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Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT02861482
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : December 16, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou Women and Children's Medical Center
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
The Third Affiliated Hospital of Southern Medical University
Southern Medical University, China
Zhongshan Dongsheng hospital
Xiaolan People's Hospital of Zhongshan
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Baoan District People's Hospital of Shenzhen
Zengcheng District People's Hospital of Guangzhou
Information provided by (Responsible Party):
Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University

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.


Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage
Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Blood loss after Bakri Ballon temponade [ Time Frame: from using Bakri Ballon Temponade to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs ]

Secondary Outcome Measures :
  1. Ratio of Bakri Ballon only without other invasive measures in succeeding controlling PPH to the number of cases [ Time Frame: From delivery to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861482


Locations
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China, Guangdong
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Dongyu Wang
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou Women and Children's Medical Center
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
The Third Affiliated Hospital of Southern Medical University
Southern Medical University, China
Zhongshan Dongsheng hospital
Xiaolan People's Hospital of Zhongshan
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Baoan District People's Hospital of Shenzhen
Zengcheng District People's Hospital of Guangzhou
Investigators
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Study Director: Zilian Wang, M.D.,PhD Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

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Responsible Party: Dongyu Wang, M.D., First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02861482     History of Changes
Other Study ID Numbers: 2015COOK
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University:
PPH, Bakri Ballon

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Carboprost tromethamine
Carboprost
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents