Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-22 @ 7:51 PM
Study NCT ID:
NCT02660567
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2016-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amr's Maneuver and Postpartum 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of postpartum hemorrhage', 'timeFrame': '24 hour', 'description': "the incidence of post partum hemorrhage (PPH\\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postpartum hemorrhage', 'PPH', 'atonic', 'new maneuver'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '32609374', 'type': 'DERIVED', 'citation': 'Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.'}, {'pmid': '30281778', 'type': 'DERIVED', 'citation': "Hamdy A, Azmy O, Lotfy R, Attia AA, Elsherbini MM, Al Sawaf A, Soliman MM, Sharaf MF, Kamel A, Abd El-Raouf MN, Salem S, Rasheed MA, Torky H, Issak ER. Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jan;144(1):56-61. doi: 10.1002/ijgo.12687. Epub 2018 Oct 22."}]}, 'descriptionModule': {'briefSummary': "The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH\\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone", 'detailedDescription': "Primary:\n\nCompare the incidence of post partum hemorrhage (PPH\\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone\n\nSecondary:\n\nComparing:\n\n* The amount of blood loss in each arm of the study\n* Hematocrit before and after labor\n* Duration from delivery of placenta till discharge from the delivery room"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All pregnant females aged 18 years or more, candidate for normal vaginal delivery during the period of the study will be included\n\nExclusion Criteria:\n\n* Women presenting with pre-existing maternal hemorrhagic conditions such as factor 8 or 9 deficiency or Von Willebrand's disease or those who had assisted vaginal delivery"}, 'identificationModule': {'nctId': 'NCT02660567', 'briefTitle': "Amr's Maneuver and Postpartum Hemorrhage", 'organization': {'class': 'OTHER', 'fullName': 'ClinAmygate'}, 'officialTitle': "The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study", 'orgStudyIdInfo': {'id': '15127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amr Maneuver', 'description': "Active management of third stage plus Amr's maneuver", 'interventionNames': ['Procedure: Amr maneuver']}, {'type': 'NO_INTERVENTION', 'label': 'Active management alone', 'description': 'Active management of third stage alone'}], 'interventions': [{'name': 'Amr maneuver', 'type': 'PROCEDURE', 'description': 'sustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds', 'armGroupLabels': ['Amr Maneuver']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo University Hospitals (Kasr Al-Aini)', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Osama Azmy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Egypt National Research Centre Reproductive Health Research Department'}, {'name': 'Emad RH Issak, DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ClinAmygate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ClinAmygate', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'Ain Shams University', 'class': 'OTHER'}, {'name': 'October 6 University', 'class': 'OTHER'}, {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}