Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06002256
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2023-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-12', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good hemostasis and achieving the uterus contracted', 'timeFrame': 'first 3 hours', 'description': 'no post-partum hemorrhage , we assess this by the amount of bleeding going down and by the atonic status of the uterus at that time'}, {'measure': 'obstetrician does not feel fatigued', 'timeFrame': 'during applying the maneuver', 'description': 'no exhaustion for the obstetrician , and this outcome is told by the investigators themselves'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mostafa Maged maneuver', 'Bimanual uterine compression', 'vaginal delivery', 'postpartum hemorrhage'], 'conditions': ['Post-partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal delivery.\n\nThe study subjects were categorized into two groups. The first group was managed by the Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine compression.\n\ninvestigators attempted to determine the duration of each maneuver required until the investigator became exhausted, as well as whether or not oxytocin was administered later in each maneuver .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Female pregnant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- female and pregnant\n\nExclusion Criteria:\n\n* hematological diseases morbid obese smoking'}, 'identificationModule': {'nctId': 'NCT06002256', 'briefTitle': 'Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health and Population, Egypt'}, 'officialTitle': 'Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage', 'orgStudyIdInfo': {'id': '(598 ) , Al-Azhar university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 : Mostafa Maged maneuver', 'description': 'The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)', 'interventionNames': ['Procedure: Mostafa Maged maneuver']}, {'type': 'OTHER', 'label': 'Group 2 : bimanual uterine compression', 'description': 'Both maneuver s are performed immediately after the delivery of the placenta and foetus, with no uterotonics administered at the onset of these maneuver s. In the event of atony after hand release due to fatigue, 5 IU of oxytocin is administered intravenously as uterotonics.\n\nthe clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.', 'interventionNames': ['Procedure: Bimanual uterine compression']}], 'interventions': [{'name': 'Mostafa Maged maneuver', 'type': 'PROCEDURE', 'description': 'While the patient is on the lithotomy position , The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)', 'armGroupLabels': ['Group 1 : Mostafa Maged maneuver']}, {'name': 'Bimanual uterine compression', 'type': 'PROCEDURE', 'description': 'the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.', 'armGroupLabels': ['Group 2 : bimanual uterine compression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0020', 'city': 'Cairo', 'state': 'Cairo and Fayoum', 'country': 'Egypt', 'facility': 'Fayoum general hospital and al azhar university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health and Population, Egypt', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mostafa Maged Ali', 'investigatorAffiliation': 'Ministry of Health and Population, Egypt'}}}}