Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT05759156
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Patients for Caesarian Delivery.
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 572}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of postpartum haemorrhage (PPH)', 'timeFrame': 'up to 2 days'}, {'measure': 'Obstetrics quality of recovery (ObsQoR) score', 'timeFrame': 'at 2 days'}], 'secondaryOutcomes': [{'measure': 'Measurement of postpartum blood loss', 'timeFrame': 'at 2 days'}, {'measure': 'Operative time', 'timeFrame': 'up to 3 hours'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 4 days'}, {'measure': 'Frequency of emergency surgery for postpartum haemorrhage', 'timeFrame': 'up to 12 hours'}, {'measure': 'Rate of ICU transfer', 'timeFrame': 'up to 1 day'}, {'measure': 'Rate of Maternal death', 'timeFrame': 'up to 3 months'}, {'measure': 'Adverse events related to tranexamic acid', 'timeFrame': 'up to 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caesarian delivery', 'postpartum haemorrhage', 'obstetrics quality of recovery', 'tranexamic acid'], 'conditions': ['Postpartum Hemorrhage', 'Cesarean Section Complications', 'Obstetric Anesthesia Problems']}, 'descriptionModule': {'briefSummary': 'This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria will include:\n\n1. Informed consent of the participant\n2. All women who are 18 years old or above\n3. Gestational age equal or above 34 weeks\n4. Women undergoing emergency or elective CD\n5. Complete blood count (CBC) within seven days before the CD\n\nExclusion Criteria:\n\nThe exclusion criteria will include:\n\n1. Women with thromboembolic or bleeding incidents in the past\n2. Hypersensitivity to TXA\n3. History of epilepsy or seizure\n4. Women with abnormal placenta including accreta, increta or percreta\n5. Any active cardiovascular, renal, or liver disorders\n6. Autoimmune disorders\n7. Sickle cell disease\n8. Placenta Previa\n9. Abruptio Placentae\n10. Eclampsia or HELLP syndrome\n11. Women who might undergo intraoperative complications.'}, 'identificationModule': {'nctId': 'NCT05759156', 'acronym': 'TXA; CD', 'briefTitle': 'Tranexamic Acid in Patients for Caesarian Delivery.', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).', 'orgStudyIdInfo': {'id': '2891'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic Acid', 'interventionNames': ['Drug: Tranexamic acid injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'interventionNames': ['Drug: Tranexamic acid injection']}], 'interventions': [{'name': 'Tranexamic acid injection', 'type': 'DRUG', 'description': 'The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.', 'armGroupLabels': ['Normal Saline', 'Tranexamic Acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'DowUHS', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Atif Shafqat', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}