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

NCT02678208 | Completed Phase 2

• 1 other identifier: TBBH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

placebo

OTHER

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

Drug: 5% glucose

Interventions

Tranexamic Acid DRUG

Tranexamic acid

5% glucose DRUG

Tranexamic acid; placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women (37-42 weeks),
• with spontaneous labor
• Women who were expected to normal vaginal birth.
• women with a live fetus.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Glucose

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)