Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-03 @ 5:01 AM
Study NCT ID:
NCT00499005
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2007-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbetocin Versus Syntometrine for the Third Stage of Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020731', 'term': 'carbetocin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-18', 'studyFirstSubmitDate': '2007-07-09', 'studyFirstSubmitQcDate': '2007-07-10', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Postpartum haemorrhage (less than or equal to 500 ml) 2. Postpartum haemorrhage (less than or equal to 1000ml) 3. Use of additional uterotonic therapy', 'timeFrame': 'Within 2 hours after delivery'}], 'secondaryOutcomes': [{'measure': '1. Adverse effects with the intervention which include headache, nausea, vomiting, elevation of blood pressure and retained placenta 2. Cost effectiveness analysis of the intervention', 'timeFrame': 'Within 2 hours after delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postpartum Haemorrhage']}, 'descriptionModule': {'briefSummary': 'Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage', 'detailedDescription': 'Postpartum haemorrhage(PPH)or excessive bleeding at or after childbirth is a potentially life threatening complication and is one of the major contributors to maternal mortality and morbidity worldwide (Lewis 2001).Among the various agents that have been studied in addition to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist (carbetocin) appears to be the most promising for this indication(Chong 2004).\n\nCarbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in Singapore and many other countries. It is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties.The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. In pharmacokinetic studies, intravenous injections of carbetocin produced tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic contractions for a further hour.Intramuscular injection produced tetanic contractions in less than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an additional two hours. The prolonged duration of activity after intramuscular compared with the intravenous carbetocin was significant(Hunter 1992). In comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions.\n\nThe potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action. Its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any pregnant woman expected to deliver vaginally\n2. Age more than 21 if not married\n3. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Multiple pregnancy\n2. Patients with other risk factors for postpartum haemorrhage\n3. Patients planning to have an elective caesarean section\n4. History of vascular disease such as coronary artery disease\n5. History of hypertension requiring treatment within the last 2 years\n6. History of hepatic or renal disease\n7. Known or suspected coagulopathy\n8. History of hypersensitivity to oxytocin or carbetocin\n9. Any condition where the use of syntometrine/carbetocin is contraindicated'}, 'identificationModule': {'nctId': 'NCT00499005', 'briefTitle': 'Carbetocin Versus Syntometrine for the Third Stage of Labour', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial', 'orgStudyIdInfo': {'id': 'DSRB Ref: D/04/209'}, 'secondaryIdInfos': [{'id': 'NHG-SIG/07059'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Primi', 'interventionNames': ['Drug: Syntommetrine and Carbetocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi', 'interventionNames': ['Drug: Syntommetrine and Carbetocin']}], 'interventions': [{'name': 'Syntommetrine and Carbetocin', 'type': 'DRUG', 'description': 'Syntommetrine 1ml and Carbetocin 100microgram', 'armGroupLabels': ['Multi', 'Primi']}, {'name': 'Syntommetrine and Carbetocin', 'type': 'DRUG', 'description': 'Syntommetrine 1ml and Carbetocin 100micgrams', 'armGroupLabels': ['Multi', 'Primi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Su Lin Lin, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Healthcare Group, Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Chong Yap Seng, MBBS', 'oldOrganization': 'National HealthCare Group, Singapore'}}}}