Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section
Condition: Hemorrhage of Cesarean Section and/or Perineal Wound; Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Normal Saline containing a prophylactic Antibiotic 1 g; Tranexamic Acid
Intervention type(s): Drug; Drug
Intervention description(s): 500 ml of normal saline containing a prophylactic Antibiotic 1 g.; Tranexamic acid
Other intervention name(s): Solution of Sodium Chloride 0.9 %; TXA
Intervention MeSH terms: Anti-Bacterial Agents; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Caesarean Section; Tranexamic Acid; Postpartum Hemorrhage; Ecbolics