{ "FullStudy":{ "Rank":218265, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510574", "OrgStudyIdInfo":{ "OrgStudyId":"3002" }, "Organization":{ "OrgFullName":"Gynuity Health Projects", "OrgClass":"OTHER" }, "BriefTitle":"A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)" }, "StatusModule":{ "StatusVerifiedDate":"March 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 4, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 11, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 13, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Gynuity Health Projects", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"University of Liverpool", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Liverpool School of Tropical Medicine", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Makerere University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Mbale Regional Referral Hospital", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.\n\nThe investigators envisage that the use of self administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).\n\nThe objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Postpartum Hemorrhage" ] }, "KeywordList":{ "Keyword":[ "postpartum hemorrhage, PPH, misoprostol" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"749", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"misoprostol", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Misoprostol" ] } },{ "ArmGroupLabel":"placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Misoprostol", "InterventionDescription":"3 x 200mcg tablets of oral misoprostol", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "misoprostol" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"3 x placebo tablets resembling misoprostol taken orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in hemoglobin", "PrimaryOutcomeDescription":"Peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot) following use of self-administered misoprostol after home birth", "PrimaryOutcomeTimeFrame":"Measured during third trimester and 3-5 days postpartum" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Safety", "SecondaryOutcomeDescription":"To assess the safety of ante-natal distribution of misoprostol and its use by women at the time of their home birth, data will be collected on the number of women who report experiencing side effects (including shivering and fever), number of women who are transferred to higher level care, number of women who undergo surgical interventions, number of women who are given blood transfusions, number of maternal deaths, and number of neonatal deaths.\n\nThe exact outcomes as well as the power calculations will only be finalized once the pilot study is completed.", "SecondaryOutcomeTimeFrame":"Assessed 3-5 days postpartum" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\npregnant women living in the recruitment villages of Mbale district at >34 weeks gestation\n\nExclusion Criteria:\n\nAny woman with a known allergy to misoprostol or other prostaglandins will be excluded as will any woman under 18 years old (unless she is an emancipated minor)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Andrew Weeks", "OverallOfficialAffiliation":"University of Liverpool", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Busiu Health Centre", "LocationCity":"Mbale", "LocationCountry":"Uganda" },{ "LocationFacility":"Lwangoli Health Centre", "LocationCity":"Mbale", "LocationCountry":"Uganda" },{ "LocationFacility":"Mbale Regional Referral Hospital", "LocationCity":"Mbale", "LocationCountry":"Uganda" },{ "LocationFacility":"Siira Health Centre", "LocationCity":"Mbale", "LocationCountry":"Uganda" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000016595", "InterventionMeshTerm":"Misoprostol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000020", "InterventionAncestorTerm":"Abortifacient Agents, Nonsteroidal" },{ "InterventionAncestorId":"D000000019", "InterventionAncestorTerm":"Abortifacient Agents" },{ "InterventionAncestorId":"D000012102", "InterventionAncestorTerm":"Reproductive Control Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000897", "InterventionAncestorTerm":"Anti-Ulcer Agents" },{ "InterventionAncestorId":"D000005765", "InterventionAncestorTerm":"Gastrointestinal Agents" },{ "InterventionAncestorId":"D000010120", "InterventionAncestorTerm":"Oxytocics" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M17562", "InterventionBrowseLeafName":"Misoprostol", "InterventionBrowseLeafAsFound":"Misoprostol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2769", "InterventionBrowseLeafName":"Antacids", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2800", "InterventionBrowseLeafName":"Anti-Ulcer Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7464", "InterventionBrowseLeafName":"Gastrointestinal Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Gast", "InterventionBrowseBranchName":"Gastrointestinal Agents" },{ "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006473", "ConditionMeshTerm":"Postpartum Hemorrhage" },{ "ConditionMeshId":"D000006470", "ConditionMeshTerm":"Hemorrhage" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000007744", "ConditionAncestorTerm":"Obstetric Labor Complications" },{ "ConditionAncestorId":"D000011248", "ConditionAncestorTerm":"Pregnancy Complications" },{ "ConditionAncestorId":"D000011644", "ConditionAncestorTerm":"Puerperal Disorders" },{ "ConditionAncestorId":"D000014592", "ConditionAncestorTerm":"Uterine Hemorrhage" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8139", "ConditionBrowseLeafName":"Hemorrhage", "ConditionBrowseLeafAsFound":"Hemorrhage", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8142", "ConditionBrowseLeafName":"Postpartum Hemorrhage", "ConditionBrowseLeafAsFound":"Postpartum Hemorrhage", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9347", "ConditionBrowseLeafName":"Obstetric Labor Complications", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12710", "ConditionBrowseLeafName":"Pregnancy Complications", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13082", "ConditionBrowseLeafName":"Puerperal Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15923", "ConditionBrowseLeafName":"Uterine Hemorrhage", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" } ] } } } } } }