Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage
NCT ID: NCT02861482
Last Updated: 2016-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
472 participants
INTERVENTIONAL
2015-01-31
2016-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bakri Ballon
All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Balloon
Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped
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
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
Blood Product
transfusion of blood product if necessary no matter which surgical procedure has been taken
Interventions
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Bakri Balloon
Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped
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
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
Blood Product
transfusion of blood product if necessary no matter which surgical procedure has been taken
Eligibility Criteria
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Inclusion Criteria
* 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
* Impaired soft birth canal injury;
* Untreated uterine deformity;
* Definite indication for uterectomy.
19 Years
47 Years
FEMALE
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
The Third Affiliated Hospital of Guangzhou Medical University
OTHER
Guangzhou Women and Children's Medical Center
OTHER
Huadu District People's Hospital of Guangzhou
OTHER
Shenzhen Maternity & Child Healthcare Hospital
OTHER
Dongguan Maternity & Child Health Hospital
UNKNOWN
Zhuhai Maternity & Child Healthcare Hospital
UNKNOWN
The First Maternity & Child Healthcare Hospital of Huizhou
UNKNOWN
Nanhai Women's and Children's Hospital
UNKNOWN
Jiangmen Maternity & Child Health Care Hospital
UNKNOWN
The Third Affiliated Hospital of Southern Medical University
OTHER_GOV
Southern Medical University, China
OTHER
Zhongshan Dongsheng hospital
UNKNOWN
Xiaolan People's Hospital of Zhongshan
UNKNOWN
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Baoan District People's Hospital of Shenzhen
UNKNOWN
Zengcheng District People's Hospital of Guangzhou
UNKNOWN
Dongyu Wang
OTHER
Responsible Party
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Dongyu Wang
M.D.
Principal Investigators
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Zilian Wang, M.D.,PhD
Role: STUDY_DIRECTOR
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
Locations
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Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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2015COOK
Identifier Type: -
Identifier Source: org_study_id