Balloon Tamponade for Atonic 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.PPH can also be a cause of long-term severe
      morbidity, and approximately 12% of women who survive PPH will have severe anemia.

      Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth
      and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has
      the potential to produce hemodynamic instability should be considered a PPH. However,
      clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within
      the first 24 hours after delivery and approximately 70% of these cases are due to uterine
      atony. Furthermore, uterine tony is defined as the failure of the uterus to contract
      adequately after the child is born.

      Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach
      including the exclusion of retained products of conception and genital tract trauma. Uterine
      atony, which is the most common cause, the management of uterine atony is an established
      stepwise protocol that in many international guidelines.

      Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as
      excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the
      recommended uterotonic drug for the treatment of PPH.

      If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin,
      intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including
      sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade
      is recommended for the treatment of primary PPH due to uterine atony in women who do not
      respond to uterotonics or if uterotonics are not available.

      Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus
      and inflating it with water could achieve tamponade, case series and other studies have
      suggested that various uterine balloon tamponade(UBT) devices may be effective in treating
      PPH. The studies used various types of UBT devices, including a condom catheter, a Foley
      catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine
      Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success
      rate of UBT does not significantly vary from surgical treatment outcomes.The World Health
      Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the
      American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians
      and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize
      balloon tamponade as a method that could significantly improve the management intractable
      PPH, especially in low-resource areas.

      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 UBT as a recommended second-line
      intervention for the treatment of PPH in their updated guidelines issued in 2012.

      Bakri first published the concept of intrauterine balloon technology in the management of
      hemorrhage secondary to placenta praevia-accreta during caesarean section with or without
      bilateral hypo gastric arterial ligation.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 idea of using a condom as a balloon tamponade was first generated and evaluated in
      Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially
      available UBT devices.
    


Intervention name(s): Bakri balloon; Condom loaded foley's catheter
Intervention type(s): Device; Device
Intervention description(s): is a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies; Under aseptic precautions a sterile rubber catheter was inserted within the condom and tied near the mouth of the condom by a silk thread.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: condom-loaded Foley's catheter; Bakri balloon; primary atonic postpartum hemorrhage