Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT04191694
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chewing Gum to Prevent Nausea and Vomiting After Caesarean Section Under Spinal Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in the number of episodes of self-reported nausea', 'timeFrame': '24 hours post caesarean section', 'description': 'Self-reported nausea described to investigator'}, {'measure': 'The difference in the number of episodes of self-reported vomiting', 'timeFrame': '24 hours post caesarean section', 'description': 'Self-reported number of episodes of vomiting described to investigator'}], 'secondaryOutcomes': [{'measure': 'Episodes of nausea, vomiting or both in recovery room and at 24 hours after caesarean section.', 'timeFrame': '24 hours post caesarean section', 'description': 'Number of episodes of nausea or vomiting experienced by women'}, {'measure': 'Severity of nausea, reported as the worst episode in the last 24 hours', 'timeFrame': '24 hours post caesarean section', 'description': 'Severity on a scale from 0-10, 0 being no nausea, 10 being extremely severe'}, {'measure': 'Antiemetics in the first 24 hours after Caesarean section under spinal anaesthesia', 'timeFrame': '24 hours post caesarean section', 'description': 'Number of doses of anti-emetic medication and the type of antiemetic given to women following their caesarean sections'}, {'measure': 'Patient satisfaction with the intervention', 'timeFrame': '24 hours post caesarean section', 'description': 'Patient satisfaction on 0 - 10 scale and Patient Reported Outcome Measure (PROM) - Obstetric Quality of Recovery (ObsQoR-11), currently part of the routine pain round'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PONV']}, 'referencesModule': {'references': [{'pmid': '36404985', 'type': 'DERIVED', 'citation': 'Bowe R, Irwin R, Browne G, Harbison M, Gallen S, Yore PJ, MacGearailt E, Popivanov P, Tan T. Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section: a Pilot Randomised Controlled Trial. SN Compr Clin Med. 2022;4(1):257. doi: 10.1007/s42399-022-01332-9. Epub 2022 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'Our study aims to determine if there is a difference in a self-reported incidence of nausea and vomiting in women who are given chewing gum following elective caesarean section under spinal anaesthesia compared to those who do not receive chewing gum', 'detailedDescription': 'Caesarean section is one of the most commonly performed surgical procedures worldwide and the rate continues to rise. It is most often performed under regional anaesthesia, like spinal or epidural with long acting opioids such as spinal morphine added to improve postoperative pain in the first 24 hours.\n\nHowever, nausea and vomiting is a common side effect of spinal morphine. Other risk factors for nausea and vomiting are patient related (female, non-smoker, history of post-operative nausea and vomiting \\[PONV\\] and/or motion sickness) and surgery related (spinal induced hypotension, blood loss, vagal stimulation, uterine exteriorisation, uterotonics, i.v. opioids etc). Risk assessment tools are available to estimate the risk of PONV for each patient.\n\nThe incidence of post-caesarean section nausea and vomiting at Coombe Women and Infants University Hospital is 28% and worldwide rates range from 21%-79%.\n\nIn the context of Enhanced Recovery After Surgery (ERAS), experiencing nausea and vomiting is distressing, reduces patient satisfaction by delaying early eating, drinking and mobilisation, interrupts bonding with the baby and prolongs hospital discharge.\n\nIt has been demonstrated that chewing gum is not inferior to 4 mg Ondansetron in treating nausea and vomiting post breast and laparoscopic surgery in female patients. It also has been shown to improve the return of gastrointestinal function after major surgery.\n\nTo our knowledge, no study has assessed the role of chewing gum for preventing nausea and vomiting after caesarean section under spinal anaesthetic.\n\nOur study aims to assess whether or not chewing gum helps to reduce the self-reported incidence of nausea and vomiting in women undergoing caesarean section under spinal anaesthesia when compared to a control group who will not receive chewing gum.\n\nThere will be two arms of our study. Both arms will receive as standard Ondansetron 4mg intra-operatively.\n\nOne arm, the intervention arm, will then receive chewing gum, initially in the recovery room after their procedure and then will receive chewing gum to chew over the first 24 hours after their procedure according to their preference.\n\nThe second arm will not receive the chewing gum intervention.\n\nEach arm will be followed up in the theatre recovery room after their procedure - determining any episodes of nausea or vomiting in the recovery room and the severity of episodes and whether any anti-emetic was given.\n\nEach arm will also be followed up 24 hours later, asking them to report the number of episodes of nausea or vomiting they experienced in the 24 hours following their caesarean section and to assign the severity of their nausea or vomiting a number between 0-10,0 being none, 10 being most severe. The intervention arm will be asked how long they chewed chewing gum for in the first 24 hours after their procedure. The intervention arm will also be asked to rate their satisfaction with the intervention on a scale of 0-10, 0 being not satisfied, 10 being extremely satisfied.\n\nAll patients undergoing caesarean section will be considered for selection.\n\nPatients will be identified at the pre-assessment clinic. At this review, patients will be identified for screening and will be assessed for eligibility.\n\nThe study will be discussed with them and they will be given a patient information leaflet.\n\nInformed consent will be obtained prior to any study related procedures being undertaken.\n\nThe participants will be given a patient information leaflet prior to consent being taken. The information leaflet will be provided in simple and clear language. All patients will be informed of the objectives, benefits, risks and obligations imposed by the study. This discussion and consent will be performed in the pre-assessment clinic, thus allowing sufficient time to contemplate participation in the trial. Any questions or concerns will be addressed prior to consent being obtained. Informed consent will be obtained by an anaesthetic registrar on admission to hospital.\n\nThe study will be investigator led, single centre, randomised, unblind double arm comparator study'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal Anaesthesia\n* Elective\n* Able and Agreeable to chew chewing gum in recovery room and in the first 24 hours\n* Received Ondansetron 4mg IV intra-operatively\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus\n* Nausea and/or Vomiting on arrival to recovery room\n* Post-partum haemorrhage \\>1000ml\n* Ergometrine or Misoprostol intra-operatively\n* Intravenous opioid intra-operatively'}, 'identificationModule': {'nctId': 'NCT04191694', 'briefTitle': 'Chewing Gum to Prevent Nausea and Vomiting After Caesarean Section Under Spinal Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Coombe Women and Infants University Hospital'}, 'officialTitle': 'Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '17-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively)', 'interventionNames': ['Drug: Ondansetron 4 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chewing Gum', 'description': 'Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) they will also receive chewing in the recovery room and on the post-natal ward.', 'interventionNames': ['Other: Chewing Gum', 'Drug: Ondansetron 4 MG']}], 'interventions': [{'name': 'Chewing Gum', 'type': 'OTHER', 'description': 'Patients will be given a packet of chewing gum on arrival in the post-operative recovery room. They will be asked to start chewing gum in the recovery room and then asked to chew gum according to their preference over course of the following 24 hours.', 'armGroupLabels': ['Chewing Gum']}, {'name': 'Ondansetron 4 MG', 'type': 'DRUG', 'description': 'Ondansetron 4mg intravenously, intra-operatively as part of standard hospital caesarean section protocol', 'armGroupLabels': ['Chewing Gum', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Petar Popivanov', 'role': 'CONTACT', 'phone': '014085200'}], 'facility': 'Coombe Women and Infants University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'centralContacts': [{'name': 'Petar Popivanov', 'role': 'CONTACT', 'email': 'ppopivanov@coombe.ie', 'phone': '014085662'}, {'name': 'Terry Tan', 'role': 'CONTACT', 'email': 'ttan@coombe.ie', 'phone': '014085662'}], 'overallOfficials': [{'name': 'Terry Tan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coombe Women and Infants University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coombe Women and Infants University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Petar Popivanov', 'investigatorAffiliation': 'Coombe Women and Infants University Hospital'}}}}