Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 6:32 PM
Study NCT ID:
NCT05772156
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Methylergonovine for Twin Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'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': 'D008755', 'term': 'Methylergonovine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004874', 'term': 'Ergonovine'}, {'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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hbg2115@cumc.columbia.edu', 'phone': '877-843-2229', 'title': 'Intramuscular Methylergonovine to Decrease Blood Loss During Cesarean Delivery for Twins: A Triple-B', 'organization': 'NewYork-Presbyterian Hospital, Columbia University Irving Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'from enrollment until end of follow-up, up to 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal Saline 1mL', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maternal Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Postoperative Day 1 (Approximately 48 hours)', 'description': 'The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '75'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Surgical time measured from the time of incision to closure', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000', 'lowerLimit': '800', 'upperLimit': '900'}, {'value': '1000', 'groupId': 'OG001', 'lowerLimit': '800', 'upperLimit': '1098'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'At the end of the surgery, the primary surgeon will estimate the blood loss throughout the case.', 'unitOfMeasure': 'cc', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '891', 'groupId': 'OG000', 'lowerLimit': '743', 'upperLimit': '966'}, {'value': '1017', 'groupId': 'OG001', 'lowerLimit': '931', 'upperLimit': '1211'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Quantitative blood loss is calculated by weighing the used towels during the operation. The number is calculated by the circulating nurse in the operating room.', 'unitOfMeasure': 'cc', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postpartum Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'The number of participants with postpartum hemorrhage (defined as estimated blood loss \\>1000 cc)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Use of Uterotonics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants given uterotonics, such as prostaglandins', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Use of Tranexamic Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants given Tranexamic acid', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Use of Open-Label Methylergonovine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants requiring the use of any amount of open-label methylergonovine (not blinded study drug)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Transfusion (Intraoperative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants requiring transfusion of 1 or more units of packed red blood cells, including whole blood or cell saver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical or Radiological Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Composite number of surgical or radiological interventions (such as: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology) to control bleeding and related complications or maternal death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Transfusion Related Acute Lung Injury (TRALI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of participants with transfusion related acute lung injury (TRALI)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Transfusion (6 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of participants requiring transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Elevation of Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'Number of participants with acute elevation of serum creatinine of ≥ 0.3 mg/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Postpartum Infectious Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of Postpartum infectious complications such as: endometritis, surgical site infection, pelvic abscess', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Admission to the Intensive Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of participants with admission to the intensive care unit for more than 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 weeks', 'description': 'Length of stay measured from the time of hospital admission to hospital discharge.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Re-Admitted to the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'The number of participants who experienced hospital re-admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apgar Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'title': 'Apgar 1 minute', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '8'}]}]}, {'title': 'Apgar 5 minutes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '9'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 and 5 minutes post-delivery (approximately 24 hours post-baseline)', 'description': 'Apgar score is a measure of the physical condition of a newborn infant. Scores range from 0-10 with a higher score indicating a better outcome; Apgar score of 0-3 is low, 4-6 is moderately abnormal, and 7-10 is reassuring.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Newborns were assessed rather than the mothers (i.e. enrolled participants). Each participant gave birth to twins (66 newborns total). Newborns were not considered enrolled but did contribute to this assessment.'}, {'type': 'SECONDARY', 'title': 'Neonatal Intensive Care Unit (NICU) Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Normal Saline 1mL'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time of delivery (Approximately 24 hours)', 'description': 'Number of newborns admitted to the neonatal intensive care unit (NICU).', 'unitOfMeasure': 'newborns', 'reportingStatus': 'POSTED', 'populationDescription': 'Newborns were assessed rather than the mothers (i.e. enrolled participants). Each participant gave birth to twins (66 newborns total). Newborns were not considered enrolled but did contribute to this assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal Saline 1mL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prophylactic Methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal Saline 1mL'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Prior Cesarean Deliveries, n (%)', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=2', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chorionicity, n (%)', 'classes': [{'categories': [{'title': 'Dichorionic', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Monochorionic-Diamniotic', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal BMI (kg/m2), mean, SD', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '30.25', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tobacco use in pregnancy, n (%)', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational diabetes mellitus, n (%)', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative maternal hemoglobin level (g/dL), mean (SD)', 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '12.0', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '11.8', 'spread': '1.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-27', 'size': 171727, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-02T15:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2023-03-06', 'resultsFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maternal Hemoglobin Level', 'timeFrame': 'Baseline and Postoperative Day 1 (Approximately 48 hours)', 'description': 'The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.'}], 'secondaryOutcomes': [{'measure': 'Surgical Time', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Surgical time measured from the time of incision to closure'}, {'measure': 'Estimated Blood Loss', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'At the end of the surgery, the primary surgeon will estimate the blood loss throughout the case.'}, {'measure': 'Quantitative Blood Loss', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Quantitative blood loss is calculated by weighing the used towels during the operation. The number is calculated by the circulating nurse in the operating room.'}, {'measure': 'Number of Participants With Postpartum Hemorrhage', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'The number of participants with postpartum hemorrhage (defined as estimated blood loss \\>1000 cc)'}, {'measure': 'Number of Participants Requiring Use of Uterotonics', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants given uterotonics, such as prostaglandins'}, {'measure': 'Number of Participants Requiring Use of Tranexamic Acid', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants given Tranexamic acid'}, {'measure': 'Number of Participants Requiring Use of Open-Label Methylergonovine', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants requiring the use of any amount of open-label methylergonovine (not blinded study drug)'}, {'measure': 'Number of Participants Requiring Transfusion (Intraoperative)', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Number of participants requiring transfusion of 1 or more units of packed red blood cells, including whole blood or cell saver.'}, {'measure': 'Number of Participants With Surgical or Radiological Interventions', 'timeFrame': 'Intraoperative (Approximately 24 hours)', 'description': 'Composite number of surgical or radiological interventions (such as: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology) to control bleeding and related complications or maternal death.'}, {'measure': 'Number of Participants With Transfusion Related Acute Lung Injury (TRALI)', 'timeFrame': '6 weeks', 'description': 'Number of participants with transfusion related acute lung injury (TRALI)'}, {'measure': 'Number of Participants Requiring Transfusion (6 Weeks)', 'timeFrame': '6 weeks', 'description': 'Number of participants requiring transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates.'}, {'measure': 'Number of Participants With Acute Elevation of Serum Creatinine', 'timeFrame': '48 hours', 'description': 'Number of participants with acute elevation of serum creatinine of ≥ 0.3 mg/dL'}, {'measure': 'Number of Postpartum Infectious Complications', 'timeFrame': '6 weeks', 'description': 'Number of Postpartum infectious complications such as: endometritis, surgical site infection, pelvic abscess'}, {'measure': 'Number of Participants With Admission to the Intensive Care Unit', 'timeFrame': '6 weeks', 'description': 'Number of participants with admission to the intensive care unit for more than 24 hours'}, {'measure': 'Length of Stay', 'timeFrame': 'Up to 6 weeks', 'description': 'Length of stay measured from the time of hospital admission to hospital discharge.'}, {'measure': 'Number of Participants Re-Admitted to the Hospital', 'timeFrame': '6 weeks', 'description': 'The number of participants who experienced hospital re-admission'}, {'measure': 'Apgar Scores', 'timeFrame': '1 and 5 minutes post-delivery (approximately 24 hours post-baseline)', 'description': 'Apgar score is a measure of the physical condition of a newborn infant. Scores range from 0-10 with a higher score indicating a better outcome; Apgar score of 0-3 is low, 4-6 is moderately abnormal, and 7-10 is reassuring.'}, {'measure': 'Neonatal Intensive Care Unit (NICU) Admission', 'timeFrame': 'Time of delivery (Approximately 24 hours)', 'description': 'Number of newborns admitted to the neonatal intensive care unit (NICU).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Twin; Complicating Pregnancy', 'Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '35157571', 'type': 'BACKGROUND', 'citation': 'Osterman M, Hamilton B, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2020. Natl Vital Stat Rep. 2021 Feb;70(17):1-50.'}, {'pmid': '21807773', 'type': 'BACKGROUND', 'citation': 'Sheehan SR, Montgomery AA, Carey M, McAuliffe FM, Eogan M, Gleeson R, Geary M, Murphy DJ; ECSSIT Study Group. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011 Aug 1;343:d4661. doi: 10.1136/bmj.d4661.'}, {'pmid': '30836810', 'type': 'BACKGROUND', 'citation': 'Blitz MJ, Yukhayev A, Pachtman SL, Reisner J, Moses D, Sison CP, Greenberg M, Rochelson B. Twin pregnancy and risk of postpartum hemorrhage. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3740-3745. doi: 10.1080/14767058.2019.1583736. Epub 2019 Mar 5.'}, {'pmid': '20482535', 'type': 'BACKGROUND', 'citation': 'Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.'}, {'pmid': '20070961', 'type': 'BACKGROUND', 'citation': 'Chaudhuri P, Banerjee GB, Mandal A. Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss. Int J Gynaecol Obstet. 2010 Apr;109(1):25-9. doi: 10.1016/j.ijgo.2009.11.009. Epub 2010 Jan 13.'}, {'pmid': '26449959', 'type': 'BACKGROUND', 'citation': 'Senturk S, Kagitci M, Balik G, Arslan H, Kir Sahin F. The Effect of the Combined Use of Methylergonovine and Oxytocin during Caesarean Section in the Prevention of Post-partum Haemorrhage. Basic Clin Pharmacol Toxicol. 2016 May;118(5):338-43. doi: 10.1111/bcpt.12500. Epub 2015 Nov 15.'}, {'pmid': '35852267', 'type': 'BACKGROUND', 'citation': 'Masse N, Dexter F, Wong CA. Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):181-186. doi: 10.1097/AOG.0000000000004857. Epub 2022 Jul 6.'}, {'pmid': '14738165', 'type': 'BACKGROUND', 'citation': 'Horowitz E, Yogev Y, Ben-Haroush A, Rabinerson D, Feldberg D, Kaplan B. Routine hemoglobin testing following an elective Cesarean section: is it necessary? J Matern Fetal Neonatal Med. 2003 Oct;14(4):223-5. doi: 10.1080/jmf.14.4.223.225.'}]}, 'descriptionModule': {'briefSummary': 'Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery.\n\nThe purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.', 'detailedDescription': 'Obstetrical hemorrhage is a leading cause of maternal morbidity and mortality worldwide with a significantly higher frequency and severity following cesarean delivery. In 2020, 31.9 percent of pregnant women in the United States underwent cesarean delivery, making it the second most common operation performed. Though multiple complications can occur following cesarean delivery, hemorrhage morbidities are among the most common with significant cardiovascular implications. Twin gestations are at particularly higher risk for postpartum hemorrhage due to impaired myometrial contractility and atony following overdistention; increased maternal blood volume; and increased uterine blood flow compared to singletons, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery. Current strategies to address intrapartum hemorrhage have relied on pharmacological and mechanical treatments after intraoperative identification. However, there is extensive work on prophylactic therapies administered intraoperatively to prevent obstetrical hemorrhage. Recent evidence has emerged about the utility of prophylactic Methylergonovine for the prevention of obstetrical hemorrhage. Methylergonovine, a semisynthetic ergot alkaloid, acts primarily on alpha adrenergic receptors of uterine and vascular smooth muscle, increasing uterine tone and promoting vasoconstriction. In a randomized trial of 80 women undergoing intrapartum cesarean delivery found that fewer patients who were allocated to the methylergonovine group received additional uterotonic agents (20% vs 55%, relative risk (RR) 0.4, 95% confidence interval (CI) 0.2-0.6). Participants receiving methylergonovine were more likely to have satisfactory uterine tone (80% vs 41%, RR 1.9, 95% CI 1.5-2.6), lower incidence of postpartum hemorrhage (35% vs 59%, RR 0.6, 95% CI 0.4-0.9), lower mean quantitative blood loss (967 mL vs 1,315 mL; mean difference 348, 95% CI 124-572), and a lower frequency of blood transfusion (5% vs 23%, RR 0.2, 95% CI 0.1-0.6). Investigators concluded that the administration of prophylactic methylergonovine in addition to oxytocin in patients undergoing intrapartum cesarean birth reduces the need for additional uterotonic agents. In a prospective study of 1210 participants found that intraoperative, prophylactic methylergonovine decreased post-operative blood loss with no adverse side effects. Randomized trials of Methylergonovine as prophylaxis to prevent hemorrhage in cesarean delivery have exclude twin gestations. Currently, there remains a paucity of research regarding prophylactic procedures for twin cesarean delivery. There is an opportunity to prophylactically address hemorrhage in high-risk groups. Therefore, the investigators propose a prospective randomized controlled trial which will compare maternal blood loss associated with prophylactic methylergonovine during cesarean delivery among patients with twin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Twin gestation\n* Scheduled cesarean delivery (\\>=34 weeks)\n\nExclusion criteria:\n\n* Patients with known hypertensive disease: history of chronic hypertension, gestational hypertension or preeclampsia with or without severe features\n* Use of protease inhibitors given known vasoconstrictive side effects with concomitant methylergonovine administration\n* Hypersensitivity to methylergonovine or any of the ingredients\n* Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism\n* Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis\n* Non-elective cesarean delivery'}, 'identificationModule': {'nctId': 'NCT05772156', 'briefTitle': 'Prophylactic Methylergonovine for Twin Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Prophylactic Methylergonovine in Patients Undergoing Cesarean Delivery With Twin Gestations: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AAAU3902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prophylactic methylergonovine', 'description': 'Prophylactic methylergonovine 200mcg IM', 'interventionNames': ['Drug: Methylergonovine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group/placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methylergonovine', 'type': 'DRUG', 'otherNames': ['Methergine'], 'description': 'Methylergonovine 200mcg Intramuscular (IM)', 'armGroupLabels': ['Prophylactic methylergonovine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Matching saline placebo', 'armGroupLabels': ['Control group/placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mirella Mourad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is currently undecided if the Individual participant data (IPD) will be shared.\n\nIf there is a plan to share the following will be shared: the IPD that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), the Study Protocol, Statistical Analysis Plan, and, Informed Consent Form documents. The timeframe for which the IPD will be shared is beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal, so that they may achieve aims in the proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Mirella Mourad', 'investigatorAffiliation': 'Columbia University'}}}}