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Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE August 10, 2016
Last Update Posted Date December 16, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Blood loss after Bakri Ballon temponade [ Time Frame: at 0.5 hour after Bakri Ballon Temponade ]
  • Blood loss after Bakri Ballon temponade [ Time Frame: at 2 hours after Bakri Ballon Temponade ]
  • Blood loss after Bakri Ballon temponade [ Time Frame: at 12 hours after Bakri Ballon Temponade ]
  • Blood loss after Bakri Ballon temponade [ Time Frame: at 24 hours after Bakri Ballon Temponade ]
Change History Complete list of historical versions of study NCT02861482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
Ratio of Oxytocin and Bakri Ballon alone without other invasive measures in succeeding controlling PPH to the number of cases [ Time Frame: From Delivery to 24 hours after Bakri Ballon Temponade ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage
Official Title  ICMJE Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2016)
472
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 47 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02861482
Other Study ID Numbers  ICMJE 2015COOK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Dongyu Wang
Collaborators  ICMJE
  • 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  ICMJE
Study Director: Zilian Wang, M.D.,PhD Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP