Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-27 @ 5:50 PM
Study NCT ID:
NCT03870503
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2019-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage
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': 'D010121', 'term': 'Oxytocin'}, {'id': 'D016595', 'term': 'Misoprostol'}, {'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'}, {'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will be a prospective double-blind randomized study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be a prospective double-blind randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-03-09', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of blood loss', 'timeFrame': '6 hours post delivery', 'description': 'calculation of the amount of blood loss by weighing the swabs and using pictorial charts'}], 'secondaryOutcomes': [{'measure': 'The number of patients develop blood loss more than 1000 ml', 'timeFrame': '24 hours post delivery', 'description': 'Calculation of the number of patients develop blood loss more than 1000 ml'}, {'measure': 'The number of patient need blood transfusion', 'timeFrame': '24 hours post delivery', 'description': 'Calculation of number of patient need blood transfusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum Hemorrhage', 'vaginal delivery', 'carbetocin', 'misoprostol', 'oxytocin'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '33232518', 'type': 'DERIVED', 'citation': 'Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.', 'detailedDescription': 'The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.\n\nOxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'All participants had PPH defined as vaginal bleeding\\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants had PPH defined as vaginal bleeding\\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation\n\nExclusion Criteria:\n\n* gestational age\\<37 weeks,\n* genital tract trauma,\n* coagulation defect,\n* women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy\n* known hypersensitivity to carbetocin or oxytocin.'}, 'identificationModule': {'nctId': 'NCT03870503', 'briefTitle': 'Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/201/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oxytocin', 'description': 'The patient will be received oxytocin 20 IU by intravenous infusion', 'interventionNames': ['Drug: oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oxytocin plus misoprostol', 'description': 'The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol', 'interventionNames': ['Drug: oxytocin', 'Drug: oxytocin plus misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbetocin', 'description': 'The patient will be received Carbetocin 100 mic gm IV', 'interventionNames': ['Drug: Carbetocin']}], 'interventions': [{'name': 'oxytocin', 'type': 'DRUG', 'otherNames': ['Active comparator'], 'description': 'The patient will be received oxytocin 20 IU by intravenous infusion', 'armGroupLabels': ['oxytocin', 'oxytocin plus misoprostol']}, {'name': 'oxytocin plus misoprostol', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol', 'armGroupLabels': ['oxytocin plus misoprostol']}, {'name': 'Carbetocin', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'The patient received Carbetocin 100 mic gm', 'armGroupLabels': ['Carbetocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'hany f allam, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}