Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum
Condition: Cesarean Section Complications
MeSH terms: Placenta Accreta
Study type: Interventional

Summary: 
      PAS is an obstetrics condition that is closely linked with massive obstetrical hemorrhage
      with a varied incidence about once in every 533 live births. It is considered one of the
      causes of massive transfusion (>4 units of packed red blood cells) and cesarean hysterectomy.

      It is estimated that peripartum hysterectomies are performed in approximately0.08% of all
      deliveries. A large study from the United Kingdom noted that 38% were a result of PAS. More
      recently, population-based analyses show that PAS is the indication for the majority of
      peripartum hysterectomies.

      Bleeding at the time of peripartum hysterectomy for PAS is often substantial. Nearly 90% of
      patients need blood products, while 38% of patients need a massive blood transfusion.

      There is a 30% risk of an ICU admission, thromboembolic disease, readmission, reoperation,
      poor wound healing, and a reported rate of surgical re-exploration ranging from 4% to 33%.
      The risk of maternal death reported being as high as 7% (although less in most recent series)
      Therefore, adequate homeostatic techniques are essential. Currently, surgical hemostasis can
      be secured by a variety of methods, including mechanical sutures (or clamping), electric
      coagulation, ultrasonically activated scalpel or drugs.

      TA is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the
      binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of
      blood loss depending on the implication of the coagulation and fibrinolysis processes .
      However, concerns about possible thromboembolic events with the parental administration of TA
      has stimulated increasing interest in its topical Use
    

Detailed description: 
      Eligible participants were allocated to one of three groups. Group (I): patients received 110
      ml normal saline IV just before skin incision Group (II): patients received 1 gm TA (2
      ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision.
      Group (III): patients received 2 gm topical TA (4 ampoules of Capron 500 mg/5 ml) applied on
      the placental bed after placental delivery. Patients were randomized to three groups, each
      compromised of 43 patients according to a three-blocked randomization list which was coded (1
      or 2 or 3) at 1:1:1 ratio. The three parallel groups were prepared using a Computer-generated
      randomization system. The allocated groups will be concealed in serially numbered sealed
      opaque envelopes that will only be opened after recruitment. The patient allocation will be
      performed prior to the induction of anesthesia by an independent person, who will not
      otherwise be involved in this study. The trial will be appropriately blinded; the
      participants, outcome assessors and the surgeon performing the procedure will be blinded to
      the medication type, which will be used. In all eligible participants, CH was performed under
      general anesthesia by the same operative and anesthesia team. A dose of 1 g of
      first-generation cephalosporin (Cefazolin®; Bristol Mayers Squibb, Cairo, Egypt) was
      administered intravenously immediately prior to skin incision. The abdomen was exposed
      through Pfannensteil incision. After skin incision, the subcutaneous fat and abdominal fascia
      were opened crosswise, and the rectus muscle was opened on the midline, the parietal
      peritoneum was opened longitudinally, the visceral peritoneum was opened transversely and
      dissected downwards with the bladder and kept against symphysis pubis by a Doyen retractor,
      followed by transverse incision of the uterus at the upper border of the placenta to avoid
      transplacental incision which provoke severe bleeding.

      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. they
      received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal
      saline) by slow intravenous injection at an approximate rate of 1 mL per min. Throughout the
      operation irrigation was done by 60 ml of (2g tranexamic acid (10 ml) diluted in 100 ml of
      sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.).At the end of operation
      another dose of 60 ml of (1g tranexamic acid (10 ml) diluted in 50 ml of sodium chloride
      0.9%) or placebo ( 60 ml of sodium chloride 0.9%.) was left intraabdominal then 1
      intraperitoneal suction drain was routinely used in all patients the drains were closed for 3
      hour postoperative , after that time the drains were opened and removed on the second
      postoperative day unless otherwise indicated.. To ensure a sufficiently high concentration of
      topical tranexamic acid, it was diluted only to a volume sufficient to moisten a large wound
      surface. 20 ml moistens at least 1500 cm2.
    

Intervention name(s): intravenous tranexamic acid; Topical tranexamic acid; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy; 2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus In topical tranexamic acid group gauze soaked with 2g tranexamic acid (20 ml) diluted in 200 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) applied on the pelvic bed after Cesarean hysterectomy. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.; 110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
Other intervention name(s): Active Comparator; Active Comparator; Placebo Comparator
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants were allocated to one of three groups. Group (I): patients received 110 ml normal saline IV just before skin incision Group (II): patients received 1 gm TA (2 ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision. Group (III): patients received 2 gm topical TA (4 ampoules of Capron 500 mg/5 ml) applied on the placental bed after placental delivery.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cesarean section; placenta accreta spectrum; tranexamic acid