Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section
Condition: Cesarean Section Complications
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to determine, out of two doses (a standard and a low dose) compared
      to placebo, the optimal and minimal dose of an intravenously administered single bolus of
      tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS).
      Tranexamic acid is an antifibrinolytic agent, which causes a reversible and competitive
      blockade of the lysine binding sites on plasminogen molecules. It is a synthetic analog of
      the amino acid lysine and its action is to reduce blood loss. TA is widely in use in the
      field of obstetrics. Both antepartum and postpartum hemorrhage(PPH) is being treated by TA
      extensively. One study demonstrated for the first time that TA administered to women with
      overt PPH decreases blood loss and maternal morbidity. Prevention of PPH is another
      indication where TA has been used. Varied doses of TA ranging from 1 mg/kg to more than 100
      mg/kg have been used in various surgeries. Even in studies involving CS, the doses used were
      either a bolus of 1 gm or 10 mg/kg intravenously.

      The dose of 1 g or 10 mg/kg is commonly used prophylactically before CS, Because of the lack
      of data on lower doses and TA pharmacokinetics, a low 0.5-g dose should be tested.
    

Detailed description: 
      CS was carried out under subarachnoid block using 2-2.5 ml of 0.5% hyperbaric bupivacaine
      after an informed written consent. Blockade up to T4-T6 level was considered an adequate
      level of anesthesia. After delivery of the neonate, 20 unit of oxytocin in 500 ml normal
      saline will begive at the rate of 8 mU/min intravenously.

      All consenting patients were recruited as a consecutive series to one of the three study
      groups of 120 patients each, based on block random allocation protocol. Neither the patient
      nor the investigator was aware of the group assignment. An anesthesiologist not related to
      the study prepared the drug for every patient.

      Groups were labeled as follows:

      Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose

      Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose

      Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose.

      The drug in all the groups was given intravenously over 20 min before skin incision.

      Monitoring of the pulse rate, blood pressure, Pulse Oximetry (SpO2) and Electrocardiograph
      (ECG) was carried out every 2 min up to 10 min of starting the study drug; then every 5 min
      until the delivery of the baby and thereafter every 15 min until the end of the surgery.
      Blood loss was measured intra-operatively and postoperatively up to 24 h. All material such
      as sponges, mops, pads, and drapes were weighed with an electronic weighing scale before and
      at the end of surgery. A volume of blood in the suction bottle was considered only after the
      placental delivery, to exclude any amniotic fluid volume. The quantity of intra-operative
      blood loss (ml) = (weight of the abdominal swabs and drapes after CS - weight of materials
      prior to CS) + (the volume in the suction bottle after placental delivery in ml).
      Post-operative blood loss was measured by weighing and numbering the vaginal pads used by the
      patient after completion of CS 2 hourly up to 6 h and then 6 hourly up to 24 h.

      Uterine contractility, placental separation, neonatal condition and any side effect caused by
      TA will be noted. Intramuscular methylergometrine would be used as a rescue uterotonic
      treatment when required. Post-operative hemoglobin, hematocrit, serum creatinine, and
      prothrombin time, values were recorded at 24 h. All the parturients were encouraged to start
      early leg exercises and ambulation in the post-operative period.
    

Intervention name(s): normal saline; 1gm tranexamic acid; 0.5 gm tranexamic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 110 ml normal saline IV just before skin incision; 1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision; 0.5 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
Other intervention name(s): placebo comparator; active comparator; active comparator
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. Groups were labeled as follows:
Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose
Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose
Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cesarean section; tranexamic acid; postpartum hemorrhage