Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT00186069
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Magnesium Sulfate vs Placebo for Placental Abruption
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000037', 'term': 'Abruptio Placentae'}], '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': 'D010922', 'term': 'Placenta Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agirsen@stanford.edu', 'phone': '(650) 725-5720', 'title': 'Anna Girsen, Manager of Research Operations', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.', 'eventGroups': [{'id': 'EG000', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour\n\nMagnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour\n\nNormal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour\n\nMagnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour\n\nNormal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.86', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 hours after the randomization', 'description': 'The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gestational Age at Delivery (Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour\n\nMagnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour\n\nNormal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '38'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '39'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Time of delivery', 'description': 'Median gestational age at delivery (in full weeks)', 'unitOfMeasure': 'weeks of gestation', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Apgar Score at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour\n\nMagnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour\n\nNormal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '9'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 5 minutes after birth', 'description': 'The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.', 'unitOfMeasure': 'Apgar score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour\n\nMagnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.'}, {'id': 'FG001', 'title': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour\n\nNormal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrollment goal was not reached due to the introduction of magnesium sulfate for neuroprotection', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Enrollment goal was not reached due to the introduction of magnesium sulfate for neuroprotection', 'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour\n\nMagnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.'}, {'id': 'BG001', 'title': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour\n\nNormal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '27.8', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'title': 'Nulliparous', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Multiparous', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of women who were nulliparous at enrollment', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age at randomization (weeks)', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '32'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '31'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks of gestation', 'dispersionType': 'FULL_RANGE'}, {'title': 'Placental location', 'classes': [{'title': 'Anterior', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Posterior', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Fundal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Lateral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Vaginal bleeding before study drug administered', 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-01', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-09', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours', 'timeFrame': '48 hours after the randomization', 'description': 'The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.'}], 'secondaryOutcomes': [{'measure': 'Gestational Age at Delivery (Weeks)', 'timeFrame': 'Time of delivery', 'description': 'Median gestational age at delivery (in full weeks)'}, {'measure': 'Neonatal Apgar Score at 5 Minutes', 'timeFrame': 'At 5 minutes after birth', 'description': 'The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abruptio Placentae']}, 'referencesModule': {'references': [{'pmid': '26871905', 'type': 'DERIVED', 'citation': 'Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.', 'detailedDescription': 'We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.\n\nExclusion Criteria:\n\n\\- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress'}, 'identificationModule': {'nctId': 'NCT00186069', 'briefTitle': 'Magnesium Sulfate vs Placebo for Placental Abruption', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption', 'orgStudyIdInfo': {'id': '79811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal Saline 4 gram bolus, followed by 2 grams per hour', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'otherNames': ['Active study drug'], 'description': 'Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.', 'armGroupLabels': ['Magnesium Sulfate']}, {'name': 'Normal Saline', 'type': 'OTHER', 'otherNames': ['Normal Saline infusion as placebo'], 'description': 'Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Yasser Y El-Sayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Santa Clara Valley Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Yasser Yehia El-Sayed', 'investigatorAffiliation': 'Stanford University'}}}}