Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-07 @ 10:55 PM
Study NCT ID:
NCT00481533
Status:
COMPLETED
Last Update Posted:
2007-06-01
First Post:
2007-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-30', 'studyFirstSubmitDate': '2007-05-30', 'studyFirstSubmitQcDate': '2007-05-30', 'lastUpdatePostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of Uterine Contraction', 'timeFrame': 'During surgery'}, {'measure': 'Side Effects', 'timeFrame': 'During surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cesarean Delivery', 'Uterine Contractility'], 'conditions': ['Blood Loss, Surgical']}, 'referencesModule': {'references': [{'pmid': '18333937', 'type': 'DERIVED', 'citation': 'Balki M, Dhumne S, Kasodekar S, Kingdom J, Windrim R, Carvalho JC. Oxytocin-ergometrine co-administration does not reduce blood loss at caesarean delivery for labour arrest. BJOG. 2008 Apr;115(5):579-84. doi: 10.1111/j.1471-0528.2007.01658.x.'}]}, 'descriptionModule': {'briefSummary': "Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.\n\nPatients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.", 'detailedDescription': "Despite of marked improvements in management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in Obstetrics. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.\n\nProphylactic oxytocin, commonly administered after fetal and placental delivery, has been shown to reduce the incidence of PPH. The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine. The effect of oxytocin is limited by the number and status of the oxytocin receptors. Increases in the dose of oxytocin will not necessarily improve uterine contraction, if receptors are not adequate in quantity and quality.This is the cause of patients exposed to oxytocin for labor augmentation, in whom oxytocin receptors are known to reduce both number and response to oxytocin. Therefore, a different uterotonic agent, involving a different mechanism of action should be used instead. Alternative drugs include ergot derivatives and prostaglandins (carboprost and misoprostol). Although protection from PPH with ergot derivatives and prostaglandin appear to be similar, prostaglandins are associated with more side effects.\n\nPatients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cesarean section secondary to failure to progress in labour\n* First stage of labour\n* Received oxytocin for at least 4 hours\n\nExclusion Criteria:\n\n* Require General Anesthesia\n* Cardiac Disease\n* Hypertension\n* Predisposition to uterine atony and postpartum hemorrhage'}, 'identificationModule': {'nctId': 'NCT00481533', 'briefTitle': 'Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour', 'orgStudyIdInfo': {'id': '07-07'}, 'secondaryIdInfos': [{'id': '05-0042-A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Methyl-Ergonovine-Oxytocin', 'type': 'DRUG'}, {'name': 'Oxytocin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jose CA Carvalho, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}}}}