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

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ClinicalTrials.gov Identifier: NCT02678208
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Tranexamic Acid Drug: 5% glucose Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tranexamic acid
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
received 30 mL of 5% glucose over the same period of time.
 Drug: 5% glucose


Outcome Measures
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Primary Outcome Measures :
  1. The changes in Doppler indices of uterine artery after use of tranexamic acid [ Time Frame: 6 months ]
  2. The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid [ Time Frame: 6 months ]
  3. The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. The volume of blood loss after delivery (mL) [ Time Frame: 6 months ]
  2. Number of patients needed for blood transfusion [ Time Frame: 6 months ]
  3. The hematocrit values (%) [ Time Frame: 6 months ]
  4. The hemoglobin concentration [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678208


Locations
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Egypt
Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02678208     History of Changes
Other Study ID Numbers: TBBH
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
 Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants