The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery
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|ClinicalTrials.gov Identifier: NCT02678208|
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : March 1, 2016
Postpartum hemorrhage is the most common cause of maternal death across the world, responsible for more than 25% of maternal deaths annually. Although effective tools for prevention and treatment of are available, most are not feasible or practical for use in the developing world where many births still occur at home with untrained birth attendants . primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24 hours of delivery of the fetus which affects the general condition.
Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide , reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of long-term severe morbidity, and approximately 12% of women who survive postpartum hemorrhagewill have severe anemia.
Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Tranexamic Acid Drug: 5% glucose||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Tranexamic acid
received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period
Drug: Tranexamic Acid
Drug: 5% glucose
received 30 mL of 5% glucose over the same period of time.
Drug: 5% glucose
- The changes in Doppler indices of uterine artery after use of tranexamic acid [ Time Frame: 6 months ]
- The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid [ Time Frame: 6 months ]
- The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid [ Time Frame: 6 month ]
- The volume of blood loss after delivery (mL) [ Time Frame: 6 months ]
- Number of patients needed for blood transfusion [ Time Frame: 6 months ]
- The hematocrit values (%) [ Time Frame: 6 months ]
- The hemoglobin concentration [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678208
|Assiut, Egypt, 71111|