Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Intervention: Tranexamic Acid; Oxytocin
Intervention description: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.; 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Intervention MeSH terms: Tranexamic Acid; Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.
Masking: None (Open Label)
Masking description: Trial is an open label randomized control trial
Enrollment: 506.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide
      accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of
      death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery,
      bleeding trauma patients, and menorrhagia.

      The investigators seek to determine the efficacy of TXA in reducing PPH during and after
      elective caesarean section.

      Methods and Design The investigators intend to perform an open label randomized control study
      of 1,162 women who are undergoing elective caesarean section. The participants will be
      randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision
      or not to receive the intervention. Prophylactic oxytocin will be administered to all the
      women.

      The primary outcome will be incidence of PPH defined by blood loss equal to or more than
      1,000ml calculated by determining the difference in haematocrit values taken prior to and 48
      hours after caesarean section.

      Discussion In addition to prophylactic uterotonic administration, TXA is a complementary
      component acting on the haemostatic process that can be used in the third stage of labour to
      prevent PPH. It is a promising intervention that is cheap, easy to administer and would be
      easy to add to routine delivery protocols in hospitals. It would also help to conserve
      precious resources by reducing the need for blood products, and expensive surgical
      interventions to manage PPH.

      This large adequately powered randomized study seeks to determine the efficacy of TXA to
      validate its routine use at caesarean section to prevent PPH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant woman with signed informed consent***

          -  Understand English and/or Shona

          -  Estimated gestational age of 38 weeks or older

          -  Requiring Elective Caesarean Section defined as caesarean section performed before
             onset of labour

          -  Live intrauterine fetus

               -  The study will enrol participants who are Pregnant and who have a signed informed
                  Consent form. Some of the pregnant women may be minors as they are occasionally
                  included in patients planned for elective caesarean section for varying
                  indications. Their inclusion also will make the results of the trial
                  generalizable to elective caesarean section patients attended to at the two study
                  hospitals. Consent will be sought from a legally authorized representative such
                  as the parent or guardian.

        Exclusion Criteria:

          -  Placental Abruption

          -  Emergency caesarean section

          -  Current or previous history of significant disease including heart disease, liver,
             renal disorders

          -  Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or
             arterial thrombosis (angina pectoris, myocardial infarction, stroke)

          -  History of epilepsy or seizures

          -  Autoimmune disease

          -  Sickle cell disease

          -  Severe haemorrhagic disease

          -  Intrauterine fetal demise

          -  Eclampsia/HELLP syndrome

          -  Administration of anticoagulants - clexane or antiplatelet agents in the week prior to
             delivery