Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-07-21 @ 4:01 AM
Study NCT ID:
NCT02509351
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?
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': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, 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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'volume of intraoperative blood loss', 'timeFrame': '30 minute', 'description': 'volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor'}], 'secondaryOutcomes': [{'measure': 'maternal mortality', 'timeFrame': '6 months'}, {'measure': 'mean measured blood loss', 'timeFrame': '1, 2, and 24 h postpartum'}, {'measure': 'placental retention', 'timeFrame': '30 minutes', 'description': 'when the placenta is not delivered spontaneously for 30 minutes'}, {'measure': 'requirement for blood transfusion', 'timeFrame': '24 hours', 'description': 'indicated per clinical protocol at the study site for mothers with a hemoglobin \\<100 g/l and/or severe pallor'}, {'measure': 'requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures', 'timeFrame': '24 hours'}, {'measure': 'postpartum hemoglobin', 'timeFrame': '24 hours', 'description': 'less than 10gm%'}, {'measure': 'mean postpartum hematocrit', 'timeFrame': '24 hours', 'description': 'more than 10% drop in the postpartum hematocrit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postpartum Haemorrhage']}, 'descriptionModule': {'briefSummary': "* Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.\n* The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin", 'detailedDescription': "Research question:\n\nIn women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?\n\nResearch hypothesis:\n\npre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 38-41 weeks of amenorrhea\n* scheduled for elective lower segment cesarean section\n\nExclusion Criteria:\n\n* confirmed intrauterine fetal death\n* more than previous 2 ceserean sections\n* multiple pregnancy\n* antepartum haemorrhage\n* self-reported maternal heart disease\n* current diagnosis of severe malaria or acute bacterial infection'}, 'identificationModule': {'nctId': 'NCT02509351', 'briefTitle': 'Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section', 'orgStudyIdInfo': {'id': 'POMCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'misoprostol', 'description': 'women receiving pre-operative rectally administered 400 microgram misoprostol', 'interventionNames': ['Drug: misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placeboo', 'description': 'women receiving placebo', 'interventionNames': ['Drug: placeboo']}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'otherNames': ['mesotac'], 'description': '400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section', 'armGroupLabels': ['misoprostol']}, {'name': 'placeboo', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'women will recive 2 identical tablets as placeboo', 'armGroupLabels': ['placeboo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Helmy Dr metawe, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ahmed Mohamed El Kotb Abdel Fattah', 'investigatorAffiliation': 'Ain Shams University'}}}}