Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:50 PM
Study NCT ID:
NCT07423156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid vs Vasopressin in Placenta Previa Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], '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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel two-arm randomized controlled trial. Eligible participants will be randomly allocated into two groups (1:1). Group A will receive intravenous tranexamic acid 1 g pre-operatively, and Group B will receive local vasopressin 4 units at placental implantation site after delivery of placenta.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Blood Loss', 'timeFrame': 'Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.', 'description': 'Total estimated blood loss during cesarean section measured using the per-operative visual assessment method (gauze saturation method) plus the amount of blood collected in the suction drain.'}], 'secondaryOutcomes': [{'measure': 'Need for Blood Transfusion', 'timeFrame': 'Assessed within the immediate postoperative period (after surgery).', 'description': 'Requirement of blood transfusion if postoperative hemoglobin is \\< 9 g/dL.'}, {'measure': 'Drug Efficacy', 'timeFrame': 'Assessed intraoperatively at completion of surgery.', 'description': 'Drug will be considered efficacious if estimated intraoperative blood loss is ≤ 500 mL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstetric Hemorrhage', 'Cesarean Section', 'Tranexamic Acid', 'Vasopressin'], 'conditions': ['Placenta Previa']}, 'referencesModule': {'references': [{'pmid': '24750470', 'type': 'BACKGROUND', 'citation': 'Kato S, Tanabe A, Kanki K, Suzuki Y, Sano T, Tanaka K, Fujita D, Terai Y, Kamegai H, Ohmichi M. Local injection of vasopressin reduces the blood loss during cesarean section in placenta previa. J Obstet Gynaecol Res. 2014 May;40(5):1249-56. doi: 10.1111/jog.12356. Epub 2014 Apr 21.'}, {'pmid': '35287618', 'type': 'BACKGROUND', 'citation': 'Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4.'}]}, 'descriptionModule': {'briefSummary': 'Placenta previa is a major obstetric condition associated with increased risk of excessive blood loss during cesarean section, leading to maternal morbidity and mortality. Different pharmacological agents have been used to minimize intraoperative hemorrhage. Tranexamic acid is an antifibrinolytic agent, while vasopressin reduces blood loss by causing vasoconstriction and myometrial contraction at the injection site. Both drugs have been used separately in placenta previa cases, however direct comparison between tranexamic acid and vasopressin is limited.\n\nThis randomized controlled trial will be conducted at the Department of Obstetrics \\& Gynecology, AIMC/Jinnah Hospital Lahore. A total of 58 women (29 in each group), aged 18-45 years, with singleton pregnancy and diagnosed placenta previa undergoing elective cesarean section will be included. Participants will be randomly allocated into two groups. Group A will receive 1 gram tranexamic acid diluted in 20 ml of 5% dextrose intravenously 15 minutes before cesarean section. Group B will receive 4 units vasopressin diluted in 20 ml normal saline injected at placental implantation site after delivery of placenta.\n\nThe primary outcome will be intraoperative blood loss measured by gauze saturation assessment and suction drain measurement. The study will help determine which drug is more effective in reducing blood loss in placenta previa patients undergoing cesarean section.', 'detailedDescription': 'This study is a randomized controlled trial designed to compare the efficacy of tranexamic acid versus vasopressin in reducing intraoperative blood loss among patients with placenta previa undergoing elective cesarean section. The study will be conducted in the Department of Obstetrics \\& Gynecology, Allama Iqbal Medical College (AIMC)/Jinnah Hospital, Lahore, over a maximum duration of 12 months after approval of synopsis.\n\nA total sample size of 58 patients will be enrolled through non-probability purposive sampling. Women aged 18-45 years with singleton pregnancy and placenta previa scheduled for elective cesarean section will be included. Patients undergoing emergency cesarean section, having coagulation disorders, chronic liver/kidney disease, gestational diabetes, hypertensive disorders of pregnancy, history of postpartum hemorrhage, or using anticoagulant/antiplatelet drugs will be excluded.\n\nAfter informed consent, baseline characteristics including age, gravida, para, abortion history, grade of placenta previa, and pre-operative hemoglobin will be recorded. Patients will be randomized into two groups using paper lottery method.\n\nGroup A will receive injection tranexamic acid 1 gram diluted in 20 ml of 5% dextrose administered intravenously 15 minutes before cesarean section. Group B will receive injection vasopressin 4 units diluted in 20 ml normal saline injected at placental implantation site after delivery of placenta. Both groups will receive standard uterotonic management with oxytocin 40 units in 500 ml of 5% glucose solution.\n\nBlood loss will be assessed intraoperatively using visual gauze saturation method and suction drain volume. Post-operative hematocrit will be measured after achieving hemostasis and closure. Data will be analyzed using SPSS(statistical package of social sciences) version 26. Quantitative variables will be expressed as mean ± standard deviation and categorical variables as frequency and percentage. Independent sample t-test or Mann Whitney U test will be applied for comparison of quantitative variables, and Chi-square test for categorical variables. Stratification will be done for age and grade of placenta previa. A p-value ≤ 0.05 will be considered statistically significant.\n\nThe findings will help identify which intervention is more effective and safer for reducing intraoperative blood loss in placenta previa patients undergoing cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study includes women of reproductive age (18-45 years) with placenta previa undergoing elective cesarean section.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen of reproductive age\n\nAge 18-45 years\n\nDiagnosed placenta previa in current pregnancy\n\nScheduled for elective cesarean section\n\nSingleton pregnancy\n\nExclusion Criteria:\n\nEmergency cesarean section\n\nPlatelet or coagulation disorder\n\nUse of anti-platelet or anti-coagulant drugs\n\nPrevious history of postpartum hemorrhage\n\nChronic liver disease\n\nChronic kidney disease\n\nGestational diabetes\n\nPregnancy-related hypertensive disorders\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07423156', 'acronym': 'TXA-VASO-PP', 'briefTitle': 'Tranexamic Acid vs Vasopressin in Placenta Previa Trial', 'organization': {'class': 'OTHER', 'fullName': 'Allama Iqbal Medical College'}, 'officialTitle': 'Comparison of Efficacy of Tranexamic Acid Versus Vasopressin in Blood Loss Among Placenta Previa Patients Undergoing Cesarean Section', 'orgStudyIdInfo': {'id': 'No 17 CMD/AIMC'}, 'secondaryIdInfos': [{'id': 'CNIC No.: 32103-9070878-6', 'type': 'OTHER_GRANT', 'domain': 'Allama Iqbal Medical College Lahore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid (TXA) Group', 'description': 'Arm 1: Tranexamic Acid Group (TXA Group) Number of participants: 29 Description: Patients with placenta previa undergoing elective cesarean section receiving tranexamic acid prophylactically before surgery', 'interventionNames': ['Drug: Group A: Tranexamic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Vasopressin Group', 'description': 'Arm 2: Vasopressin Group Number of participants: 29 Description: Patients with placenta previa undergoing elective cesarean section receiving vasopressin prophylactically.', 'interventionNames': ['Drug: Group B: Vasopressin']}], 'interventions': [{'name': 'Group A: Tranexamic acid', 'type': 'DRUG', 'otherNames': ['Inj Transamin 1gm'], 'description': 'Injection Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section.\n\n(prophylactically)', 'armGroupLabels': ['Tranexamic Acid (TXA) Group']}, {'name': 'Group B: Vasopressin', 'type': 'DRUG', 'otherNames': ['Novapressin'], 'description': 'Injection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta.', 'armGroupLabels': ['Vasopressin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+92', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'SHAZIA SAAQIB, FCPS, MCPS', 'role': 'CONTACT', 'email': 'shaziasaaqib@gmail.com', 'phone': '0923214708583'}, {'name': 'Aimen Sattar, MBBS', 'role': 'CONTACT', 'email': 'aimansattar7@gmail.com', 'phone': '+923190658053'}], 'facility': 'Jinnah Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Shazia Saaqib, FCPS,MCPS', 'role': 'CONTACT', 'email': 'shaziasaaqib@gmail.com', 'phone': '+923214708583'}, {'name': 'Aimen Sattar, MBBS', 'role': 'CONTACT', 'email': 'aimansattar7@gmail.com', 'phone': '+923190658053'}], 'overallOfficials': [{'name': 'Aiman Sattar, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinnah Hospital/AIMC/UHS'}, {'name': 'Shazia Saaqib, FCPS,MCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinnah Hospital/AIMC/UHS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared publicly to maintain patient confidentiality and privacy. The study involves sensitive clinical and obstetric information, and no personal identifiers will be disclosed. Data may be made available upon reasonable request to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allama Iqbal Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}