Bakri Ballon-An Update
Bakri Ballon-An Update
Bakri Ballon-An Update
HEMORRHAGE- AN UPDATE
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Prepared by:
Reviewed by:
DISCLOSURE
The authors of this report have no competing interest in this subject and the
preparation of this report is totally funded by the Ministry of Health, Malaysia.
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EXECUTIVE SUMMARY
Introduction
Approximately 30% (in some countries, over 50%) of direct maternal deaths
worldwide are due to hemorrhage, mostly in the postpartum period. Most
maternal deaths due to postpartum hemorrhage (PPH) occur in low-income
countries in settings both hospital and community where there are no birth
attendants or where birth attendants lack the necessary skills or equipment to
prevent and manage PPH.
Objective/aim
From the search for evidence in available scientific database and other website,
there were 15 observational studies retrieved from year 2007-2012 which were
not included in earlier report. Among these studies, 6 were full text articles and 9
were abstracts. In addition, one abstract was given by an O&G specialist from
Ministry of Health (personal communication).
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Efficacy/Effectiveness
Safety
No adverse event was reported in five studies on the use of Bakri Balloon
Tamponade in the management of postpartum hemorrhage. However, there was
one abstract reported on fever and non-febrile major complications in patients
using Bakri Balloon Tamponade alone or as in combination. Close monitoring
should be performed by trained physician in managing the complications.
Cost/cost-effectiveness
Methods
Last search was done on 13th September 2012 and there was no limitation during
the search. Relevant articles were critically appraised using Critical Appraisal
Skills Programme (CASP) and evidence graded according to the US / Canadian
Preventive Services Task Force.
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BAKRI BALLOON TAMPONADE IN POSTPARTUM HEMORRHAGE - AN
UPDATE
1. INTRODUCTION
Approximately 30% (in some countries, over 50%) of direct maternal deaths
worldwide are due to hemorrhage, mostly in the postpartum period. Most
maternal deaths due to postpartum hemorrhage (PPH) occur in low-income
countries in settings both hospital and community where there are no birth
attendants or where birth attendants lack the necessary skills or equipment to
prevent and manage PPH.1
In the context of PPH, tamponade refers to plugging the uterus with some
type of device, normally in the form of gauze pack or a balloon catheter to
stop the flow of blood. The principles of uterine tamponade can be
accomplished in two ways:
2. OBJECTIVE
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The objective of the technology review was to assess the safety,
efficacy/effectiveness and cost-effectiveness of Bakri Balloon Tamponade in
the management of postpartum hemorrhage.
3. TECHNICAL FEATURES
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4. METHODS
4.1. Searching
Other databases
PubMed
In addition, other search engine such as Google was used to search for
additional web based-materials and information. Additional articles such as
from reviewing the bibliographies of retrieved articles were also included.
4.2. Selection
A reviewer screened the titles and abstracts against the inclusion and
exclusion criteria and then evaluated the selected full-text and abstract
articles for final article selection.
Inclusion criteria
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Population Postpartum hemorrhage
Comparators None
Exclusion criteria
From the search for evidence in available scientific database and other
website, there were 15 observational studies retrieved from year 2007-2012
which were not included in earlier report. Among these studies, 6 were full text
articles and 9 were abstracts. In addition, one abstract was given by an O&G
specialist from Ministry of Health (personal communication).
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Department of Obstetrics and Fetal Medicine, University Medical Center
Hamburg-Eppendorf Hamburg Germany, The objective of the study is to
evaluate intrauterine balloon tamponade with or without B-Lynch sutures in
avoiding postpartum hysterectomy. All the patients were kept under constant
surveillance and decision for intensive care treatment was made according to
the cardiovascular and respiratory status of the patient. From 20 cases which
Bakri Balloon was the first choice to stop hemorrhage, 60 %( n=12) were
successfully treated with the balloon alone and 30% (n=6) with the balloon
and the B-Lynch sutures. Therefore, a total of 18 cases (90%) were
successfully treated with the balloon as part of the treatment.4 Level II-3
10
Gronvall M et al reported in a retrospective case series of 50 cases from
Department of Obstetrics and Gynecology Helsinki University that the overall
success rate of Bakri Balloon Tamponade was 86% (43/50). However, seven
patients (14%) needed additional procedures with four cases required
supravaginal uterine amputation or hysterectomy and embolization of the
uterine arteries in another three cases.10
Sage YH et al showed in their cohort study on the use of Bakri Balloon for
post partum hemorrhage with and without concomitant arterial embolization.
68 patients with transfusion-requiring PPH and treated with Bakri Balloon
Tamponade between 2007 and 2009 were included in this study. Five patients
(7%) had continued hemorrhage requiring immediate laparotomy. Of the 63
stabilized patients, twenty patients underwent uterine artery embolization
(UAE) while 42 patients were expectantly managed (EM). Three patients
(7%) of those 42 patients treated expectantly had recurrent hemorrhage after
the balloon was removed while none bled after UAE.12
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There was also an abstract of a retrospective case series of 25 patients using
Bakri Postpartum Balloons at Sabah Women‟s and Children‟s Hospital
(SWACH)by Loh YL et al to review the use of intrauterine tamponade using
Bakri Postpartum Balloons in the management of postpartum hemorrhage.
The data was collected from the hospital records. The causes of postpartum
hemorrhage (PPH) were uterine atony (15 cases), morbidly adherent placenta
including placenta accrete and increta (five cases), abruption placenta (one
case), miscarriage (one case), cervical ectopic (one case), uterine inversion
(one case) and idiopathic thrombocytopenic purpura (one case). The findings
showed that PPH was controlled in 18 of 25 cases (72%). All the 7 cases with
failed tamponade had massive PPH (blood loss of 1500ml or more), with 5
underwent hysterectomy (one death) and two maternal deaths. It has also
been highlighted by the author that a marked reduction was observed in the
hysterectomy rate 13.6% in 2011 as compared to 24.4% in 2010 which was
claimed to be contributed by the use of the balloon.14
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uterine atony (12 cases), placenta accrete (three cases), placenta previa (two
cases), manual removal of placenta without any placental abnormality (one
case) and no identifiable risk (one case). The findings showed that SOS Bakri
Balloon was successful in stopping hemorrhage in 16 cases and failed to
control bleeding in three cases. These three patients require a
hysterectomy.19
5.2 SAFETY
5.3 COST/COST-EFFECTIVENESS
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There was no retrievable scientific evidence addressing the cost-effectiveness
of Bakri Balloon Tamponade in the management of post partum hemorrhage.
However, as reported in the earlier report, the balloons in descending order
of relative cost was Sengstaken-Blakemore tube, Bakri balloon, Rusch
balloon, Foleys catheters and condom catheter balloon.
5.4 LIMITATIONS
6. CONCLUSION
6.1. EFFICACY/EFFECTIVENESS
6.2. SAFETY
No adverse event was reported in five studies on the use of Bakri Balloon
Tamponade in the management of postpartum hemorrhage. However, there
was one abstract reported on fever and non-febrile major complications in
patients using Bakri Balloon Tamponade alone or as in combination. Close
monitoring should be performed by trained physician in managing the
complications.
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6.3. COST/COST-EFFECTIVENESS
7. REFERENCES
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10. Gronvall M, Tikkanen M, Tallberg E et al. Use of Bakri Balloon Tamponade in
the treatment of postpartum hemorrhage; A series of 50 cases from a tertiary
teaching hospital.Acta Obstetricia Gynecologica Scandinavia© 2012 Nordic
Federation of Societies of Obstetrics and Gynecology.2012;91(Suppl 159):12-
149.
11. Bui C, Laas E, Popowski T et al. Evolution of the invasive procedures rate
after the addition of Bakri Balloon as the first second-line therapy in a protocol
of severe PPH management. American Journal of Obstetrics & Gynecology.
Jan 2012 (Suppl):S59.
12. Sage YH, Carusi D. Use of the Bakri Balloon for postpartum hemorrhage, with
and without concomitant arterial embolization.. American Journal of Obstetrics
& Gynecology. Jan 2011(Suppl):S83.
14. Loh YL, Lim C, Soon R. Bakri Postpartum Balloon In The Management of
Postpartum hemorrhage in sabah Women‟s and Children‟s Hospital
(SWACH): A Sabah Experience.
15. Kwon HY, Chung SM, Son HY et al.Bakri Balloon Tamponade in post partum
hemorrhage: A series of 37 cases. Division of Maternal-Fetal Medicine,
Department of Obstetrics and Gynecology, Yonsei University College of
Medicine, Yonsei University Health System, Seoul Korea.
19. Brassard G and Corbett T. The effectiveness of the SOS Bakri Balloon in
controlling post partum hemorrhage unresponsive to medical therapy in a
community in Edmonton, Alberta.International Journal of Gynecology and
Obstetrics. October 2009;107(S133-S134),0020-7292 (October 2009)
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20. Queensland Maternal & Neonatal Clinical Guidelines Primary postpartum
haemorrhage. Available at :
http://www.health.qld.gov.au/qcg/documents/g_pph5-0.pdf Accessed on 15th
August 2012.
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8. APPENDIX
1. Postpartum hemorrhage
2. Delayed postpartum hemorrhage.tw.
3. Immediate postpartum hemorrhage.tw.
4. Balloon occlusion
5. Uterine balloon tamponade/ uterine balloon tamponade*.tw.
6. Balloon tamponade*.tw.
7. Embolization*balloon.tw.
8. Bakri Balloon tamponade
9. 1 or 2 or 3
10. 4 or 5 or 6 or 7 or 8
11. 9 and 10
OTHER DATABASES
EBM Reviews - Cochrane Same MeSH, keywords, limits used as per
Central Register of MEDLINE search
Controlled Trials
EBM Reviews - Cochrane
database of systematic
reviews
EBM Reviews - Health
Technology Assessment
PubMed
NHS economic
evaluation database
Google Scholar Bakri Balloon Tamponade
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8.2. Appendix 2
II-3 Evidence obtained from multiple time series with or without the intervention.
Dramatic results in uncontrolled experiments (such as the results of the
introduction of penicillin treatment in the 1940s) could also be regarded as this
type of evidence.
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