Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- Blood loss after Bakri Ballon temponade
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Bakri Balloon (Device)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Oxytocin (Drug)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Hemabate (Drug)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Duratocin (Drug)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Uterine Massage (Procedure)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: B-lynch Suture (Procedure)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Uterine Artery Embolization using sponges (Procedure)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Cervical cerclage (Procedure)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Hysterectomy (Procedure)
Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
干预措施: Blood Product (Drug)
结局指标
主要结局
Blood loss after Bakri Ballon temponade
时间窗: from using Bakri Ballon Temponade to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs
次要结局
- 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)
研究者
Dongyu Wang
M.D.
First Affiliated Hospital, Sun Yat-Sen University