Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 9:54 PM
Study NCT ID:
NCT00989027
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Uterotonic Agents on Isolated Human Myometrium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D004874', 'term': 'Ergonovine'}, {'id': 'D002260', 'term': 'Carboprost'}, {'id': 'C062843', 'term': 'carboprost tromethamine'}], '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': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011461', 'term': 'Prostaglandins F, 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of contraction', 'timeFrame': '6-8 hours'}], 'secondaryOutcomes': [{'measure': 'Integrated area under response curve (AUC)', 'timeFrame': '6-8 hours'}, {'measure': 'Basal tone', 'timeFrame': '6-8 hours'}, {'measure': 'Frequency of contraction', 'timeFrame': '6-8 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine contraction', 'Dose-response', 'Oxytocin pre-treatment'], 'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known.\n\nThe investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.', 'detailedDescription': 'Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).\n\nPatients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. This information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 37-41 weeks\n* Non-laboring patients, not exposed to exogenous oxytocin\n* Patients requiring primary Cesarean section\n* Cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who require general anesthesia\n* Patient who had previous uterine surgery or Cesarean section\n* Patients with placental anomalies\n* Emergency Cesarean section in labor\n* Patients with bleeding disorders'}, 'identificationModule': {'nctId': 'NCT00989027', 'briefTitle': 'Impact of Uterotonic Agents on Isolated Human Myometrium', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Impact of Uterotonic Agents on Isolated Human Myometrium', 'orgStudyIdInfo': {'id': '07-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.', 'interventionNames': ['Drug: Oxytocin', 'Drug: Ergonovine', 'Drug: Carboprost', 'Drug: Oxytocin and Ergonovine', 'Drug: Oxytocin and Carboprost']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.', 'armGroupLabels': ['Treatment']}, {'name': 'Ergonovine', 'type': 'DRUG', 'otherNames': ['Ergonovine Maleate'], 'description': 'Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.', 'armGroupLabels': ['Treatment']}, {'name': 'Carboprost', 'type': 'DRUG', 'otherNames': ['Hemabate'], 'description': 'Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.', 'armGroupLabels': ['Treatment']}, {'name': 'Oxytocin and Ergonovine', 'type': 'DRUG', 'otherNames': ['Oxytocin', 'Ergonovine'], 'description': 'Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.', 'armGroupLabels': ['Treatment']}, {'name': 'Oxytocin and Carboprost', 'type': 'DRUG', 'otherNames': ['Oxytocin', 'Hemabate'], 'description': 'Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Mrinalini Balki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}