Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major
      causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic
      medical disorders (including inherited and acquired coagulopathy). Management of PPH contains
      the application of uterotonic agents, using hemostasis agents, transfusion of blood component
      products, conservative procedures (intrauterine packing or balloon tamponade, compression
      sutures, vascular ligation and uterine artery embolization using sponges), and even
      hysterectomy.

      The Bakri Balloon has attained its efficacy and popularity ever since it was invented by
      Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH
      management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data
      of preventive usage.

      The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early
      management of PPH.
    

Detailed description: 
      Data of 472 patients from 20 different hospitals had a Bakri balloon tamponade. Enrolled
      patients would follow the next process: assessment of blood loss intrapartum and 2 hours
      postpartum; laying the Bakri Balloon; assessment of blood loss, uterine contraction and
      complications after Bakri Balloon tamponade; further conservative surgical measures (uterine
      placation (B-lynch suture), arterial embolization; artery ligation; cervical cerclage) or
      even hysterectomy if necessary; recording the puerperium infection and involution of uterus.

      Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard
      deviations or median with interquartile range. Differences between groups were assessed by
      Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate.
      Correlation analysis was performed using the Spearman rank correlation method. To identify
      independent relationships and adjust the effects of covariates, multiple linear regression
      analyses were performed. P values of <0.05 were considered significant.
    

Intervention name(s): Bakri Balloon; Oxytocin; Hemabate; Duratocin; Uterine Massage; B-lynch Suture; Uterine Artery Embolization using sponges; Cervical cerclage; Hysterectomy; Blood Product
Intervention type(s): Device; Drug; Drug; Drug; Procedure; Procedure; Procedure; Procedure; Procedure; Drug
Intervention description(s): Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped; using oxytocin(usage:20IU oxytocin in 500ml lactated Ringer's, ivgtt to a maximum of 60IU) for the first step when dealing with PPH before laying Bakri Balloon; using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon; using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon; continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon; One of conservative surgical procedures if Bakri Balloon didn't work; One of conservative surgical procedures if Bakri Balloon didn't work; One of conservative surgical procedures if Bakri Balloon didn't work; Hysterectomy with all the above measures not working; transfusion of blood product if necessary no matter which surgical procedure has been taken
Intervention MeSH terms: Oxytocin; Carboprost tromethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PPH, Bakri Ballon