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Clinical trial

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

ID
Name
HMU5
Description
Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality
Trial arms
Trial start
2023-01-10
Estimated PCD
2024-02-02
Trial end
2024-02-10
Status
Completed
Treatment
Tranexamic acid injection
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.
Arms:
Tranexamic acid group
Other names:
Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India
Glucose water 5%
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.
Arms:
Glucose water group
Other names:
Glucose B.Braun
Size
116
Primary endpoint
Vaginal blood loss
Up to time of delivery
Gestational age
Up to time of delivery
Favorable perinatal outcome
7 days post partum
Eligibility criteria
Inclusion Criteria: * 24 weeks gestation and more * Stable hemodynamically * Accepted to participate Exclusion Criteria: * Hypersensitivity to tranexamic acid * Defective color vision * History of venous thromboembolism * Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease) * Smoker * Refused to participate in the trial
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization for both groups will be done using the Randomization Allocation Software program. Blindness in each group will be confirmed by a pharmacist who is not involved in the study and will have the codes belonging to the type of 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': 'DOUBLE', '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', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}
Updated at
2024-02-13

1 organization

1 product

2 indications

Organization
Hawler Medical University
Product
Tranexamic acid
Indication
Abnormal Vaginal Bleeding
Indication
Postterm Pregnancy