Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-07 @ 6:46 AM
Study NCT ID:
NCT02079558
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2014-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-12', 'releaseDate': '2015-06-01'}], 'estimatedResultsFirstSubmitDate': '2015-06-01'}}, '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'}, {'id': 'D010121', 'term': 'Oxytocin'}], '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'screening of Cessation of bleeding', 'timeFrame': 'screening until 24 hours after placenta disconnection'}, {'measure': 'time duration to stop bleeding in the case of post-cesarean section', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prevention', 'cesarean section'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '28707488', 'type': 'DERIVED', 'citation': 'Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin\n\nExclusion Criteria:\n\n* Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia"}, 'identificationModule': {'nctId': 'NCT02079558', 'briefTitle': 'Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section', 'orgStudyIdInfo': {'id': 'IRHRC-021'}, 'secondaryIdInfos': [{'id': 'JANU2014TAHERIPANAH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'A single 100 microgram IV dose of carbetocin after operation', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'Carbetocin', 'description': 'A standard 30 international units (IU) IV infusion of oxytocin during two hours', 'interventionNames': ['Drug: Carbetocin']}], 'interventions': [{'name': 'Carbetocin', 'type': 'DRUG', 'otherNames': ['Duratocin,', 'Pabal,', 'Lonactene'], 'description': 'Carbetocin with single 100 microg IV dosage was used in this investigation', 'armGroupLabels': ['Carbetocin']}, {'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Pitocin'], 'description': 'Oxytocin with 30 international units (IU) IV infusion was used in this investigation', 'armGroupLabels': ['Oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1985717443', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Infertility and Reproductive Health Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Robabeh Taheripanah, MD-Gyn.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated prof. Obstetrics & Gynecology', 'investigatorFullName': 'Dr Robabeh Taheripanah', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-06-01', 'type': 'RELEASE'}, {'date': '2015-06-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr Robabeh Taheripanah, Associated prof. Obstetrics & Gynecology, Shahid Beheshti University of Medical Sciences'}}}}