or more severe side effects experienced by \\>10% of participants in that study arm.'}], 'secondaryOutcomes': [{'measure': 'Dose of Opiate Analgesics Administered', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Intraoperative supplementary analgesia in morphine milligram equivalents'}, {'measure': 'Dose of Ketorolac Administered (mg)', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Intraoperative supplementary analgesia'}, {'measure': 'Prevalence of Intraoperative Hypotension', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of participants with intraoperative hypotension of a systolic BP of less than 90'}, {'measure': 'Maximum Intraoperative Pain (NRS)', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Reported maximal level of intraoperative pain on the numerical rating scale 0 - 10, where 0 is no pain and 10 is the worst pain imaginable'}, {'measure': 'Adverse Effects', 'timeFrame': 'Intraoperative and 2 and 6 hours postoperatively', 'description': 'Incidence and severity (mild, moderate or severe) of nausea, vomiting, pruritus, dizziness, sedation, shivering, anxiety, euphoria, hallucinations, amnesia, blurred vision, diplopia, nystagmus'}, {'measure': 'Plasma Concentrations of Ketamine', 'timeFrame': 'At baseline and approximately 20, 40 and 100 minutes postpartum', 'description': 'Assays of venous blood samples'}, {'measure': 'Total Opiate Consumption in Morphine Equivalents', 'timeFrame': 'In the first 2 days postpartum', 'description': 'Morphine equivalents'}, {'measure': 'Surgical Site Pain: Numerical Rating Scale (NRS 0-10)', 'timeFrame': 'At 2, 6, 24 and 48 hours after delivery and on postpartum days 21 and 42', 'description': 'Surgical site pain on a numerical rating scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Edinburgh Postpartum Depression Scale (EPDS)', 'timeFrame': 'On postpartum days 1, 2, 21 and 42', 'description': "The EPDS is a validated measure of depressive symptoms in the postpartum period. The scale is scored between 0 - 30, a higher score represents greater depressive symptomatology. We report the study mean of each participant's mean EPDS score for their postpartum assessments"}, {'measure': 'Apgar Scores', 'timeFrame': 'At 1 and 5 minutes after delivery', 'description': 'Apgar score (0-10) comprised of an assessment of neonatal color, tone and crying. A higher score indicates healthier color, tone and crying.'}, {'measure': 'Admission to NICU', 'timeFrame': 'Postpartum day 1', 'description': 'Incidence of admission'}, {'measure': 'The Number of Participants Achieving Breastfeeding Success', 'timeFrame': 'Postpartum days 1 and 2', 'description': 'An indication of whether breastfeeding has been successfully established (Yes or No).'}, {'measure': 'Prevalence of Intraoperative Hypertension', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of intraoperative hypertension as defined by number of participants with a systolic blood pressure greater than 140 mmHg'}, {'measure': 'Prevalence of Intraoperative Bradycardia', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of intraoperative bradycardia, defined as number of participants with a heart rate of less than 40 bpm'}, {'measure': 'Prevalence of Intraoperative Tachycardia', 'timeFrame': 'Intraoperative phase, approximately 2 hours', 'description': 'Prevalence of intraoperative tachycardia as defined by the number of participants with a heart rate greater than 110 bpm'}, {'measure': 'Postpartum Anxiety', 'timeFrame': 'On day of surgery, and postpartum days 1, 2, 21 and 42', 'description': 'Mean Anxiety in the postpartum. General Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21. Higher scores indicate more severe anxiety.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Depression']}, 'referencesModule': {'references': [{'pmid': '36271352', 'type': 'DERIVED', 'citation': 'Monks DT, Palanisamy A, Jaffer D, Singh PM, Carter E, Lenze S. A randomized feasibility pilot-study of intravenous and subcutaneous administration of ketamine to prevent postpartum depression after planned cesarean delivery under neuraxial anesthesia. BMC Pregnancy Childbirth. 2022 Oct 21;22(1):786. doi: 10.1186/s12884-022-05118-8.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.', 'detailedDescription': "Postpartum depression (PPD)\n\nPPD is one of the most common perinatal medical complications and can have a detrimental effect on both mother and baby. Suicide exceeds hemorrhage and hypertensive disorders as a cause of maternal mortality and maternal psychopathology interferes with the parent-infant relationship. It has been estimated to have a period prevalence of 19.2% in the first 3 postpartum months. The rapid decline in reproductive hormones is thought to contribute to the development of PPD in susceptible women, although the specific pathogenesis is unknown. The American College of Obstetricians and Gynecologists recommend that all women should be routinely screened for depressive symptoms in the perinatal period.\n\nRisk factors for PPD include:\n\n* Depression during pregnancy • Breastfeeding problems\n* Preterm birth/infant admission to neonatal intensive care (NICU)\n* Traumatic birth experience\n* History of depression\n* Anxiety during pregnancy\n\nKetamine's anti-depressant effect\n\nKetamine, a phencyclidine derivative, is a non-competitive antagonist at the N-methyl-D-aspartic acid (NMDA) receptor that is commonly used as an anesthetic or sedative agent and has proven analgesic effect after a variety of surgeries including CD, where it has also been shown to reduce shivering. It has been demonstrated to have a rapid anti-depressant effect in treatment-resistant depression outside of pregnancy. The most commonly employed intravenous (IV) dose for this purpose is 0.5 mg/kg over 40 minutes, as single or repeated infusions. It has been postulated that prolonged blockade of NMDA receptors causes long-term changes in signal transduction leading to sustained clinical improvement, some investigators have explored longer term infusions such as those used to treat chronic pain. A recent pilot study assessing the feasibility of a 96-hour (\\~0.5mg/kg/hr) infusion compared with a single 40-minute (0.5 mg/kg) infusion suggested a trend toward greater efficacy in the prolonged infusion but confirmation of a statistically significant result is awaited.\n\nKetamine and PPD\n\nThis promising anti-depressant effect has prompted investigation of ketamine as a preventative measure in patients undergoing CD. There have been 2 studies to date, one which failed to demonstrate any benefit from a bolus dose of 0.25 mg/kg and one which documented a large reduction (1 and 22% in the treatment and control, respectively) in the (6 week) period prevalence of postpartum depression after a 4 mg/kg dose of ketamine over 50 hours (\\~0.08 mg/kg/hr).\n\nThe prolonged IV infusion, was achieved by adding the ketamine to a sufentanil patient-controlled analgesic (PCA) pump with a background infusion. This PCA pump is a standard part of their post-cesarean analgesic regimen. In our institution, it is standard practice to discontinue IV infusions and to remove IV cannulae as early as it is safe to do so. This practice is essential to the attempts to enhance postoperative recovery and aid mother's bonding with their babies and facilitate their early-life care. This reflects patients' expectations and preferences and is in line with other maternity units across North America and Europe.\n\nThe natural course of PPD varies and, although it may resolve spontaneously within weeks, approximately 20% of women with PPD still have depression at 12 months and beyond. As many as 13% will still have depressive symptoms at 2 years and 40% will have a relapse. Considering the maternal suffering, disruption to the family, potential impairment of the social, emotional, and cognitive development of the child, and the rare cases of infanticide and suicide caused by PPD, the impact on families and society as a whole is difficult to overemphasize. An intervention that promises such a large reduction in this devastating disease warrants extensive research. In an attempt to achieve the benefit whilst employing methods more acceptable to our patients we have designed a pilot study to assess the feasibility of our study design and collect preliminary tolerability and efficacy data on ketamine administered by two alternative routes: 40-minute IV infusion (i.v.) and subcutaneous (s.c.) injection."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Term pregnancy\n* Age 18-45 years of age\n* Scheduled cesarean delivery under neuraxial anesthesia\n\nExclusion criteria:\n\n* ASA classification IV or V\n* History of psychotic episodes\n* History of allergy to ketamine\n* Inability to communicate in English or any other barrier to providing informed consent'}, 'identificationModule': {'nctId': 'NCT04227704', 'acronym': 'PoCKet', 'briefTitle': 'Ketamine to Prevent PPD After Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Postpartum Depression After Cesarean Delivery: Ketamine as a Preventative Intervention: A Feasibility Pilot-study', 'orgStudyIdInfo': {'id': '201910191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.', 'interventionNames': ['Drug: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine SC', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.', 'interventionNames': ['Drug: Ketamine 50 MG/ML', 'Drug: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine IVI', 'description': 'Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.', 'interventionNames': ['Drug: Ketamine 50 MG/ML', 'Drug: Control']}], 'interventions': [{'name': 'Ketamine 50 MG/ML', 'type': 'DRUG', 'description': 'Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).', 'armGroupLabels': ['Ketamine IVI', 'Ketamine SC']}, {'name': 'Control', 'type': 'DRUG', 'description': 'Administration of 0.9% Sodium Chloride (N/S)', 'armGroupLabels': ['Control', 'Ketamine IVI', 'Ketamine SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst Prof of Anesthesiology', 'investigatorFullName': 'David Monks', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}