Blood Loss During Cesarean Delivery in Placenta Previa Patients
Condition: Placenta Previa
MeSH terms: Placenta Previa
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy and safety profile of intravenous tranexamic acid versus intrauterine
      misoprostol in reducing the blood loss during and after cesarean delivery in pregnant women
      diagnosed with placenta previa
    

Detailed description: 
      Placenta previa is defined as complete or partial covering of the internal os of the cervix
      with the placenta, at more than 16 weeks of gestation. It affects 0.3% to 2% of pregnancies
      in the third trimester and has become more evident secondary to the increasing rates of
      cesarean delivery (CD).

      Placenta previa is a major risk factor for postpartum hemorrhage (PPH) and can lead to
      maternal and neonatal morbidity and mortality. Uncontrolled PPH from placenta previa may
      necessitate blood transfusion, hysterectomy, admission to the intensive care unit, or even
      death.

      The efficacy of routine administration of oxytocin, to reduce the frequency of PPH after
      vaginal and cesarean birth is well-established. The Royal College of Obstetricians and
      Gynecologists recommends a slow IV bolus dose of 5 IU of oxytocin after delivery of the
      neonate in CD to ensure adequate uterine contractility, reduce intraoperative blood loss and
      prevent PPH. Likewise, the American College of Obstetricians and Gynecologists recommends the
      practice to use oxytocin but infusion instead of a bolus dose. Regardless of the mode of
      administration, oxytocin use in the setting of CD may result in maternal adverse effects,
      such as hypotension and tachycardia.

      Misoprostol, a prostaglandin E1 analogue with strong uterotonic properties binds to
      myometrial cells to cause strong myometrial contractions. Misoprostol has been suggested as
      an alternative to injectable uterotonic agents for preventing PPH following vaginal or CD. It
      can be used orally, sublingually, buccally, rectally or put intrauterine with similar
      efficacy as oxytocin in reducing blood loss, preventing and treating PPH. Because of its
      availability, low cost, thermal stability, and ease of administration, misoprostol is
      suitable for worldwide use even in low resource settings in developing countries.

      Tranexamic Acid (TA) is an analogue of lysine that inhibits fibrinolysis by competitively
      binding to plasminogen. It prevents the lysis of formed clot by inhibiting activation of
      plasminogen and plasmin. It is ten times more potent than amino-caproic acid. Several studies
      had assessed the use of TA in both the prophylaxis against and the treatment of PPH with the
      conclusion that TA reduces the following; blood loss in women with PPH, the need for
      hysterectomy, the risk of severe anemia and the need for further blood transfusion; hence,
      this could contribute significantly to the goal of reducing maternal mortality
    

Intervention name(s): Tranexamic acid; Misoprostol; Oxytocin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 1 gm tranexamic acid diluted in 20 ml of Glucose 5% 15 minutes prior to skin incision and a slow IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following delivery of the baby.; Patients will receive 400 microgram misoprostol which will be inserted inside the uterus near the cornu after delivery of the placenta and a slow IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h).
.; Patients will receive an IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby.
Other intervention name(s): Kapron; Cytotec; Syntocinon
Intervention MeSH terms: Misoprostol; Tranexamic Acid; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention