Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongyu Wang
• Collaborators: Baoan District People's Hospital of Shenzhen; Dongguan Maternity & Child Health Hospital; First Affiliated Hospital, Sun Yat-Sen University; Guangzhou Women and Children's Medical Center; Huadu District People's Hospital of Guangzhou; Jiangmen Maternity & Child Health Care Hospital; Nanhai Maternity & Child Healthcare Hospital; Nanhai Women's and Children's Hospital; Shenzhen Maternity & Child Healthcare Hospital; Sixth Affiliated Hospital, Sun Yat-sen University; Southern Medical University, China; The Eastern Hospital of The First Affiliated Hospital, Sun Yat-sen University; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; The First Maternity & Child Healthcare Hospital of Huizhou; The Six Affiliated Hospital of Sun Yat-sen University; The Third Affiliated Hospital of Guangzhou Medical University; The Third Affiliated Hospital of Southern Medical University; Third Affiliated Hospital, Sun Yat-Sen University; Xiaolan People's Hospital of Zhongshan; Zengcheng District People's Hospital of Guangzhou; Zhongshan Dongsheng hospital; Zhuhai Maternity & Child Healthcare Hospital
• Treatments: Carboprost; Carboprost tromethamine; Oxytocin

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.