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

Phase 2

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Tranexamic Acid; Drug: 5% glucose

• Registration Number: NCT02678208
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2016-02
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Last Update Submitted: 2016-02-27
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	5% glucose	received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period
placebo	5% glucose	received 30 mL of 5% glucose over the same period of time.
Tranexamic acid	Tranexamic Acid	received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period

Primary Outcome Measures

Name	Time	Method
The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid	6 month
The changes in Doppler indices of uterine artery after use of tranexamic acid	6 months
The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid	6 months

Secondary Outcome Measures

Name	Time	Method
The volume of blood loss after delivery (mL)	6 months
The hemoglobin concentration	6 months
Number of patients needed for blood transfusion	6 months
The hematocrit values (%)	6 months

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt