Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

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.

Conditions

• Postpartum Hemorrhage

Interventions

DEVICE

Bakri Balloon

Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped

DRUG

Oxytocin

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

DRUG

Hemabate

using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon

DRUG

Duratocin

using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon

PROCEDURE

Uterine Massage

continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon

PROCEDURE

B-lynch Suture

One of conservative surgical procedures if Bakri Balloon didn't work

PROCEDURE

Uterine Artery Embolization using sponges

One of conservative surgical procedures if Bakri Balloon didn't work

PROCEDURE

Cervical cerclage

One of conservative surgical procedures if Bakri Balloon didn't work

PROCEDURE

Hysterectomy

Hysterectomy with all the above measures not working

DRUG

Blood Product

transfusion of blood product if necessary no matter which surgical procedure has been taken

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• The Third Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Huadu District People's Hospital of Guangzhou

  collaborator OTHER

• Shenzhen Maternity & Child Healthcare Hospital

  collaborator OTHER

• Dongguan Maternity & Child Health Hospital

  collaborator UNKNOWN

• Zhuhai Maternity & Child Healthcare Hospital

  collaborator UNKNOWN

• The First Maternity & Child Healthcare Hospital of Huizhou

  collaborator UNKNOWN

• Nanhai Women's and Children's Hospital

  collaborator UNKNOWN

• Jiangmen Maternity & Child Health Care Hospital

  collaborator UNKNOWN

• The Third Affiliated Hospital of Southern Medical University

  collaborator OTHER_GOV

• Southern Medical University, China

  collaborator OTHER

• Zhongshan Dongsheng hospital

  collaborator UNKNOWN

• Xiaolan People's Hospital of Zhongshan

  collaborator UNKNOWN

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• Baoan District People's Hospital of Shenzhen

  collaborator UNKNOWN

• Zengcheng District People's Hospital of Guangzhou

  collaborator UNKNOWN

• Dongyu Wang

  lead OTHER

Principal Investigators

• Zilian Wang, M.D.,PhD · Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Max Age

47 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• China

Study Locations