Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-20 @ 1:31 PM
Study NCT ID:
NCT01869556
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2013-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress
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': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-22', 'studyFirstSubmitDate': '2013-05-31', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for additional uterotonics intraoperatively', 'timeFrame': '1 hour', 'description': 'Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of uterine contraction', 'timeFrame': '10 min', 'description': 'Adequate/inadequate uterine tone at 3,5 \\& 10 min'}, {'measure': 'Need for blood transfusion', 'timeFrame': '24 hours', 'description': 'Any blood products administered'}, {'measure': 'Vital signs', 'timeFrame': '2 hours', 'description': 'In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities'}, {'measure': 'Side effects', 'timeFrame': '24 hours', 'description': 'The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded.'}, {'measure': 'Estimated blood loss', 'timeFrame': '48 hours', 'description': "calculated blood loss = EBV (Pre-op Htc-Post-op Htc) EBV (estimated blood volume, mL)=patient's weight in kg x 85"}, {'measure': 'Need for additional uterotonics or interventions post-operatively', 'timeFrame': '24 hours', 'description': 'Need for additional uterotonics or interventions post-operatively up to 24 hours post-partum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'postpartum hemorrhage', 'Cesarean delivery', 'failure to progress in labor'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '33543897', 'type': 'DERIVED', 'citation': 'Balki M, Downey K, Walker A, Seaward G, Carvalho JCA. Prophylactic Administration of Uterotonics to Prevent Postpartum Hemorrhage in Women Undergoing Cesarean Delivery for Arrest of Labor: A Randomized Controlled Trial. Obstet Gynecol. 2021 Mar 1;137(3):505-513. doi: 10.1097/AOG.0000000000004288.'}]}, 'descriptionModule': {'briefSummary': 'Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.', 'detailedDescription': 'The objective of the investigators study is to compare the efficacy of intravenous ergonovine and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to decrease blood loss at Cesarean section for labor arrest. Desensitization of the oxytocin receptors has been recently demonstrated in cultured human myometrial cells after continuous and prolonged exposure to oxytocin in-vitro. This could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and augmentation of labor. Therefore, addition of a different uterotonic agent, involving a different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in women undergoing CS following failure to progress in labor, who are at a greater risk for PPH.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who give written informed consent\n* patients undergoing Cesarean section for failure to progress in labour, under regional anesthesia\n* patients should be in the first stage of labour and have received oxytocin for at least 4 hours\n\nExclusion Criteria:\n\n* patients who refuse to give written informed consent\n* patients who require general anesthesia\n* patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins\n* patients with cardiac diseases and hypertension or preeclampsia ( diastolic blood pressure \\> 90 mmHg, systolic blood pressure \\> 140 mmHg )\n* patients with asthma or any other respiratory disease\n* patients with conditions at risk of PPH such as placenta previa, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, bleeding diathesis and known infection.'}, 'identificationModule': {'nctId': 'NCT01869556', 'briefTitle': 'Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Comparison of Intravenous Ergonovine With Intramuscular Carboprost, Both in Combination With Oxytocin Infusion, During Cesarean Section for Failure to Progress in Labor: A Double-blinded Placebo-controlled Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '13-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin only', 'description': 'Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin + Ergot', 'description': 'Oxytocin 5IU IV bolus + Ergot 0.25mg IV, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours', 'interventionNames': ['Drug: Oxytocin', 'Drug: Ergot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin + Carboprost', 'description': 'Oxytocin 5IU IV bolus + Carboprost 0.25mg IM, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours', 'interventionNames': ['Drug: Oxytocin', 'Drug: Carboprost']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['syntocinon'], 'description': 'Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours', 'armGroupLabels': ['Oxytocin + Carboprost', 'Oxytocin + Ergot', 'Oxytocin only']}, {'name': 'Ergot', 'type': 'DRUG', 'otherNames': ['ergonovine maleate'], 'description': 'Ergot 0.25mg IV', 'armGroupLabels': ['Oxytocin + Ergot']}, {'name': 'Carboprost', 'type': 'DRUG', 'otherNames': ['Hemabate®'], 'description': 'Carboprost 0.25mg IM', 'armGroupLabels': ['Oxytocin + Carboprost']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', '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'}}}}