Postpartum Hemorrhage
Conditions
Keywords
PPH, Bakri Ballon
Brief 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.
Interventions
DEVICEBakri Balloon
Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped
DRUGOxytocin
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
DRUGHemabate
using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon
DRUGDuratocin
using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon
PROCEDUREUterine Massage
continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon
PROCEDUREB-lynch Suture
One of conservative surgical procedures if Bakri Balloon didn't work
PROCEDUREUterine Artery Embolization using sponges
One of conservative surgical procedures if Bakri Balloon didn't work
PROCEDURECervical cerclage
One of conservative surgical procedures if Bakri Balloon didn't work
PROCEDUREHysterectomy
Hysterectomy with all the above measures not working
DRUGBlood Product
transfusion of blood product if necessary no matter which surgical procedure has been taken
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou Women and Children's Medical Center
Huadu District People's Hospital of Guangzhou
Shenzhen Maternity & Child Healthcare Hospital
Dongguan Maternity & Child Health Hospital
Zhuhai Maternity & Child Healthcare Hospital
The First Maternity & Child Healthcare Hospital of Huizhou
Nanhai Women's and Children's Hospital
Jiangmen Maternity & Child Health Care Hospital
The Third Affiliated Hospital of Southern Medical University
Southern Medical University, China
Zhongshan Dongsheng hospital
Xiaolan People's Hospital of Zhongshan
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Baoan District People's Hospital of Shenzhen
Zengcheng District People's Hospital of Guangzhou
Dongyu Wang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 47 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Outcome results
None listed