Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861482
• Other study ID #: 2015COOK
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: December 14, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 47 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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
• Hemabate
using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon
• 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
• B-lynch Suture
One of conservative surgical procedures if Bakri Balloon didn't work
• Uterine Artery Embolization using sponges
One of conservative surgical procedures if Bakri Balloon didn't work
• Cervical cerclage
One of conservative surgical procedures if Bakri Balloon didn't work
• 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

Locations

Country	Name	City	State
China	Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (21)

Lead Sponsor

Collaborator

Dongyu Wang

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, Shenzhen Maternity & Child Healthcare Hospital, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No