Uterine Tamponade for Treatment of Primary Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide
      reaching as high as 60% in some countries.

      Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre
      or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should
      be considered a PPH.

      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to
      include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH
      due to uterine atony. This recommendation is now stronger than the previous guidelines. It
      can be used for women who do not respond to uterotonics or if uterotonics are not available.
      This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a
      higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended
      second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.

      In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and
      Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored
      design that enables conservative management of uterine bleeding in cases of uterine atony and
      other causes of PPH.

      The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a
      wide variety of causes in resource-poor settings.

      One of the new methods that could be used to control PPH is Uterine packing with
      chitosan-covered gauze or Celox.

      Celox Haemostats are dressings with natural material called chitosan to control major
      haemorrhage including life-threatening bleeding . They are simple and effective, stopping
      major bleeding.It was first used by military forces to stop sever bleeding in the scene with
      no other options to stop bleeding. Celox™ granules are actually very high surface area
      flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to
      make a gel like clot, without generating any heat. Celox™ does not set off the normal
      clotting cascade, it only clots the blood it comes directly into contact with. Celox works on
      casualties using anticoagulants and anti-platelet therapy such as aspirin .
    

Detailed description: 
      Balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in
      resource-poor settings.

      One of the new methods that could be used to control PPH is Uterine packing with
      chitosan-covered gauze or Celox.

      Celox Haemostats are dressings with natural material called chitosan to control major
      haemorrhage including life-threatening bleeding . They are simple and effective, stopping
      major bleeding.It was first used by military forces to stop sever bleeding in the scene with
      no other options to stop bleeding. Celox™ granules are actually very high surface area
      flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to
      make a gel like clot, without generating any heat. Celox™ does not set off the normal
      clotting cascade, it only clots the blood it comes directly into contact with. Celox works on
      casualties using anticoagulants and anti-platelet therapy such as aspirin.

      We will be having two groups:

        1. Celox group:

           Celox placement is very simpe . During cesarean section celox is loaded in the lower
           uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs
           after vaginal delivery the celox is inserted through the cervix to pack the lower
           uterine segment. Removal of Celox after 24 hours.

        2. Bakri balloon group:

      Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter.
      Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under
      ultrasound guidance; making sure that the entire portion of the balloon passes the cervical
      canal above the internal cervical os. Once the correct placement is confirmed, inflate the
      balloon with sterile saline using the enclosed syringe.
    

Intervention name(s): Celox group; Bakri Balloon
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment