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Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section

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ClinicalTrials.gov Identifier: NCT02739815
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Al-Azhar University
Information provided by (Responsible Party):
Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital

Brief Summary:
This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS.

Condition or disease Intervention/treatment Phase
Hemorrhage of Cesarean Section and/or Perineal Wound Postpartum Hemorrhage Drug: Normal Saline containing a prophylactic Antibiotic 1 g Drug: Tranexamic Acid Phase 4

Detailed Description:

Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.

The incidence of CS is increasing, and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL). CS rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after CS, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Women who undergo a CS are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent CS, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.

TXA is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analogue; ε-aminocaproic acid. It competitively inhibits the activation of plasminogen to plasmin, by binding to specific sites of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clots. Its intravenous administration has been routinely used for many years to reduce or prevent excessive hemorrhage in various medical conditions or disorders (helping hemostasis), also during and after surgical procedures like benign hysterectomy, open heart surgeries, scoliosis surgery, oral surgery, liver surgeries, total hip or knee arthroplasty, and urology. It has been shown to be very useful and efficient in reducing blood loss and incidence of blood transfusion in these surgeries, and decreases the risk of death in bleeding trauma patients. It was also included in the World Health Organization (WHO) Model List of Essential Medicines.

About its role in CS, some recent studies showed that TXA has advantage and useful effect safely in reducing blood loss and requirement of additional ecbolics. Its doses used intravenously to reduce blood loss at CS were a bolus of 1gm, 10 mg/kg, or 15 mg/kg which had an advantage over 10 mg/kg in anemic parturients. No defined safe prophylactic intravenous TXA dose being found in searching literature having an advantage over other doses in reducing total blood loss especially at secondary uncomplicated LSCS.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study For Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section: A Randomised Controlled Trial
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Will receive a placebo (10 ml of distilled water) in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Name: Solution of Sodium Chloride 0.9 %

Active Comparator: T1
Will receive Tranexamic acid 15 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Name: Solution of Sodium Chloride 0.9 %

Drug: Tranexamic Acid
Tranexamic acid
Other Name: TXA

Active Comparator: T2
Will receive Tranexamic acid 20 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Name: Solution of Sodium Chloride 0.9 %

Drug: Tranexamic Acid
Tranexamic acid
Other Name: TXA

Active Comparator: T3
Will receive Tranexamic acid 25 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Name: Solution of Sodium Chloride 0.9 %

Drug: Tranexamic Acid
Tranexamic acid
Other Name: TXA




Primary Outcome Measures :
  1. Total Blood Loss Volume [ Time Frame: Up to 7 hours ]
    Estimating Total Blood Loss Volume (ml) during and after Caesarean Section, up to 6 hours post-operative.


Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: Up to One hour ]
    Duration of Caesarean Section estimating (min)

  2. Hemoglobin level (Hb) [ Time Frame: 6 hours ]
    6 hours post-operative hemoglobin level (mg/dL) estimating.

  3. Maternal weight (W) [ Time Frame: 2 hours ]
    2 hours post-operative maternal weight (kg) estimating

  4. Hematocrit value (Hct) [ Time Frame: 6 hours ]
    6 hours post-operative hematocrit value (%) estimating.

  5. Need for blood or blood products transfusion [ Time Frame: Up to 6 hours ]
    Need for other medical measures to arrest and manage bleeding (transfusion of blood or blood products)

  6. Need for additional ecbolics [ Time Frame: Up to 6 hours ]
    Need for other medical measures to arrest and manage bleeding if there is a uterine atony (more than five units of intravenous Syntocinon®)

  7. Need for hysterectomy [ Time Frame: Up to 6 hours ]
    Need for other surgical measures to arrest and manage bleeding (Hysterectomy)

  8. Need for uterine artery ligation [ Time Frame: Up to 6 hours ]
    Need for other surgical measures to arrest and manage bleeding (Uterine artery ligation)

  9. Need for B-lynch [ Time Frame: Up to 6 hours ]
    Need for other surgical measures to arrest and manage bleeding if there is a uterine atony (B-lynch)

  10. APGAR Score [ Time Frame: Up to 30 minutes ]
    APGAR Score as index for any neonatal side effects of medications given

  11. Any sign for developing a thromboembolic disorder (Maternal) [ Time Frame: One week ]
    As index for any maternal side effects of medications given

  12. Blood pressure [ Time Frame: Up to 2 hours ]
    Measuring maternal blood pressure (mmHg) immediately postoperative and after 2 hours postoperative.

  13. Pulse rate [ Time Frame: Up to 2 hours ]
    Measuring maternal blood puse rate (/minute) immediately postoperative and after 2 hours postoperative.



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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:

  • Maternal average age of 20-40 years.
  • Singleton pregnancy at term between 38±5 days and 40 weeks.
  • Elective planned or emergency secondary lower segment caesarean sections (LSCS).

Exclusion Criteria:

  • Women with severe medical and surgical complications as any of the following will be excluded :

    • Heart, liver, kidney, or brain diseases, and blood disorders.
    • Abruptio placenta, and placental abnormalities or accrete syndromes.
    • Polyhydramnios, macrosomia, preeclampsia, or allergy to tranexamic acid.
    • History of thromboembolic disorders, or severe anemia.

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): NCT02739815


Locations
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Egypt
Al-Azhar University, Faculty of Medicine for Boys ( Cairo ), Al-Hussein University Hospital
Cairo, Egypt
Sponsors and Collaborators
Talkha Central Hospital
Al-Azhar University
Investigators
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Principal Investigator: Amro M. Hetta, MS Student Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
Study Director: Mahmoud E. Mohammed, Professor Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
Study Chair: Yehia A. Wafa, Chairman Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN

Publications:
Yehia AH, Koleib MH, Abdelazim IA, Atik A. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial. Asian Pacific Journal of Reproduction. 2014 Mar 31;3(1):53-6.
Tarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, Gavrychenko D. Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care. 2012;16(Suppl 1):P439.
Mayur G, Purvi P, Ashoo G, Pankaj D. Efficacy of tranexamic acid in decreasing blood loss during and after cesarean section: a randomized case controlled prospective study. J Obstet Gynecol India. 2007;57(3):227-30.
Gibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.
Gupta A, Dwivedi Y, Shakya V, Srivastva U, Saxena A, Agarwal AM, et al. Efficacy of Tranexamic Acid in Reducing Perioperative Blood Loss During Caesarean Section: A Placebo Controlled Double Blind Study. International Journal of Scientific Research 2016, 5(3).

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Responsible Party: Amro Mohamed Ibrahim Ibrahim Hetta, Master Degree Student of Obstetrics and Gynecology, Al-Azhar University, Talkha Central Hospital
ClinicalTrials.gov Identifier: NCT02739815     History of Changes
Other Study ID Numbers: OG1
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital:
Caesarean Section
Tranexamic Acid
Postpartum Hemorrhage
Ecbolics

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Pharmaceutical Solutions
Anti-Bacterial Agents
Antibiotics, Antitubercular
Tranexamic Acid
Anti-Infective Agents
Antitubercular Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants