Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT04201951
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2019-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women
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': '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'All providers and delivered women will be blinded for the content of the bags which will be applied for women randomly'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2019-12-14', 'studyFirstSubmitQcDate': '2019-12-14', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)', 'timeFrame': 'From the time of injection and up to 2 hours after delivery', 'description': 'The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use)'}], 'secondaryOutcomes': [{'measure': 'Number of participant with Post Partum Hemorrhage', 'timeFrame': 'up to 2 hours after delivery', 'description': 'Vaginal blood loss of more than 500 mL'}, {'measure': 'Number of participant with severe postpartum hemorrhage', 'timeFrame': 'up to 2 hours after delivery', 'description': 'Vaginal blood loss ≥1000mL'}, {'measure': 'Number of participant who will need additional uterotonic drugs to control blood loss', 'timeFrame': 'up to 2 hours after delivery', 'description': 'Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally'}, {'measure': 'the mean length of third stage of labor in both groups', 'timeFrame': 'up to 30 minutes', 'description': 'time from injection of the intervention and placebo group till the delivery of placenta'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage', 'High Risk Pregnancy', 'Tranexamic Acid', 'Third-Stage Postpartum Hemorrhage, With Delivery']}, 'descriptionModule': {'briefSummary': 'Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage', 'detailedDescription': 'Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.\n\nA Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 year.\n* Planed vaginal delivery\n* Grand multiparity\n* Twin pregnancy\n* Polyhydramnios\n* Previous history of PPH\n* Macrosomic baby\n* Prolonged labour\n* HELLP syndrome\n* Using of low-molecular weight heparin and Asprin during pregnancy.\n* Vaginal birth after Cesarean section\n\nExclusion Criteria:\n\n* Intrauterine death.\n* History of thromboembolic disease\n* Current or previous history of heart disease ,renal and liver disorders\n* History of seizure or epilepsy\n* Placenta previa\n* Placental abruptio'}, 'identificationModule': {'nctId': 'NCT04201951', 'briefTitle': 'Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': 'Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HawlerMU3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic group', 'description': 'Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water', 'interventionNames': ['Drug: Tranexamic acid injection', 'Other: Glucose water 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Group B will receive 30ML 5% glucose water', 'interventionNames': ['Drug: Tranexamic acid injection', 'Other: Glucose water 5%']}], 'interventions': [{'name': 'Tranexamic acid injection', 'type': 'DRUG', 'otherNames': ['TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India'], 'description': 'Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus', 'armGroupLabels': ['Placebo group', 'Tranexamic group']}, {'name': 'Glucose water 5%', 'type': 'OTHER', 'otherNames': ['Glucose B.Braun 50 mg/mL'], 'description': 'Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus', 'armGroupLabels': ['Placebo group', 'Tranexamic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44001', 'city': 'Erbil', 'state': 'Kurdistan Region', 'country': 'Iraq', 'facility': 'Kurdistan Board for Medical speciality', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}, {'zip': '44001', 'city': 'Erbil', 'state': 'Kurdistan Region', 'country': 'Iraq', 'facility': 'Maternity Teaching Hospital', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}], 'overallOfficials': [{'name': 'Shahla K. Alalaf, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hawler Medical University'}, {'name': 'Sazgar A. Rashid, FIBOG', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministery of Health'}, {'name': 'Chro S. Hassan, MBChB', 'role': 'STUDY_CHAIR', 'affiliation': 'Kurdistan Board for Medical Speciality'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hawler Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shahla Alalaf', 'investigatorAffiliation': 'Hawler Medical University'}}}}