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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

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date March 1, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2016)
  • The changes in Doppler indices of uterine artery after use of tranexamic acid [ Time Frame: 6 months ]
  • The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid [ Time Frame: 6 months ]
  • The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • The changes in Doppler indices of subendometrial blood vessels after use of tranexamic acid [ Time Frame: 6 month ]
  • The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02678208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2016)
  • The volume of blood loss after delivery (mL) [ Time Frame: 6 months ]
  • Number of patients needed for blood transfusion [ Time Frame: 6 months ]
  • The hematocrit values (%) [ Time Frame: 6 months ]
  • The hemoglobin concentration [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • The volume of blood loss after delivery (mL) [ Time Frame: 6 months ]
  • Number of patients needed for blood transfusion, [ Time Frame: 6 months ]
  • The hematocrit values (%) [ Time Frame: 6 months ]
  • The hemoglobin concentration [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE
  • Drug: Tranexamic Acid
  • Drug: 5% glucose
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Tranexamic Acid
    • Drug: 5% glucose
  • placebo
    received 30 mL of 5% glucose over the same period of time.
    Intervention: Drug: 5% glucose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678208
Other Study ID Numbers  ICMJE TBBH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Mohammed Khairy Ali, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP