The Journal of Maternal-Fetal & Neonatal Medicine

ISSN: 1476-7058 (Print) 1476-4954 (Online) Journal homepage: http://www.tandfonline.com/loi/ijmf20

Bakri balloon versus condom-loaded Foley’s

catheter for treatment of atonic postpartum
hemorrhage secondary to vaginal delivery: a
randomized controlled trial

Atef M. Darwish, Mohamed M. Abdallah, Omar M. Shaaban, Mohammed K.

Ali, Mohamed Khalaf & Ali Mohamed A. Sabra

To cite this article: Atef M. Darwish, Mohamed M. Abdallah, Omar M. Shaaban, Mohammed
K. Ali, Mohamed Khalaf & Ali Mohamed A. Sabra (2017): Bakri balloon versus condom-
loaded Foley’s catheter for treatment of atonic postpartum hemorrhage secondary to vaginal
delivery: a randomized controlled trial, The Journal of Maternal-Fetal & Neonatal Medicine, DOI:
10.1080/14767058.2017.1297407

To link to this article: http://dx.doi.org/10.1080/14767058.2017.1297407

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Published online: 08 Mar 2017.

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THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE, 2017
http://dx.doi.org/10.1080/14767058.2017.1297407

ORIGINAL ARTICLE

Bakri balloon versus condom-loaded Foley’s catheter for treatment of atonic

postpartum hemorrhage secondary to vaginal delivery: a randomized
controlled trial
Atef M. Darwish, Mohamed M. Abdallah, Omar M. Shaaban, Mohammed K. Ali, Mohamed Khalaf and
Ali Mohamed A. Sabra
Woman’s Health University Hospital, Assiut University, Assiut, Egypt

ABSTRACT ARTICLE HISTORY

Objective: To assess the efficacy and safety of condom-loaded Foley’s catheter versus Bakri Received 1 January 2017
Balloon in the management of primary atonic post partum hemorrhage (PPH) secondary to vagi- Revised 7 February 2017
nal delivery. Accepted 16 February 2017
Study design: This study was single blinded randomized controlled trial conducted at Assiut
Woman’s Health Hospital, Egypt in the period between October 2014 and December 2015. It KEYWORDS
Comprised 66 women with primary atonic PPH following vaginal delivery. Eligible participants Bakri balloon tamponade;
were randomly assigned to Bakri balloon (group A) or condom-loaded Foley’s catheter (group B). Foley catheter tamponade;
The primary outcome was the success of tamponade to stop the uterine bleeding without add- postpartum hemorrhage;
itional surgical interventions. Secondary outcomes included time between insertion and stop- postpartum hemorrhage
page of the bleeding, the amount of blood transfusion and maternal complications. management
Results: Both treatment modalities successfully controlled the primary atonic PPH without a stat-
istically significant difference [30/33(91.0%) and 28/33(84.84%), p ¼ .199; respectively]. However;
Bakri balloon required shorter time to stop the uterine bleeding (9.09 min vs. 11.76 min, p ¼ .042;
respectively). There was no statistically significant difference between both groups regarding
postpartum maternal complications, the vital signs, urine output, hemoglobin and hematocrit
levels from before to after tamponade insertion.
Conclusions: Condom-loaded Foley’s catheter is as effective as Bakri balloon in the management
of primary atonic PPH following vaginal delivery but requires a significant bit longer time to
stop the attack.

Introduction balloon tamponade as an alternative method that

Post-partum hemorrhage (PPH) is an obstetric emer-
gency that may develop after vaginal or cesarean deliv-
ery [1]. It may be followed by serious complications like
hypovolemic shock, renal impairment and blood coagul-
opathy [2]. Moreover, it is one of important causes of
maternal mortality in both developing and developed
countries (1 in 1000 births versus 1 in 100,000) [3].
Previous studies proved the effectiveness of uterine
balloon tamponades (UBT) such as Foley’s catheter,
Sengstaken–Blakemore esophageal tube, the Rusch
balloon, condom balloon and the Bakri balloon in
management of PPH [4].
The World Health Organization (WHO), the
International Federation of Gynecology and Obstetrics
(FIGO), the American College of Obstetricians and
Gynecologists (ACOG) and the Royal College of
Obstetricians and Gynecologists (RCOG) considered
could considerably manage uncontrolled PPH in the
developing countries [5].
A recent systematic review included 13 non-
randomized studies, which used different types of tam-
ponade (not including Bakri balloon), reported success
rate as high as 97.0% [6]. Nevertheless, randomized
controlled trials (RCTs) between different types of
intrauterine tamponades are missing. Bakri balloon is a
famous tamponade method with excellent results [7].
Since it is a single-use expensive catheter solely
produced by one company, its main disadvantages are
high price and unavailability in every labor word. At
our institution, we are confronted with many cases of
PPH, so availability of an intrauterine tamponade is
badly needed all the time. This study aims to test the
efficacy and safety of a low-cost hand-made condom-
loaded Foley’s catheter versus Bakri balloon in the
management of atonic PPH after vaginal delivery.

CONTACT Atef M. Darwish atef_darwish@yahoo.com Department of Obstetrics and Gynecology, Woman’s Health University Hospital, P.O. Box: (1),
Assiut 71111, Egypt
ß 2017 Informa UK Limited, trading as Taylor & Francis Group
2 A. M. DARWISH ET AL.
Materials and methods
The current study is a clinically registered single-
blinded RCT (NCT02430155) comparing the effect of
condom-loaded Foley’s catheter (CLFC) and Bakri bal-
loon (BB) in management of atonic primary PPH after
vaginal delivery. The ethical review board of the
Faculty of Medicine of the Assiut University approved
the study. It was carried out in the period between
the first of October 2014 and the first of December
2015. This trial was designed and reported according
to the revised recommendations of ClinicalTrials.gov
for improving the quality of reporting RCTs.
Eligible participants
The participants were recruited from the Labor Ward of
the Woman’s Health Hospital, Assiut University, Egypt.
All women who delivered vaginally in the Labor Ward
and developed primary atonic PPH were initially man-
aged according to our hospital protocol by uterine mas-
sage and 40 IU of oxytocin (Sandoz, Cairo, Egypt)
infused in 500 ml of 5% glucose. One thousand micro-
gram misoprostol (five tablets of Misotac, Sigma Co.,
Cairo, Egypt) were inserted rectally as a further manage-
ment if the bleeding continued [8]. Those women, who
did not respond to the mentioned line of treatment,
were recruited in this study after consenting for
participation.
Women with traumatic PPH, women delivered by
cesarean section, women with abruption placenta or
placenta previa, chorioamnionitis, pregnancy compli-
cated by preeclampsia, diabetes, anemia, rheumatic
heart disease or women known to have coagulation
defects were excluded from this study.
Randomization
Randomization was done using a computer-generated
random table. Eligible patients were randomly
assigned to use BB (Group A) or CLFC (Group B).
Allocation concealment was done using serially num-
bered closed opaque envelopes. Each envelope had a
serial number and had a card noting the intervention
type. Allocation was never changed after opening the
closed envelopes.
Intervention
First-aid measures (application of two large bore can-
nulas and insertion of a urinary catheter, IV crystalloids
and colloids, preparation of cross matched blood,
blood sampling for investigations and good
monitoring) were immediately started [8]. In the case
of intractable bleeding, the patients were transferred
from the normal vaginal delivery room into the operat-
ing room.
Under general anesthesia, traumatic lesions and
placental remnants were properly excluded. Eligible
participants were allocated to one of two groups.
Group A was managed by using BB (Cook Medical,
Bloomington, IN). The BB is connected to 24 French,
54 cm long silicone catheter (Figure 2). The BB was
well-inserted inside the uterine cavity. After proper
positioning, the balloon was initially inflated with
150 mL of sterile normal saline. Then, the surgeon
put his thumb and index finger around the cervix to
keep the partially inflated balloon above the cervix.
BB was further inflated up to 400–500 mL until the
blood draining through catheter is considerably
decreased.
Group B was managed by using CLFC. The con-
dom catheter was assembled by the investigator at
the point of use and consists of readily available
components (male latex condom, an 18 rubber cath-
eter, and a string to tie the condom to the rubber
tube, sterilized by ethylene oxide gas before use)
(Figure 2). After proper positioning, the balloon was
initially inflated with 150 mL of sterile normal saline
and the surgeon ensured the proper placement then
inflated it up to 400–500 mL until the stoppage of
bleeding.
In both groups, a vaginal packing was placed using
20 cm gauze to prevent expulsion of the balloon [4].
The already inserted Foley’s catheter fixed into the
bladder was kept in place to allow complete bed rest
and avoid full bladder as a risk factors of PPH.
Balloon failure was considered if the bleeding did
not stop within 15 min after proper balloon application
[2]. Further management of the patients according to
the hospital protocol included surgical interventions to
stop the current attack of bleeding.
Study outcome
The primary outcome of this study was the success of
tamponade to stop the uterine bleeding without any
need for surgical intervention. Secondary outcomes
included the time in minutes between starting inser-
tion of balloon and stoppage of the current bleeding
attack, amount of blood transfusion, referral to inten-
sive care unit (ICU), and development of disseminated
intravascular coagulopathy (DIC) and postpartum fever
(fever 38  C during the first 24 h). The difference of
hemodynamics in patients before and after balloon
insertion was also observed.

Follow-up schedule
All patients were given analgesia (Ketolac 30 mg,
Ketorolac tromethamine; Amriya Pharmaceutical
Industries, Alexandria, Egypt) every 12 h and maintained
on IV antibiotics (Cephradine, Velosef 1 g; Glaxo Smith
Kline, New Cairo, Egypt) every 12 h and oxytocin (20 IU
infused in 500 ml of 5% glucose) every 6 h for 24 h post-
balloon application. Blood pressure, pulse, temperature,
urine output, uterine muscle contraction and active
vaginal bleeding were meticulously monitored. In both
groups, the balloon tamponade was removed after 12 h.
Firstly, the vaginal pack was removed then balloon was
gradually deflated 100 ml/15 min as a test for efficacy.
Patients were followed up for 2 h after balloon removal
for any sign of active bleeding.
Sample size
Sample size calculation was based on the primary out-
come (success to stop the primary PPH attack without
any need for surgical intervention). Previous studies
reported that BB successfully treated primary PPH in
60% of cases [9,10] while CLFC reported to be suc-
cessful in 90% of cases [4,11]. Using two-sided Chi-
square test with a ¼ 0.05, a minimum sample size of at
least 66 patients (33 patient in each study group),
using 80% power to detect 50% difference between
Figure 1. The study flow chart.
THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE 3
any of the two groups (odds ratio of 1.5) (EPi-InfoTM,
Centers for Disease Control and Prevention (CDC),
Atlanta, Georgia; 2012).
Statistical analysis
Data were collected and entered on Microsoft access
database to be analyzed using the Statistical Package
for Social Science (SPSS Inc., Chicago, IL; version 21).
The test of normality was firstly done. Comparisons
between the groups were done using Student’s t-test
to compare the mean values between groups in
scale variables. However, Chi-square tests were used to
compare the dichotomous and ordinal variables in
the groups. For analysis, p  .05 was considered
significant.
Results
Out of 100 patients with primary atonic PPH, only 66
women were eligible to participate. The main reasons
for exclusion were either not willing to share in an
RCT (20 patients) or had no reason for declining to
participate (14 patients) as shown in the study flow-
chart (Figure 1).
Basal characteristics of the study participants are
demonstrated in Table 1 and showed that both study
groups were homogenous as regard mean age, BMI,
4 A. M. DARWISH ET AL.

Figure 2. (A) Sterilized CLFC and (B) inflated CLFC.

Table 1. Baseline characteristics and delivery data of the respectively). Five cases in CLFC group, balloon rupture
participants. occurred after inflation which was managed by imme-
Group A BB Group B CLFC diate reinsertion of another CLFC. BB needed a signifi-
Characteristics (n ¼ 33) (n ¼ 33) p value
cantly shorter time to stop the current bleeding attack
Age (years)a 28.64 ± 6.43 27.00 ± 4.81 .377
Body mass index (kg/m2)a 27.17 ± 6.85 27.53 ± 7.22 .787 as compared to CLFC (9.09 and 11.76 min, respectively)
Paritya 2.97 ± 2.24 2.91 ± 1.96 .880 (p ¼ .042) (Table 2).
b
Number of previous abortions 6 (18.1) 8 (24.2) .786
Number of living children a
2.76 ± 1.82 2.94 ± 1.78 .599 Two cases (6.6%) in BB group and two cases
Number of previous CSb 14 (42.2) 11 (33.3) .671 (14.2%) in CLFC group were transferred to ICU after
Gestational age (weeks)a 37.64 ± 2.69 37.94 ± 3.00 .427
EFW (grams) a
3024.24 ± 811.26 3063.64 ± 717.56 .658 insertion of tamponade because they were clinically
History of previous APHb 4 (12.1) 2 (6.1) .669 unstable and requiring continuous monitoring and fre-
History of previous PPHb 10 (30.3) 12 (36.3) .314
a quent observation than can be safely provided on the
Data are expressed as mean ± standard deviation.
b
Data are expressed as number (%). ward (Table 2). About 98% of women subjected to bal-
APH: antepartum hemorrhage; EFW: estimated fetal weight. loon tamponade were received blood transfusion
(mean ± standard deviation (SD) amount of needed
parity, number of previous abortions, number of living blood in units is 2.52 ± 1.39)
children, number of previous CS, gestational age, esti- As regard postpartum fever, one case developed
mated fetal weight and percentage of previous history fever in BB and two cases in group CLFC. There were
of ante-partum or PPH. no statically significant differences between both
The mean age of the study participants was groups as regard need for blood transfusion, ICU
28.0 years with a mean body mass index (BMI) of admission, DIC development and postpartum fever
27.35. Moreover, the mean parity of the participants (p ¼ .523, p ¼ .374, p ¼ .642 and p ¼ .15, respectively)
in the study was 3.0. (Table 2).
Thirty patients (91.0%) were successfully treated by There was no statistically significant difference
BB while 28 (84.84%) women were treated by CLFC between both groups regarding pulse rate, systolic
without reported interventional complications related and diastolic blood pressure, urine output, hemoglobin
to the technique of tamponade insertion. BB failed to and hematocrit levels from before to after intervention
control the uterine bleeding in three patients; two of (Table 3).
them were managed by B-Lynch and the remaining
one was subjected to immediate peri-partum hysterec-
Discussion
tomy. CLFC failed to control the uterine bleeding in
five patients; three of them were managed by B-Lynch PPH is a serious event associated with high percentage
and the other two patients were subjected to immedi- of maternal morbidity and mortality [12–14].
ate peri-partum hysterectomy (Table 2). Tamponade of the uterus can be used for those who
There was no significant difference between both do not respond to uterotonics or if uterotonics are not
groups as regard the surgical intervention following available. This procedure may potentially save the
failure of balloon tamponade (p ¼ .559 and p ¼ .098, patients from surgical intervention and is the
 THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE 5

Table 2. The main study outcomes.

Group A BB Group B CLFC
Outcomes (n ¼ 33) (n ¼ 33) p value
Required surgical intervention, n (%) 3 (9.0%) 5 (15.2%) .199
Successful procedure, n (%)
B-Lynch 2 (6%) 3 (10.7%) .559
Hysterectomy 1 (3%) 2 (7.14%) .098
Time between starting insertion of balloon and stoppage 9.09 ± 6.06 11.76 ± 7.23 .042b
of bleeding, mean ± SDa
Need of blood transfusion, n (%)a 29 (96.6%) 28 (100%) .523
Referral to ICU, n (%)a 2 (6.66%) 4 (14.2%) .374
Development of DIC, n (%)a 1 (3.33%) 2 (7.1%) .642
Post insertion fever, n (%)a 2 (6.66%) 1 (3.5%) .15
a
The secondary outcomes data are only for those women who were successfully treated by balloon tamponade and did
not include those who had treatment failure.
Statistically significant difference (p < .05).

Table 3. Hemodynamic for patients before and after tampon- management of atonic PPH in 80.0% of cases which
ade insertion. may be attributed to small sample size of their study
Group A BB Group B CLFC (15 cases only). For instance, a effectiveness rate reach-
Hemodynamic (n ¼ 33) (n ¼ 33) p value ing 93.6% among 109 cases who were delivered
Before intervention
Pulse rate (b/min) 109.24 ± 8.30 107.26 ± 7.21 .085
either vaginally or by cesarean section with atonic
Systolic BP (mmHg) 99.39 ± 10.29 102.19 ± 8.70 .145 PPH, placenta previa, placenta increta or scared uterus
Diastolic BP (mmHg) 61.82 ± 8.46 64.69 ± 8.03 .368
Urine output (mL/h) 68.18 ± 51.26 81.82 ± 44.75 .184
[21]. Another study reported that BB was effective to
Hemoglobin (g/dL) 10.20 ± 1.07 10.54 ± 0.83 .241 stop the bleeding in 100% of cases provided that the
Hematocrit (%) 33.95 ± 3.05 33.15 ± 3.88 .396
After intervention
amount of bleeding was <1000 mL at time of recruit-
Pulse rate (b/min) 89.64 ± 7.70 90.42 ± 11.73 .634 ment [22].
Systolic BP (mmHg) 119.70 ± 7.28 119.39 ± 7.04 .964 Since its introduction for treatment of atonic PPH
Diastolic BP (mmHg) 76.36 ± 7.83 78.48 ± 9.06 .342
Urine output (mL/h) 269.70 ± 166.74 250.00 ± 63.74 .622 [16], the effectiveness of CLFC has been tested with
Hemoglobin (g/dL) 8.37 ± 1.32 8.61 ± 1.46 .315 variable degrees of success ranged from 86.0 to
Hematocrit (%) 27.47 ± 4.42 28.28 ± 3.94 .641
BP: blood pressure.
100.0% in many prospective and retrospective studies
These data are only for those women who were successfully treated by [23–27]. In prospective non-randomized studies
balloon tamponade and did not include those who had treatment failure.
[28,29], CLFC was effective to control the atonic PPH
appropriate measure while transferring the patients to by 95.0 and 90.4%, respectively, which may be attrib-
a higher-level facility [15]. CLFC is an interesting tam- uted to large sample size of both studies (201 and 139
ponade firstly described by Akhter et al. [16] and cases, respectively).
achieved success rate of 100.0%. The safety aspect of the UBT was a challenging
The present work, firstly, showed the efficacy of BB aspect. The theoretical, early or late, complications
(91.0%) and CLFC (85.0%) in cessation of the bleeding that may exist in association with balloon usage such
secondary to uterine atony after vaginal delivery, there as uterine perforation, uterine rupture and postpartum
was insignificant difference between both groups endometritis, had not occurred in our study. Most of
regard the efficiency. The effectiveness of BB, in this the published work on postpartum use of intrauterine
current work, is in accordance with those of Alkış et al. tamponade was performed in developing countries
[17], who reported success of BB in management of where essential life-saving instrumentation and tools
PPH in 91.4% of cases. However; uterine atony in their are liberally available regardless cost. BB is a single-use
study represented only (43%) of cases in contrast to expensive effective intrauterine tamponade. To ensure
this study where all cases had atonic PPH. patient’s safety, ethical committee of our institution
The effectiveness of BB in stopping atonic PPH in prohibits reuse of any disposables due to high preva-
the current study was superior to that was reported lence of hepatitis B and C in our community.
by Cho et al. [9], Alouini et al. [18] and Kumru et al. Moreover, safety of re-sterilization in such bloody
[19] who reported success rate of 75.0, 88.0 and 88.0, procedure is very doubtful. On the other hand, CLFC is
respectively. Unlike their studies, exclusion of non- a disposable device for single use that ensures safety.
atonic PPH and placenta previa may explain higher The cost of BB at our country equals 2700 EP
success rate of this study. while the cost of a single set of CLFC is just 10 EP.
However, Vitthala et al. [20] included only atonic This huge difference makes CLFC is an attractive alter-
PPH, but they reported that BB was effective in native if cost of medical care is a matter of interest.
6 A. M. DARWISH ET AL.
This is evident in developing countries with limited
resources. This huge difference in price stands behind
omission of cost effectiveness study between both
balloons.
Condom has a thin wall that may adapt the uterine
cavity in a better way than BB. Moreover, it can
accommodate >500 cc of saline whenever needed.
However, being thinner than BB makes it liable to rup-
ture in certain situations as reported in this study in
five cases. However, a double condom can help min-
imize this accident and still reinsertion of another
CLFC is an option before surgical intervention.
In this RCT, BB was statistically more effective with
shorter time needed for stoppage of the current attack
of bleeding than CLFC. Softness of the martial from
which condoms are made may be the reason behind
that difference. Soft material in condom may need
more time to make its compression effect. One of the
previous studies reported as short time of two minutes
was needed to stop the current attack of bleeding
[20]. Our results agreed with other studies reported
stoppage of bleeding with CLFC within 10 minutes
after insertion [23,25]. On the other hand, Gurung
et al. [30] reported stoppage of bleeding immediately
after insertion. However, in other studies CLFC
required >15 min to stop bleeding [6,26]. Despite
being statistically significant difference in this study,
the very low price of CLFC may outweigh this disad-
vantage if compared to BB.
Secondary to the comparable effect of both tam-
ponade devices, the vital signs of the studied women
were improved greatly in both groups from before to
after the intervention without statistical significant dif-
ference due to successful effect of BB and CLFC on
stoppage of bleeding. However, hemoglobin and hem-
atocrit level decreased significantly in both groups
after intervention. Unsurprised observation resulting
from considerable hemorrhage before the
intervention.
Limitations of the current study are small sample
size that sited to estimate big deference between the
two types of intervention with masking a small differ-
ence that may appear when a bigger sample simple
size. We excluded cases with placenta previa, pree-
clampsia, diabetes mellitus, rheumatic heart disease
and cases with coagulation defects despite being
approved by our institution as indications for BB use if
atonic PHH develop. Exclusion of these cases was
done to avoid heterogeneity of cases and subsequent
week results. Failure to use an accurate measure of
blood loss estimation in patients and relying on indir-
ect methods of estimation like HB before and after the
intervention is a weak point of this study. We did not
report the remote complications of the tamponade on
subsequent menses, fertility and pregnancies because
they were not outcome of our study. Missing cost
effectiveness evaluation of both balloons as an integral
part of this study is a real limitation.
Conclusion
Low-cost hand-made condom-loaded Foley’s catheter
is as effective as Bakri balloon in the management of
refractory primary atonic PPH following vaginal deliv-
ery but requires a significant bit longer time to stop
the attack. Its reasonable success rate and very low
price would encourage its wide use in low resource
countries where more expensive disposable tampo-
nades are not available.
Disclosure statement
The authors report no conflicts of interest. The authors
alone are responsible for the content and writing of
this article.
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