Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:02 AM
Study NCT ID:
NCT05758012
Status:
UNKNOWN
Last Update Posted:
2023-03-07
First Post:
2022-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbetocin Compared To Oxytocin During Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'C020731', 'term': 'carbetocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-04', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2023-03-04', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial effects', 'timeFrame': 'immediately before drug administration', 'description': 'Electrocardiograph (QT interval)'}, {'measure': 'Myocardial effects', 'timeFrame': '24 hours after drug administration', 'description': 'Electrocardiograph (QT interval)'}], 'secondaryOutcomes': [{'measure': 'Cardiac enzyme', 'timeFrame': 'immediately before drug administration', 'description': 'Troponin'}, {'measure': 'Cardiac enzyme', 'timeFrame': '24 hours after drug administration', 'description': 'Troponin'}, {'measure': 'Uterine contraction', 'timeFrame': 'One hour post delivery', 'description': 'Palpate the fundus throughout a contraction to determine intensity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Delivery']}, 'referencesModule': {'references': [{'pmid': '30305154', 'type': 'BACKGROUND', 'citation': 'Masuzawa Y, Kataoka Y, Fujii K, Inoue S. Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews. Syst Rev. 2018 Oct 11;7(1):156. doi: 10.1186/s13643-018-0817-3.'}]}, 'descriptionModule': {'briefSummary': 'As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.', 'detailedDescription': 'Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal singleton pregnancy at gestational age of 36 weeks or more.\n* Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)\n* pregnancy after in vitro fertilization\n\nExclusion Criteria:\n\n* placenta praevia or invasive placenta.\n* pre-eclampsia.\n* Bleeding disorder, such as von Willebrand disease type I.\n* Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin).\n* Any known intolerance to either of the study drugs.\n* Prolonged QT-time.\n* Other serious cardiac disease.\n* Liver or kidney failure.'}, 'identificationModule': {'nctId': 'NCT05758012', 'briefTitle': 'Carbetocin Compared To Oxytocin During Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Undesired Effects of Carbetocin Compared To Oxytocin Administered As Single Intravenous Dose or Infusion During Cesarean Delivery: A Prospective Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'IRB0000871251'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'oxytocin group', 'description': 'Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection.', 'interventionNames': ['Drug: oxytocin']}, {'label': 'Carbetocin group', 'description': 'Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection.', 'interventionNames': ['Drug: Carbetocin']}], 'interventions': [{'name': 'oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon'], 'description': "Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders", 'armGroupLabels': ['oxytocin group']}, {'name': 'Carbetocin', 'type': 'DRUG', 'otherNames': ['Pabal'], 'description': "Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders", 'armGroupLabels': ['Carbetocin group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'country': 'Kuwait', 'contacts': [{'name': 'Fatemah Qasem', 'role': 'CONTACT', 'email': 'fatemahq82@gmail.com', 'phone': '+96599511550'}, {'name': 'Mohamed Farghaly', 'role': 'CONTACT', 'email': 'mohamedfarghali@hotmail.com', 'phone': '+96551199166'}], 'facility': 'Munistery of Health Kuwait', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}], 'centralContacts': [{'name': 'Fatemah Qasem', 'role': 'CONTACT', 'email': 'fatemahq82@gmail.com', 'phone': '+98599511550'}, {'name': 'Mohamed Farghaly', 'role': 'CONTACT', 'email': 'mohamedfarghali@hotmail.com', 'phone': '+96551199166'}], 'overallOfficials': [{'name': 'Fatemah Qasem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Kuwait'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'the results of the study will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Kuwait', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia and ICU', 'investigatorFullName': 'Abdelrady S Ibrahim, MD', 'investigatorAffiliation': 'Assiut University'}}}}