The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery

Postpartum Hemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678208
• Other study ID #: TBBH
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2016
• Last updated: February 27, 2016
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnant women (37-42 weeks),

• with spontaneous labor

• Women who were expected to normal vaginal birth.

• women with a live fetus.

Exclusion Criteria:

• multiple gestations

• polyhydramnios

• macrocosmic baby

• grand multipara

• women with hypertensive disorders

• previous history of postpartum hemorrhage

• abnormal placentation (placenta previa or placental abruption)

• history of any uterine scarring (including cesarean section)

• history of blood/liver/renal/heart diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic Acid

• 5% glucose

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in Doppler indices of uterine artery after use of tranexamic acid		6 months	Yes
Primary	The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid		6 months	Yes
Primary	The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid		6 month	Yes
Secondary	The volume of blood loss after delivery (mL)		6 months	Yes
Secondary	Number of patients needed for blood transfusion		6 months	Yes
Secondary	The hematocrit values (%)		6 months	Yes
Secondary	The hemoglobin concentration		6 months	Yes