The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women
Condition: Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Study type: Interventional

Summary: 
      A full medical history will be obtained from all participants. Obstetric ultrasonography and
      laboratory tests will be performed.According to group assignment, either 1 g(10 mL)
      tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or
      30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision
      over a 5-minute period.

      Following delivery, patients in both groups will receive an intravenous bolus of 5 IU
      oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated
      Ringer's solution(infused at a rate of 125 mL/h)
    

Detailed description: 
      A full medical history will be obtained from all participants. Obstetric ultrasonography and
      laboratory tests will be performed, including prothrombin time, prothrombin concentration,
      complete blood count, and liver and kidney function tests. Maternal body weight and vital
      signs (heart rate, blood pressure, and respiratory rate) will be checked 30 minutes before
      surgery. According to group assignment, either 1 g(10 mL) tranexamic acid (Kapron, Amoun,
      Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of
      5% glucose will be slowly administered intravenously 15 minutes before skin incision over a
      5-minute period.

      Following delivery, patients in both groups will receive an intravenous bolus of 5 IU
      oxytocin (Syntocinon, Novartis, Basel, Switzerland), 1 mL(0.2 mg) intramuscular ergometrine
      (Methergin, Novartis, Basel, Switzerland), and 20 IU oxytocin in 500 mL lactated Ringer's
      solution(infused at a rate of 125 mL/h).

      Fluid monitoring will be performed through rate of infusion and urine output. A complete
      blood count test will be performed 24 hours after delivery. On discharge, patients who
      received tranexamic acid will be given a brief orientation regarding symptoms and signs of a
      thromboembolic event and will be instructed to contact the investigators immediately if any
      occurred.

      All patients will be examined for thromboembolic events at the 1- and 4-week follow-up visits

      EBL will be calculated according to the formula:

      EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where
      EBV is estimated blood volume (mL; weight in kg × 85). For a two-tailed test at an α level of
      0.05, the difference between the two groups regarding the primary outcome measure (EBL) had a
      power of 1.0 (100%) in a post hoc calculation.
    

Intervention name(s): Tranexamic Acid; Cesarean section
Intervention type(s): Drug; Procedure
Intervention description(s): 1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.; Lower segement transverse cesarean section
Other intervention name(s): Kapron; Lower segment elective cesarean section
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention