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Tranexamic Acid for the Prevention of Postpartum Haemorrhage

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ClinicalTrials.gov Identifier: NCT04707950
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Abou Bakr Mohamed El Nashaar, Benha University

Study Description
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Brief Summary:
Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Tranexamic Acid 100 milligram/Milliliter Drug: Oxytocin Phase 1 Phase 2

Detailed Description:

Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).

The second dose of TXA 1 g Intravenous can be given if:

  • Bleeding continues after 30 minutes
  • Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess efficacy of TXA in prevention of PPH and reduction of intra and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).

The second dose of TXA 1 g Intravenous can be given if:

  • Bleeding continues after 30 minutes
  • Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Tranexamic Acid for the Prevention of Postpartum Haemorrhage After Cesarean Section in High-risk Patients ( a Randomized Control Trial ).
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: study group will be given tranexamic acid

Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).

The second dose of TXA 1 g Intravenous can be given if:

  • Bleeding continues after 30 minutes
  • Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
 Drug: Tranexamic Acid 100 milligram/Milliliter

Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).

The second dose of TXA 1 g Intravenous can be given if:

  • Bleeding continues after 30 minutes
  • Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Other Name: Study group

Drug: Oxytocin
both groups will be given oxytocin as a standard management
Other Name: Control group
Placebo Comparator: Control group
The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )
 Drug: Oxytocin
both groups will be given oxytocin as a standard management
Other Name: Control group


Outcome Measures
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Primary Outcome Measures :
  1. Volume of blood loss [ Time Frame: 30 minutes after baby delivery ]
    150 ml/pack


Secondary Outcome Measures :
  1. transfusion requirements [ Time Frame: 7 days postpartum ]
    number of women transfused blood

  2. additional medical intervention [ Time Frame: 48 hours postpartum ]
    number of patients were treated by an additional medical intervention

  3. additional surgical or radiological interventions to control bleeding [ Time Frame: 7 days postpartum ]
    number of patients were treated by additional surgical or radiological intervention

  4. Change in maternal hematocrit concentration [ Time Frame: 48 hours postpartum ]
    Hematocrit concentration (Percent)

  5. Tranexamic acid side effects [ Time Frame: 24 hours postpartum ]
    number of patients suffered from side effects

  6. thromboembolic events [ Time Frame: 7 days postpartum ]
    number of patients suffered from thromboembolic events

  7. Maternal death [ Time Frame: 7 days postpartum ]
    Number of women will die.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women with high risk for postpsrtum hemorrhage after ceserean section
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Scheduled or unscheduled cesarean delivery. Singleton or twin gestation.

Women at high risk for PPH after cesarean section:

Placenta previa, accreta, increta or percreta. haematocrit (HCT) < 30%. Bleeding at admission. History of Postpartum haemorrhage. Abnormal vital signs (hypotension or tachycardia). Previous Cesarean or uterine surgery. More than four previous deliveries. Multiple Gestation. Large Uterine fibroids. Chorioamnionitis. Magnesium sulphate use. Prolonged use of oxytocin.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Women who are not at high risk for PPH.
  3. Women attending for normal vaginal delivery.
  4. Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.
  5. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.
  6. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.
  7. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
  8. Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.
  9. Hypersensitivity to TXA or any of its ingredients.
  10. Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative haemorrhage
  11. Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..
  12. Active cancer, because of the risk of thromboembolism.
  13. Congestive heart failure requiring treatment, because of the risk of thrombosis.
  14. If there is no haemoglobin and hematocrit result available from the last 4 weeks since it is necessary to measure the postoperative change in haemoglobin and hematocrit.
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): NCT04707950


Contacts
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Contact: Ahmed A Morad, MD 0201224214435 awalid217@yahoo.com
Contact: Abubaker M Elnashar, MD

Locations
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Egypt
Benha university hospital Recruiting
Banhā, Banha, Egypt, 13511
Contact: Ahmed A Morad, MD    0201224214435    awalid217@yahoo.com   
Principal Investigator: Aboubakr M Elnashar, MD         
Sub-Investigator: Ahmed A Walid Anwar, MD         
Sub-Investigator: Ehab E Barakat, MD         
Benha University Active, not recruiting
Banhā, Banha, Egypt, 13511
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Abubaker M Elnashar, MD Benha Faculty of Medecine
More Information
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Responsible Party: Dr. Abou Bakr Mohamed El Nashaar, Professor, Benha University
ClinicalTrials.gov Identifier: NCT04707950    
Other Study ID Numbers: SEAbdelfattah
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Abou Bakr Mohamed El Nashaar, Benha University:
Tranexamic acid
postpartum hemorrhage
cesarean section
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Tranexamic Acid
Oxytocin
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants