Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial

HawlerMU5

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

2022-01-10

2023-01-03

2023-01-03

Completed

146

Inclusion Criteria: * Pregnant at 24 weeks gestation and more * Vaginal bleeding due to placenta previa * Stable hemodynamically * Accept to participate in the trial Exclusion Criteria: * Hypersensitivity to tranexamic acid * Acquired defective color vision * History of venous thromboembolism * Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease) * Smokers * Refused to participate in the trial

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research .\n\nRandom Allocation Software(https://random-allocation-software.software.informer.com/2.0/)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water.\n\nThe 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 146, 'type': 'ACTUAL'}}

2024-01-05