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Bakri Ballon-An Update

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BAKRI BALLOON TAMPONADE IN POSTPARTUM

HEMORRHAGE- AN UPDATE

HEALTH TECHNOLOGY ASSESSMENT SECTION


MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
019/2012
i
DISCLAIMER
Technology review is a brief report, prepared on an urgent basis, which draws on
restricted reviews from analysis of pertinent literature, on expert opinion and / or
regulatory status where appropriate. It has not been subjected to an external
review process. While effort has been made to do so, this document may not
fully reflect all scientific research available. Additionally, other relevant scientific
findings may have been reported since completion of this review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS),


Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya

Tel: 603 88831246

Fax: 603 88831230

Available at the following website: http://www.moh.gov.my

ii
Prepared by:

Ku Nurhasni binti Ku Abd Rahim


Senior Assistant Director
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

Reviewed by:

Datin Dr. Rugayah Bakri


Public Health Physician
Deputy Director
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

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.

iii
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.

Treatment options for PPH include conservative management with uterotonic


drugs, selective devascularization by ligation or embolization of the uterine
artery, external compression with uterine sutures, intrauterine packing and
peripartum hysterectomy to control life-threatening hemorrhage. Recently,
alternative procedures such as uterine compression sutures or intrauterine
balloon tamponade have gained popularity.

A technology review was conducted earlier in 2011 on Bakri Balloon Tamponade


by Malaysian Health Technology Assessment Section (MaHTAS) and was
recommended to be used for research purposes. This technology review was
requested by the Director of Medical Development Division, Ministry of Health to
review the recent evidence of Bakri Balloon Tamponade in the management post
partum hemorrhage.

Objective/aim

To assess the safety,efficacy/effectiveness and cost-effectiveness of Bakri


Balloon Tamponade in the management of postpartum hemorrhage.

Results and conclusions

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).

With regards to the effectiveness of Bakri Balloon Tamponade in the


management of postpartum hemorrhage, all 16 studies were included. 6 out of
the 16 studies were included for review on safety of Bakri Balloon Tamponade in
the management of postpartum hemorrhage.

There was no cost-effectiveness study retrieved from the scientific databases.

iv
Efficacy/Effectiveness

There was fair level of evidence on the efficacy/effectiveness of Bakri Balloon


Tamponade in the management of postpartum hemorrhage. The findings
from these studies showed a potential use of Bakri Balloon Tamponade in the
management of postpartum hemorrhage unresponsive to medical treatment.

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

The cost-effectiveness of Bakri Balloon Tamponade in the management of


postpartum hemorrhage cannot be determined as no scientific evidence was
retrieved from the scientific database. 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.

Methods

Scientific electronic databases were searched through OVID interface which


include OVID MEDLINE (R) In process &Other Non-Indexed Citations and OVID
MEDLINE (R) 1946 to present, Cochrane Central Register of Controlled Trials
July 2012, Cochrane Database of Systematic Reviews 2005 to July 2012, EBM
Reviews- Health Technology Assessment 3rd Quarter 2012, EBM Reviews- NHS
Economic Evaluation Database 3rd Quarter 2012 and Pubmed.

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.

v
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

Treatment options for PPH include conservative management with uterotonic


drugs, selective devascularization by ligation or embolization of the uterine
artery, external compression with uterine sutures, intrauterine packing and
peripartum hysterectomy to control life-threatening hemorrhage. Recently,
alternative procedures such as uterine compression sutures or intrauterine
balloon tamponade have gained popularity. 2 A variety of such balloons are
available which include Bakri balloon, Foley‟s, Condom catheters,
Sengstaken-Blakemore and Rusch balloon.

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:

1. By insertion of a balloon catheter that distends in the uterine cavity and


occupies the entire space, thereby creating an intrauterine pressure
that is greater than the systemic arterial pressure. The blood flow into
the uterus should stop when the pressure in the tamponade balloon
greater than that of the systemic arterial pressure. This effect could be
achieved in the absence of laceration.

2. By insertion of a uterine pack consisting of a gauze roll that is tightly


packed into the uterus to create a pressure which is directly applied on
capillary/venous bleeding vessels or surface oozing from within the
uterus to achieve significant reduction or stoppage of uterine bleeding.
3

A technology review was conducted earlier in 2011 on this technology by the


Malaysian Health Technology Assessment Section (MaHTAS) and was
recommended to be used for research purposes. This technology review was
requested by the Director of Medical Development Division, Ministry of Health
to review the recent evidence of Bakri Balloon Tamponade in the
management of postpartum hemorrhage.

2. OBJECTIVE

6
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

The Bakri Balloon Tamponade is 58 cm long and made of 100% silicone


material from Cook Medical. It is an inflatable balloon on a double lumen
shaft. Balloon capacity is up to maximum 800 mL. However, the
recommended use is up to 500 mL. The tip of the shaft has two holes for
drainage, so ongoing haemorrhage can be detected after application of the
balloon. The balloon should not be filled with less than 250 mL sterile saline to
achieve adequate haemostasis. The balloon is easily removed transvaginally
after deflation. The balloon can be left in place for 24 hours. If utilized during a
cesarean section procedure, the distal end of the balloon shaft is passed
through the cervical opening with an assistant pulling that end vaginally. Bakri
Balloon tamponade has obtained USFDA approval.2,3

Figure 1: Bakri Balloon Tamponade 2

7
4. METHODS

4.1. Searching

Electronic databases searched through the Ovid interface;


OVID MEDLINE (R) In process &Other Non-Indexed Citations and OVID
MEDLINE (R) 1946 to present
EBM Reviews - Cochrane Central Register of Controlled Trials- July 2012
EBM Reviews - Cochrane database of systematic reviews – 2005 - July
2012
EBM Reviews - Health Technology Assessment – 3rd Quarter 2012
NHS economic evaluation database – 3rd Quarter 2012

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.

The inclusion and exclusion criteria were:

Inclusion criteria
8
Population Postpartum hemorrhage

Interventions Bakri Balloon Tamponade

Comparators None

Outcomes 1) Reduction or stoppage of bleeding


2) Avoidance of hysterectomy and maternal deaths
Study design All

Type of English language article


publication

Exclusion criteria

Study design None

Type of Non- English language full text article,


publication Articles from year 2006 and below,
Articles included in Malaysian Health Technology
Assessment (MaHTAS) Technology Review report
(029/2011)

Relevant articles were critically appraised using Critical Appraisal Skills


Programme (CASP) and evidence graded according to the US / Canadian
Preventive Services Task Force.

5. RESULTS AND DISCUSSION

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).

With regards to the effectiveness of Bakri Balloon Tamponade in the


management of postpartum hemorrhage, all 16 studies were included. 6 out
of the 16 studies were included for review on safety of Bakri Balloon
Tamponade in the management of postpartum hemorrhage.

There was no cost-effectiveness study retrieved from the scientific databases.


5.1. EFFICACY/EFFECTIVENESS

A retrospective case series of 24 patients who were diagnosed to have severe


postpartum hemorrhage (PPH) and unsuccessful medical treatment with
uterotonic agents with 20 cases was subsequently treated with Bakri Balloon
between Jan 2005- July 2010 was conducted by Diemert A et al at

9
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

A prospective observational study of eleven women who underwent external


compression sutures in association with intrauterine Bakri Balloon
Tamponade for PPH secondary to atony (ten cases complicated by placenta
previa with one concomitant placenta accreta) was conducted by Yoong W et
al at Department of Obstetrics and Gynecology North Middlesex University
Hospital London between December 2007 and December 2009. The author
found that no additional conservative surgery or hysterectomy was necessary
and there was no postpartum morbidity observed. All the women who
attended their three-month postnatal review had resumed menstruation.5 Level
II-3

Dabelea V et al. conducted a retrospective case series of 23 patients with


postpartum hemorrhage unresponsive to medical therapy managed with
intrauterine balloon tamponade between September 2003 and September
2005 at the Department of Obstetrics and Gynecology Exempla Saint Joseph
Hospital Denver, Colorado. From the 23 cases included in the report, proper
placement was achieved in 20 cases (87%) which used Sengstaken
Blakemore tube (5 cases) and SOS Bakri Balloon (15 cases). The bleeding
was successfully controlled in 18 cases (90%) of these 20 cases. From the 18
cases which were successfully controlled using the balloon tamponade, 11
cases were with uterine atony, four patients with retained placenta, one
patient with septic shock and two patients with amniotic fluid embolism. The
intrauterine tamponade failed to control the bleeding in two patients, one with
final diagnosis of placenta previa with percreta and another patient with
severe postpartum hemorrhage with disseminated intravascular coagulation.
The balloon tamponade placements were unsuccessful in three patients, but
were considered a failure of placement, not failure of tamponade. The author
also reported that there was no difference observed in the effectiveness of
Sengstaken Blakemore tube and Bakri Balloon 6 Level II-3
There were two case reports from Spain and United Kingdom on the use of
Bakri Balloon tamponade in the management of recurrent uterine inversion.
The results found that the use of Bakri Balloon Tamponade helped to
preserve the position of the fundus and allowed the preservation of patient‟s
reproductive potential. 7,8 Level III Another case report from Canada was
published on the placement of a cervical cerclage in combination with an
intrauterine balloon catheter to arrest post partum hemorrhage. The findings
showed that the hemorrhage was abated.9 Level III

The following findings were extracted from abstract:

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

Bui C et al reported a before and after cohort study in Poissy Saint-Germain


Hospital to study the evolution of the invasive procedures rate after the
addition of Bakri Balloon as the first second-line therapy to their protocol of
severe PPH management. The author compared the outcomes of all patients
delivered vaginally with a PPH unresponsive to sulprostone during two equal
periods with similar medical management during both periods. The patients
were recruited from two different periods, one period from September 2006 to
March 2008 and another period from April 2008 to December 2010. During
the first period, if the bleeding was still not controlled and unresponsive to
sulprostone, an invasive procedure was at once performed while during the
second period, the intrauterine balloon was attempted. As presented in the
poster session the author reported that during the second period, Bakri
Balloon was used in 31 patients with success rate of 84% (26/31). The rates
of arterial embolization and conservative surgical procedures (artery ligations,
compressive uterine sutures) were significantly reduced in the second period
(8.3% vs 2.3%,p=0.006, OR 0.26, 95%CI 0.09-0.72) and (5.1%vs
1.4%,p=0.029, OR 0.26, 95% CI 0.07-0.95) respectively. No differences were
observed in the rate of hysterectomy.11

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

An abstract of retrospective case series of 42 massive postpartum


hemorrhages in University Kebangsaan Malaysia Medical Centre (UKMMC)
during the period of 27 months was conducted by Aqmar SS et al to
determine the efficacy of Bakri Balloon Tamponade in management of
obstetric hemorrhage with avoidance of hysterectomy and maternal death.
The data was collected from the delivery record, high dependency and
intensive care unit census and patient‟s medical records. 42 cases of massive
obstetrics hemorrhage were identified. 12 patients were managed by Bakri
Balloon with two cases failed the insertion of the balloon. There were eight
cases of primary PPH, one case of secondary PPH and three cases following
the early pregnancy complications. The author also reported that six cases
were complicated by DIVC and one required hysterectomy. There were no
maternal deaths reported by the author.13

11
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

An abstract of a series of 37 cases by Kwon HY et al from Yonsei University


Health System Seoul Korea reported that Bakri Balloon was effective in eight
women who delivered vaginally and 24 women who underwent caesarean
section. PPH was not controlled by the balloon in five women with three cases
undergone uterine embolization and two women underwent hysterectomy. 15

Suciu N et al conducted a retrospective study of 40 cases with severe


postpartum hemorrhage between 2006-2009 in the Obstetrics-Gynecology
Department of IOMC Polizu and found 30 cases (75%) had a complete
hemorrhagic control and 10 cases (25%) required haemostatic hysterectomy
due to insufficient hemorrhagic control by tamponade with SOS Bakri
catheter. The author also reported that for uterine atonia cases, the success
rate was high responding perfectly to balloon tamponade if this approaches
done within a proper time.16

Stavroulis A et al reported a retrospective study where the data were collected


from 30 patients who had Bakri Balloons inserted. Therapeutic Bakri balloon
was inserted in 25 patients with intractable PPH while it was inserted
prophylactically in five patients. The author found the use of Bakri Balloon in
the management of postpartum hemorrhage was successful in 23/25 cases in
the therapeutic group (92%) and failed in two patients in whom caesarean
hysterectomies were performed. Uterine compression sutures were inserted
in five patients in addition to the Bakri Balloon (uterine sandwich) for
persistent uterine atony.17 The same author also conducted a case series of 5
patients who had therapeutic intrauterine Bakri Balloon and uterine
compression sutures (uterine sandwich) inserted for intractable PPH. All five
patients had uterine atony resistant to oxytocics and in addition three of the
patients also had placenta praevia. The uterine sandwich was successful in all
five patients.18

Another retrospective case review was conducted at a community hospital in


Edmonton Alberta by Brassard et al involving 19 cases of post partum
hemorrhage that failed to respond to medical therapy. The cause of PPH was

12
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

Diemert A et al conducted a retrospective case series at Department of


Obstetrics and Fetal Medicine, University Medical Center Hamburg-Eppendorf
Hamburg Germany and reported that in overall group, no surgical
complications directly related to the Bakri Balloon or B-Lynch suture such as
endomyometritis, wound infection or fever was observed. 4 Level II-3

A prospective observational study by Yoong W et al at Department of


Obstetrics and Gynecology North Middlesex University Hospital London
between December 2007 and December 2009 found that of all the eleven
women included in the study, there was no postpartum morbidity such as
febrile episodes that was reported.5 Level II-3

The following findings were extracted from abstract:

An abstract of a retrospective case series of 50 cases from department of


obstetrics and gynecology Helsinki University hospital by Gronvall M et al on
the use of Bakri Balloon tamponade in the treatment of postpartum
hemorrhage showed that six patients developed complications but none were
related to the Bakri Balloon Tamponade. 10

Sage YH et al presented their cohort study at poster session on the use of


Bakri Balloon for postpartum hemorrhage, with and without concomitant
arterial embolization. It is reported that the rates of febrile morbidity in both
groups expectantly managed (EM) and uterine artery embolization (UAE)
were 27% and 50% respectively (RR =1.88, 95%CI =0.85-4.14). Rates of
non-febrile major complications were 9% in the EM and 25% in UAE group
(RR=2.69 95% CI=0.81-8.95). Twenty percent of UAE patients had abnormal
angiographic findings; three arterial extravasations and one pseudoaneurysm.
A low rate of abnormal angiogram was reported when the cause of bleeding
was primarily vascular or non-vascular.12

Stavroulis A et al conducted a retrospective study to evaluate the use of Bakri


Balloon Tamponade in the management of postpartum hemorrhage in 30
patients as therapeutic or prophylactic treatment and also a case series of five
patients who had uterine sandwich inserted for intractable PPH. No
complications were observed in these studies.17,18

5.3 COST/COST-EFFECTIVENESS

13
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

Selection of studies was done by one reviewer and checked by another


reviewer.
Although there was no restriction in language during the search, only
English language articles were included in this review.
Although all effort has been made to retrieve all the full text articles, we
were unable to retrieve the full text article for nine studies. Hence, the
quality of the study cannot be determined.

6. CONCLUSION

6.1. EFFICACY/EFFECTIVENESS

There was fair level of evidence on the efficacy/effectiveness of Bakri Balloon


Tamponade in the management of postpartum hemorrhage. The findings
from these studies showed a potential use of Bakri Balloon Tamponade in the
management of postpartum hemorrhage unresponsive to medical treatment.

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.

14
6.3. COST/COST-EFFECTIVENESS

The cost-effectiveness of Bakri Balloon Tamponade in the management of


postpartum hemorrhage cannot be determined as no scientific evidence was
retrieved from the scientific database. 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.

7. REFERENCES

1. FIGO Safe Motherhood and Newborn Health (SMNH) Committee.


International Journal of Gynecology and Obstetrics.2012; 117:108-118.

2. Chandriah H, Rugayah B, Jeganathan R. Bakri Balloon tamponade in post


partum haemorrhage.Putrajaya. Health Technology Assessment Section,
Medical Development Division, Ministry Of Health:2011.

3. Danso D, Reginald PW. Internal Uterine Tamponade.263-267.


Available at: www.sapienspublishing.com/pph_pdf/PPH-Chap-28.pdf.
Accessed on 10th August 2012.

4. Diemert A, Ortmeyer G, Hollwitz B et al.The combination of intrauterine


balloon tnaponade and the B-Lynch procedure for the treatment of severe
postpartum hemorrhage. American Journal of Obstetrics&Gynecology. Jan
2012; 206:65.e1-4.

5. Yoong W, Ridout A, Memtsa M et al. Application of uterine compression


suture in association with intrauterine balloon tamponade („uterine sandwich‟)
for postpartum hemorrhage. Acta Obstetricia et Gynecologica Scandinavia ©
2011 Nordic Federation of Societies of Obstetrics and Gynecology.2012;
97:147-151.

6. Dabelea V, Schultze PM, McDuffie Jr. RS.Intrauterine Balloon Tamponade in


the Management of Postpartum Hemorrhage.American Journal of
Perinatology. 2007; 24(6):359-364.

7. Elosegui JJH, Arenas FJF, Garcia AC et al. Conservative management of a


recurrent peuperal uterine inversion with bakri® balloon tamponade. Open
Journal of Obstetrics and Gynecology. 2011; 1:197-201.

8. Majd HS, Pilsniak, Reginald PW. Recurrent uterine inversion: a novel


treatment approach using SOS Bakri Balloon.BJOG.2009; 116:999-1001.

9. Jain V. Placement of cervical cerclage in combination with an intrauterine


balloon catheter to arrest post partum hemorrhage. American Journal of
Obstetrics & Gynecology. July 2011.e15-e17.

15
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.

13. Aqmar SS, Azurah NAG, Rahana AR et al.Managing massive obstetric


hemorrhage with Bakri Balloon Tamponade UKM Medical Centre Experience.
Med & Health. June 2011; 6(1)(Suppl):291.

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.

16. Suciu N, Banceanu G, Oprescu D, et al Non surgical treatment in post-partum


hemorrhage over haemostatic hysterectomy: A challenge in modern
obstetrics. Journal of Maternal-fetal and Neonatal Medicine. May 2010;
23(72):1476-7058.

17. Starvroulis A, Memtsa M, Aref-Adib M, Fakokunde A et al Management of


post partum hemorrhage with Bakri Balloon tamponade .International Journal
of Gynecology and Obstetrics. Oct 2009; 107(S348), 0020-7292(October
2009).

18. Stavroulis A, Aref-Adib M, Memtsa M et al. Combined use of Bakri Balloon


and uterine compression sutures (“uterine sandwich”) in post partum
hemerhaage: A case series of five patients. International Journal of
Gynecology and Obstetrics.2009; 10752:S93-S396.

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)

16
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.

21. South Australian Perinatal Practice Guidelines. Chapter 89 Balloon


Tamponade and uterine packing for major PPH. Available at :
www.health.sa.gov.au/PPG/Default.aspx?PagecontentMode=0αtabid=204
Accessed on 15 th August 2012.

22. Southampton University Hospital Post partum haemorrhage: Guidelines.


Available at: http://www.transfusionguidelines.org.uk/docs/pdfs/rtc-
scent_policy_southampton_pphv2.pdf. Accessed on 15 th August 2012.

23. Green Top Guideline No 52: Prevention and management of postpartum


haemorrhage. Available at: http://www.rcog.org.uk/files/rcog-
corp/GT52PostpartumHaemorrhage0411.pdf . Accessed on 13th September
2012.

17
8. APPENDIX

8.1. Appendix 1: LITERATURE SEARCH STRATEGY

Ovid MEDLINE® In-process & other Non-Indexed citations and Ovid


MEDLINE® 1946 to present

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

18
8.2. Appendix 2

HIERARCHY OF EVIDENCE FOR EFFECTIVENESS STUDIES

DESIGNATION OF LEVELS OF EVIDENCE

I Evidence obtained from at least one properly designed randomized controlled


trial.

II-I Evidence obtained from well-designed controlled trials without


randomization.

II-2 Evidence obtained from well-designed cohort or case-control analytic studies,


preferably from more than one centre or research group.

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.

III Opinions or respected authorities, based on clinical experience; descriptive


studies and case reports; or reports of expert committees.

SOURCE: US/CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris


2001)

19

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