Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03505502
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients were randomized to three groups, each compromised of thirty-five patients according to a three-blocked randomization list which was coded (1 or 2 or 3) at 1:1:1 ratio. The three parallel groups were prepared using a Computer-generated randomization system. The allocated groups will be concealed in serially numbered sealed opaque envelopes that will only be opened after recruitment. The patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a double-blinded randomized placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2018-04-07', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'estimation of intraoperative blood loss (ml).', 'timeFrame': 'intraoperative', 'description': 'Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding'}], 'secondaryOutcomes': [{'measure': 'need for blood transfusion', 'timeFrame': '24 hours postoperative', 'description': 'need for blood transfusion'}, {'measure': 'Hemoglobin concentration', 'timeFrame': 'ist 24 hours postoperative', 'description': 'pre and postoperative hemoglobin estimation'}, {'measure': 'operative time', 'timeFrame': 'operative time', 'description': 'operative time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Myomectomy', 'Tranexamic Acid'], 'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'This study was a double-blinded randomized controlled study conducted at Aswan University, Egypt from January 2018 to January 2020. Study inclusion criteria were women who attended the outpatient obstetric clinic, seeking antenatal care diagnosed with leiomyomas with pregnancy and with myoma staging from (3 to 6) according to FIGO staging. scheduled to undergo cesarean myomectomy (11) Exclusion criteria were: 1-Patients undergone vaginal delivery.2-Patients with a history of thromboembolic disease. 3-Cervical and broad ligament myoma. 4-Myoma FIGO staging', 'detailedDescription': 'Eligible participants were allocated to one of two groups after induction of anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal salines) by slow intravenous injection at an approximate rate of 1 mL per min. The abdomen was exposed through a midline or Pfannenstiel incision, after skin incision, the subcutaneous fat and abdominal fascia were opened crosswise, and the rectus muscle was opened on the midline. The parietal peritoneum was opened longitudinally to reach the pelvic cavity. Uterus was inspected for a number, location, and shape of myomas and other pelvic organs were inspected for associated pathology. a lower uterine incision will be performed to deliver the baby and Uterine incisions on top of myoma were performed. The incision was performed using monopolar diathermy. Intracapsular enucleation of myomas was performed by gently dissecting between the myoma and the pseudo-capsule. The myoma was grasped by Collins forceps and gently enucleated out.,. Myoma bed was closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). At the end of the surgery, 1 intraperitoneal suction drain was routinely used in all patients the drains were removed on the second postoperative day unless otherwise indicated. Number and size of myomas were recorded. Myoma size represented the mean size of each myoma. Enucleated myomas were sent to histopathology.\n\nBlood loss estimation Intraoperative blood loss was measured by adding the volume of the contents of the suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'women who attended the outpatient obstetric clinic, seeking antenatal care diagnosed with leiomyomas with pregnancy and with myoma staging from (3 to 6) according to FIGO staging. scheduled to undergo cesarean myomectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who attended the outpatient gynecology clinic, seeking treatment for symptomatic leiomyomas and scheduled to undergo abdominal myomectomy with myoma staging from (3 to 6) according to FIGO staging\n\nExclusion Criteria:\n\n1. Patients undergone vaginal or laparoscopic myomectomy.\n2. Patients received preoperative embolization or gonadotrophin releasing hormone analog.\n3. Cervical and broad ligament myoma.\n4. Patients with cardiac, hepatic, renal or thromboembolic disease\n5. patients had an allergy to tranexamic acid).'}, 'identificationModule': {'nctId': 'NCT03505502', 'acronym': 'TA', 'briefTitle': 'Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Reducing Blood Loss During Cesarean Myomectomy With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/203/2/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo arm', 'description': 'group receive i/v saline plus irrigation of the myoma bed with normal saline', 'interventionNames': ['Drug: IV tranexamic acid']}, {'type': 'EXPERIMENTAL', 'label': 'IV tranexamic acid group', 'description': 'group received IV tranexamic 1gm in normal saline', 'interventionNames': ['Drug: IV tranexamic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'topical tranexamic acid group', 'description': 'group received topical tranexamic 2gm in normal saline', 'interventionNames': ['Drug: IV tranexamic acid']}], 'interventions': [{'name': 'IV tranexamic acid', 'type': 'DRUG', 'otherNames': ['Topical tranexamic acid'], 'description': 'in IV tranexamic acid group they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min.In topical tranexamic acid groupA gauze soaked with 2g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) used to compress the myoma bed for 5 minutes. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.', 'armGroupLabels': ['IV tranexamic acid group', 'placebo arm', 'topical tranexamic acid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'AswanUH', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}, {'city': 'Aswān', 'country': 'Egypt', 'facility': 'AswanUH', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}