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

NCT ID: NCT02678208

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid

received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

5% glucose

Intervention Type: DRUG

placebo

received 30 mL of 5% glucose over the same period of time.

Group Type: OTHER

5% glucose

Intervention Type: DRUG

Interventions

Tranexamic Acid

Intervention Type: DRUG

5% glucose

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

TBBH

Identifier Type: -

Identifier Source: org_study_id