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OpenTrials
Completed

NCT Number: NCT02678208

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

5% glucose

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 9, 2016
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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