Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT03366259
Status:
UNKNOWN
Last Update Posted:
2017-12-11
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostaglandins Before Caserean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of intraoperative blood loss', 'timeFrame': 'during cesarean section', 'description': 'number of soaked towels'}, {'measure': 'postpartum hemorrhage', 'timeFrame': '24 hour after cesarean section', 'description': 'blood loss after cesarean section'}], 'secondaryOutcomes': [{'measure': 'fetal condition', 'timeFrame': '5 minutes after cesarean section', 'description': 'apgar score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrapartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss', 'detailedDescription': '160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:pregnant patients full term elective cesarean section\n\n\\-\n\nExclusion Criteria:\n\n* medical disorder with pregnancy'}, 'identificationModule': {'nctId': 'NCT03366259', 'briefTitle': 'Prostaglandins Before Caserean Section', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Does the Administration of Prostaglandins Before Cesarean Section Reduce the Amount of Blood Loss ?', 'orgStudyIdInfo': {'id': '4122017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Misoprostol group)', 'description': '200 mcg rectal Misoprostol administration before cesarean section', 'interventionNames': ['Drug: Misoprostol 200Mcg Tab', 'Procedure: elective cesarean section']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B (control group)', 'description': 'No prostaglandins administration before cesarean section', 'interventionNames': ['Procedure: elective cesarean section']}], 'interventions': [{'name': 'Misoprostol 200Mcg Tab', 'type': 'DRUG', 'description': 'administration of 200 Mcg of misoprotol rectal', 'armGroupLabels': ['Group A (Misoprostol group)']}, {'name': 'elective cesarean section', 'type': 'PROCEDURE', 'description': 'elective cesarean section for full term patients', 'armGroupLabels': ['Group A (Misoprostol group)', 'Group B (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr El Ainiy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics and gynecology', 'investigatorFullName': 'sarah mohamed hassan', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}