Postpartum HemorrhageNCT02861482
Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage
A study testing Bakri Balloon, Oxytocin and Hemabate in people with Postpartum Hemorrhage, run by Dongyu Wang at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 19 to 47 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Bakri Balloon, Oxytocin and Hemabate
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Bakri Balloon, Oxytocin, Hemabate, Duratocin, Uterine Massage
- Keywords
- PPH, Bakri Ballon
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bakri BalloonDevice
Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped
OxytocinDrug
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
HemabateDrug
using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon
DuratocinDrug
using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon
Uterine MassageProcedure or surgery
continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon
B-lynch SutureProcedure or surgery
One of conservative surgical procedures if Bakri Balloon didn't work
Uterine Artery Embolization using spongesProcedure or surgery
One of conservative surgical procedures if Bakri Balloon didn't work
Cervical cerclageProcedure or surgery
One of conservative surgical procedures if Bakri Balloon didn't work
HysterectomyProcedure or surgery
Hysterectomy with all the above measures not working
Blood ProductDrug
transfusion of blood product if necessary no matter which surgical procedure has been taken
| Study group | Role | What they receive |
|---|---|---|
| Bakri Ballon | Experimental | All the enrolled patients who would undergo the laying of Bakri Balloon Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss after Bakri Ballon temponade
Measured: from using Bakri Ballon Temponade to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs
Secondary outcomes (1)
Ratio of Bakri Ballon only without other invasive measures in succeeding controlling PPH to the number of cases
Measured: From delivery to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongyu Wang
- Sponsor type
- University, hospital or other
- 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 and 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, Shenzhen Baoan District People's Hospital, Zengcheng District People's Hospital of Guangzhou
- Responsible party
- Sponsor-investigator, Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zilian Wang, M.D.,PhD, Study director, Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861482
- Sponsor's protocol ID
- 2015COOK
- Status last verified
- Dec 2016
- First submitted
- 15 Jun 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT02861482
- Acronym / sponsor ID
- 2015COOK
- Conditions
- Postpartum Hemorrhage
- Keywords
- PPH, Bakri Ballon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Dongyu WangUniversity, hospital or other
- 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 and 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, Shenzhen Baoan District People's Hospital, Zengcheng District People's Hospital of Guangzhou
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bakri Ballon | Experimental | 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 ProductAll the enrolled patients who would undergo the laying of Bakri Balloon |
Who may qualify
- Ages
- 19 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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);
- Signing the informed consents;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bakri BalloonGradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped | Device | Bakri Ballon |
| Oxytocinusing 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 | Bakri Ballon |
| Hemabateusing Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon | Drug | Bakri Ballon |
| Duratocinusing Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon | Drug | Bakri Ballon |
| Uterine Massagecontinuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon | Procedure or surgery | Bakri Ballon |
| B-lynch SutureOne of conservative surgical procedures if Bakri Balloon didn't work | Procedure or surgery | Bakri Ballon |
| Uterine Artery Embolization using spongesOne of conservative surgical procedures if Bakri Balloon didn't work | Procedure or surgery | Bakri Ballon |
| Cervical cerclageOne of conservative surgical procedures if Bakri Balloon didn't work | Procedure or surgery | Bakri Ballon |
| HysterectomyHysterectomy with all the above measures not working | Procedure or surgery | Bakri Ballon |
| Blood Producttransfusion of blood product if necessary no matter which surgical procedure has been taken | Drug | Bakri Ballon |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zilian Wang, M.D.,PhD study director
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bakri Balloon, Oxytocin and Hemabate in people with Postpartum Hemorrhage, run by Dongyu Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.