Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: Bakri Balloon; Drug: Oxytocin; Drug: Hemabate; Drug: Duratocin; Procedure: Uterine Massage; Procedure: B-lynch Suture; Procedure: Uterine Artery Embolization using sponges; Procedure: Cervical cerclage; Procedure: Hysterectomy; Drug: Blood Product

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.

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bakri Ballon; All the enrolled patients who would undergo the laying of Bakri Balloon

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dongyu Wang
• Collaborators: First Affiliated Hospital, 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; Sixth Affiliated Hospital, Sun Yat-sen University; Southern Medical University, China; Guangzhou Women and Children's Medical Center; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; 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; Zhongshan Dongsheng hospital; Xiaolan People's Hospital of Zhongshan; Baoan District People's Hospital of Shenzhen; Zengcheng District People's Hospital of Guangzhou
• Investigators: Study Director: Zilian Wang, M.D.,PhD, Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: PPH, Bakri Ballon
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carboprost tromethamine
• Other Study ID Numbers: 2015COOK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No