Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT05133167
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2021-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balloon Tamponade Vs B-Lynch In Placenta Previa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], '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': 'D010922', 'term': 'Placenta Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D021721', 'term': 'Balloon Occlusion'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D058450', 'term': 'Endotamponade'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D004621', 'term': 'Embolization, Therapeutic'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean blood loss', 'timeFrame': '24 hours post procedure', 'description': 'Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.', 'detailedDescription': 'After approval from hospital ethical committee, patients fulfilling the inclusion \\& exclusion criteria were recruited after taking informed written consent for surgery. Patients were allocated to group A and B using computer generated random sample allocation.\n\nIn group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters.\n\nIn group B, B-lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton pregnancy\n2. Late Third Trimester pregnancy (35+ weeks to 39 weeks)\n3. Placenta Previa confirmed by ultrasonography\n4. Elective Caesarean Section.\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Placenta accreta Spectrum (accrete/increta/percreta)\n3. Bleeding diathesis\n4. Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.\n5. Serious medical or surgical diseases.'}, 'identificationModule': {'nctId': 'NCT05133167', 'briefTitle': 'Balloon Tamponade Vs B-Lynch In Placenta Previa', 'organization': {'class': 'OTHER', 'fullName': 'CMH Jhelum'}, 'officialTitle': 'Comparison of Efficacy of Surgical Interventions (Balloon Tamponade Versus B-lynch Suture) to Prevent Postpartum Hemorrhage in Patients With Placenta Previa', 'orgStudyIdInfo': {'id': '16112021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A', 'description': 'In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.', 'interventionNames': ['Procedure: Balloon Tamponade or B-Lynch']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP B', 'description': 'In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.', 'interventionNames': ['Procedure: Balloon Tamponade or B-Lynch']}], 'interventions': [{'name': 'Balloon Tamponade or B-Lynch', 'type': 'PROCEDURE', 'description': 'In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.', 'armGroupLabels': ['GROUP A', 'GROUP B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49600', 'city': 'Jhelum', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'CMH', 'geoPoint': {'lat': 32.93448, 'lon': 73.73102}}], 'overallOfficials': [{'name': 'Muhammad Awais Qarni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will only share primary outcome result.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMH Jhelum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'M. Awais Qarni', 'investigatorAffiliation': 'CMH Jhelum'}}}}