Clinical trial NCT02861482: Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage
Official title: Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: PPH, Bakri Ballon
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: The Third Affiliated Hospital of Guangzhou Medical University
name: Guangzhou Women and Children's Medical Center
name: Huadu District People's Hospital of Guangzhou
name: Shenzhen Maternity & Child Healthcare Hospital
name: Dongguan Maternity & Child Health Hospital
name: Zhuhai Maternity & Child Healthcare Hospital
name: The First Maternity & Child Healthcare Hospital of Huizhou
name: Nanhai Women's and Children's Hospital
name: Jiangmen Maternity & Child Health Care Hospital
name: The Third Affiliated Hospital of Southern Medical University
name: Southern Medical University, China
name: Zhongshan Dongsheng hospital
name: Xiaolan People's Hospital of Zhongshan
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Baoan District People's Hospital of Shenzhen
name: Zengcheng District People's Hospital of Guangzhou
First posted: 2016-08-10
Enrollment: 472
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood loss after Bakri Ballon temponade
timeFrame: from using Bakri Ballon Temponade to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs
Secondary outcomes:
measure: Ratio of Bakri Ballon only without other invasive measures in succeeding controlling PPH to the number of cases
timeFrame: From delivery to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
name: Zilian Wang, M.D.,PhD
role: STUDY_DIRECTOR
References: