Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02872935
Status:
TERMINATED
Last Update Posted:
2020-06-09
First Post:
2016-08-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Minimizing Nausea and Vomiting During Spinals for CS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kokila-thenuwara@uiowa.edu', 'phone': '319-384-5876', 'title': 'Dr. Kokila Thenuwara', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo: Normal Saline', 'description': '1ml of Normal Saline will be given intravenously with the administering of the spinal dose\n\nNormal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glycopyrrolate Group', 'description': '1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose\n\nGlycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Normal Saline', 'description': '1ml of Normal Saline will be given intravenously with the administering of the spinal dose\n\nNormal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose'}, {'id': 'OG001', 'title': 'Glycopyrrolate Group', 'description': '1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose\n\nGlycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes', 'description': 'Did the subject report nausea? The subject will respond with yes or no.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Vomiting.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Normal Saline', 'description': '1ml of Normal Saline will be given intravenously with the administering of the spinal dose\n\nNormal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose'}, {'id': 'OG001', 'title': 'Glycopyrrolate Group', 'description': '1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose\n\nGlycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes', 'description': 'This measure is observed by care team. Reported as vomiting, yes or no.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo: Normal Saline', 'description': '1ml of Normal Saline will be given intravenously with the administering of the spinal dose\n\nNormal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose'}, {'id': 'FG001', 'title': 'Glycopyrrolate Group', 'description': '1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose\n\nGlycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'comment': 'One subject consented but did no proceed with the study.', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo: Normal Saline', 'description': '1ml of Normal Saline will be given intravenously with the administering of the spinal dose\n\nNormal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose'}, {'id': 'BG001', 'title': 'Glycopyrrolate Group', 'description': '1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose\n\nGlycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2016-08-05', 'resultsFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-28', 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Reported Nausea', 'timeFrame': 'From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes', 'description': 'Did the subject report nausea? The subject will respond with yes or no.'}, {'measure': 'Number of Participants Who Experienced Vomiting.', 'timeFrame': 'From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes', 'description': 'This measure is observed by care team. Reported as vomiting, yes or no.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Nausea', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '16192541', 'type': 'BACKGROUND', 'citation': 'Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.'}, {'pmid': '10995148', 'type': 'BACKGROUND', 'citation': 'Abouleish EI, Rashid S, Haque S, Giezentanner A, Joynton P, Chuang AZ. Ondansetron versus placebo for the control of nausea and vomiting during Caesarean section under spinal anaesthesia. Anaesthesia. 1999 May;54(5):479-82. doi: 10.1046/j.1365-2044.1999.00798.x.'}, {'pmid': '10823097', 'type': 'BACKGROUND', 'citation': 'Harmon D, Ryan M, Kelly A, Bowen M. Acupressure and prevention of nausea and vomiting during and after spinal anaesthesia for caesarean section. Br J Anaesth. 2000 Apr;84(4):463-7. doi: 10.1093/oxfordjournals.bja.a013471.'}, {'pmid': '34002866', 'type': 'DERIVED', 'citation': 'Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.'}]}, 'descriptionModule': {'briefSummary': 'In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.', 'detailedDescription': 'The hypothesis of this study is as follows: In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.\n\nThe study group will receive phenylephrine infusion \\[dilution 100micrograms /cc\\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given .4mg \\[1cc of glycopyrrolate\\], with the starting of the infusion\n\nThe control group, will receive phenylephrine infusion \\[dilution 100micrograms /cc\\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given a placebo \\[1cc of N saline\\], with the starting of the infusion\n\nFollowing the administration of the study drug/placebo, the patient will be monitored for severity of nausea , vomiting and pain at 5 minutes intervals from placement of the spinal to delivery of the baby, and then at 15 minutes intervals from delivery of the baby till the end of the surgery ( the cesarean section)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant\n2. American Society of Anesthesiologists risk classification I and II\n3. Age \\> 18 years\n4. Non-laboring\n5. Patients with elective cesarean sections\n\nExclusion Criteria:\n\n1. Non- English speakers\n2. Height \\< 4\' 11"\n3. BMI \\>40 Kg/ mm\n4. Antiemetic drug use in the 24 hours prior to cesarean delivery,\n5. Hypertensive diseases of pregnancy\n6. Chronic hypertension receiving antihypertensive treatment\n7. Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.'}, 'identificationModule': {'nctId': 'NCT02872935', 'briefTitle': 'Minimizing Nausea and Vomiting During Spinals for CS', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Randomized Double Control Study to Assess the Efficacy of Administering 1 ml of Glycopyrrolate With the Spinal Dose in Minimizing Nausea and Vomiting in Patients Undergoing Cesarean Section Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': '201301793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: Normal Saline', 'description': '1ml of Normal Saline will be given intravenously with the administering of the spinal dose', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate group', 'description': '1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose', 'interventionNames': ['Drug: Glycopyrrolate']}], 'interventions': [{'name': 'Glycopyrrolate', 'type': 'DRUG', 'otherNames': ['Robinul'], 'description': '.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose', 'armGroupLabels': ['Glycopyrrolate group']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['.9% saline'], 'description': '1ml of normal saline will be given intravenously with the administration of the spinal dose', 'armGroupLabels': ['Placebo: Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Kokila N Thenuwara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Do not plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kokila N Thenuwara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Kokila N Thenuwara', 'investigatorAffiliation': 'University of Iowa'}}}}