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

Study Overview
=================
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.

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: 5% glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid<br>received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period | Drug: Tranexamic Acid<br> <br> Drug: 5% glucose<br> <br> |
| Other: placebo<br>received 30 mL of 5% glucose over the same period of time. | Drug: 5% glucose<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of blood loss after delivery (mL) |  | 6 months | 
| Number of patients needed for blood transfusion |  | 6 months | 
| The hematocrit values (%) |  | 6 months | 
| The hemoglobin concentration |  | 6 months |