Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Device: Bakri Balloon
* Drug: Oxytocin
* Drug: Hemabate
* Drug: Duratocin
* Procedure: Uterine Massage
* Procedure: B-lynch Suture
* Procedure: Uterine Artery Embolization using sponges
* Procedure: Cervical cerclage
* Procedure: Hysterectomy
* Drug: Blood Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with vaginal or cesarean delivery; PPH caused by: Uterine Atony, Placenta Factors, Coagulation disorders, Hematological disorders, Hepatic diseases, Obstetric DIC; Not reacting well to continuous uterine massage or uterotonic agents including oxytocin (0.04IU/L ivgtt to a maximum of 60IU), Hemabate (250-500ug im) and Duratocin (100ug iv); Without other conservative surgical treatment(uterine compression suture, internal arterial embolism; vascular ligation); Signing the informed consents; Exclusion Criteria: Has undergone or will undergo conservative surgical treatment(uterine compression suture, international arterial embolism; artery ligation); Impaired soft birth canal injury; Untreated uterine deformity; Definite indication for uterectomy.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bakri Ballon<br>All the enrolled patients who would undergo the laying of Bakri Balloon | Device: Bakri Balloon<br>* Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped<br>Drug: Oxytocin<br>* 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<br>Drug: Hemabate<br>* using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon<br>Drug: Duratocin<br>* using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon<br>Procedure: Uterine Massage<br>* continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon<br>Procedure: B-lynch Suture<br>* One of conservative surgical procedures if Bakri Balloon didn't work<br>Procedure: Uterine Artery Embolization using sponges<br>* One of conservative surgical procedures if Bakri Balloon didn't work<br>Procedure: Cervical cerclage<br>* One of conservative surgical procedures if Bakri Balloon didn't work<br>Procedure: Hysterectomy<br>* Hysterectomy with all the above measures not working<br>Drug: Blood Product<br>* transfusion of blood product if necessary no matter which surgical procedure has been taken<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss after Bakri Ballon temponade |  | from using Bakri Ballon Temponade to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Bakri Ballon only without other invasive measures in succeeding controlling PPH to the number of cases |  | From delivery to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPH, Bakri Ballon