Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03870256
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2019-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'C020731', 'term': 'carbetocin'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study was a prospective double-blind randomized study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was a prospective double-blind randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the amount of blood loss', 'timeFrame': '6 hours post delivery', 'description': 'the amount of blood loss by gm calculated by gravimetric methods'}], 'secondaryOutcomes': [{'measure': 'number of patients loss more than 1000 ml blood', 'timeFrame': '24 hours post delivery', 'description': 'calculate number of patients loss more than 1000 ml blood'}, {'measure': 'need of uterotonics', 'timeFrame': '24 hours post delivery', 'description': 'number of patients need of uterotonics'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum Hemorrhage', 'vaginal delivery', 'tranexamic acid', 'misoprostol'], 'conditions': ['Post Partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery', 'detailedDescription': 'Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'All participants had PPH defined as vaginal bleeding\\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants had PPH defined as vaginal bleeding\\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.\n\nExclusion Criteria:\n\n* were gestational age\\<37 weeks,\n* genital tract trauma,\n* coagulation defect,\n* women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy\n* known hypersensitivity to carbetocin or oxytocin.'}, 'identificationModule': {'nctId': 'NCT03870256', 'briefTitle': 'Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/200/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TA plus misoprostol', 'description': 'Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm', 'interventionNames': ['Drug: misoprostol', 'Drug: TA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbetocin', 'description': 'Patient receives 100 mic gm carbetocin IV', 'interventionNames': ['Drug: Carbetocin']}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'otherNames': ['Active comparator'], 'description': 'Patient receive 600mic gm sublingual misoprostol', 'armGroupLabels': ['TA plus misoprostol']}, {'name': 'Carbetocin', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'Patient receive 100 mic gm carbetocin IV', 'armGroupLabels': ['Carbetocin']}, {'name': 'TA', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'The patient receives 1gm oral tranexamic acid', 'armGroupLabels': ['TA plus misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'AswanUH', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'hany f allam, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}