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doi:10.1111/jog.13596 J. Obstet. Gynaecol. Res.

2018

Intraluminal pressure of uterine balloon tamponade in


the management of severe post-partum hemorrhage

Choi Wah Kong and William W. K. To


Department of Obstetrics and Gynaecology, United Christian Hospital, Hong Kong

Abstract
Aim: Intrauterine balloon tamponade has been increasingly used for the management of post-partum hem-
orrhage (PPH) in recent years. However, data on the precise mechanisms and pressure required for the bal-
loon tamponade are scanty in the literature. This study aims to review the intraluminal pressure (ILP)
generated by the Bakri intrauterine balloon that is necessary to produce a ‘positive tamponade test’ during
severe PPH.
Methods: This was a prospective cohort study. The ILP of the Bakri balloon was measured using a manome-
ter after a positive tamponade test was clinically achieved during severe PPH (blood loss >1 L). The patient’s
blood pressure was recorded, and ultrasound scan was performed to verify the position of the balloon and
the presence of forward flow in the uterine arteries. The main outcome measure is the ILP of the Bakri bal-
loon required to achieve a positive tamponade test.
Results: Twenty patients were included for final analysis. The net ILP measured ranged from 67 to
92 mmHg, and this pressure was lower than the concurrent systolic pressure in all cases. Color Doppler con-
firmed positive forward flow in the uterine vessels in all cases. There were no differences in the pressure
measured with the balloon position, and there was no relationship between the volumes of saline infused
and the net pressure.
Conclusion: A positive tamponade test in an intrauterine balloon is probably achieved by local compression
pressure exerted on the vasculature of the placental bed rather than by generating an ILP exceeding systemic
blood pressure or by occlusion of flow to the uterine arteries.
Key words: balloon tamponade, post-partum hemorrhage, uterine/cervical physiology.

Introduction hysterectomy, including external compression sutures,


selective devascularization by surgical ligation or
Post-partum hemorrhage (PPH) continues to be one radiological embolization of the uterine and pelvic
of the leading causes of maternal mortality.1 Severe arteries.3 Traditionally, uterine packing has been
PPH has been variously defined as blood loss employed as a method to control PPH by direct pres-
between 1000 and 2000 mL or above.2 A peripartum sure effects.4 The use of the uterine-specific Bakri
hysterectomy should be performed in patients with intrauterine balloon tamponade (IUBT) for the treat-
severe PPH as a life-saving rescue procedure in those ment of obstetric hemorrhage with low-lying placen-
who failed to respond to uterotonics. However, due tae during cesarean delivery was first published in
to the high morbidity associated with peripartum hys- 1992.5 Other non-uterine-specific balloons, such as the
terectomies, various conservative surgical procedures Sengstaken–Blakemore tube, Foley or Rusch catheters,
have been developed to reduce the need for a have also been commonly used for the management

Received: October 7 2017.


Accepted: December 31 2017.
Correspondence: Dr Choi Wah Kong, Department of Obstetrics and Gynaecology, United Christian Hospital, 130 Hip Wo Street,
Kwun Tong, Hong Kong. Email: melizakong@gmail.com

© 2018 Japan Society of Obstetrics and Gynecology 1


C. W. Kong and W. W. K. To

of PPH,6 and in general, a success rate of over 80% packing was not routinely performed unless there
has been reported.7 Due to its simplicity and rela- was evidence of slippage or prolapse of the balloon
tively noninvasive nature, IUBT has been incorpo- through the cervix. If bleeding was arrested after bal-
rated into standard protocols for the management of loon inflation, the balloon tamponade was continued
severe PPH as a second-line conservative surgical pro- for around 24 h, after which the deflation was per-
cedure.3,8 Recent data have shown that the increasing formed in a single stage before removal.7
use of a balloon tamponade was associated with a With increasing utilization of this device in the
reduction in the need for more invasive procedures, department, a protocol for measuring ILP after the
such as radiological uterine artery embolization or achievement of a positive tamponade test was also
compression sutures,9,10 as well as the incidence of instituted since 2015. The purpose of this protocol
peripartum hysterectomy.11,12 was to ensure that the ILP would not grossly exceed
Despite the increasing utilization of IUBT, protocols the systemic blood pressure of the patient as there
for the appropriate use of intrauterine balloon devices were concerns in the literature that excessive pressure
remain empirical,13 and data on the precise mecha- generated by the balloon could lead to complications
nisms and pressure required were scanty in the litera- such as subsequent uterine rupture15,16 or ischemic
ture. The present study aimed to review the necrosis, particularly when IUBT was coupled with
intraluminal pressure (ILP) generated by the Bakri the concurrent application of compression sutures.17
intrauterine balloon that is necessary to produce a In addition, we believe that the collection of such
‘positive tamponade test’14 during the management of data would be useful to evaluate any correlation
severe PPH. We believe that such data should facili- between the infusion volumes used and the actual
tate our understanding of the mechanisms of action ILPs generated. After a positive tamponade test was
of IUBT. clinically achieved, pressure readings were made in
each case using a Benetech pressure manometer
GM520 (Shenzhen Jumaoyan Science and Technology
Methods Co Ltd., China). The ILP was measured by compar-
ing the difference in pressures between the total bal-
All cases of PPH would be managed according to a loon pressure (as measured via a three-way tap
standard protocol in our Department. When first-line connection to the infusion port of the Bakri catheter)
medical management using uterotonic agents, includ- and the baseline intrauterine pressure (as measured
ing syntocinon, Synometrine and Carboprost, failed via the outflow port of the Bakri catheter). Three
to control bleeding, second-line surgical procedures readings were made sequentially to ensure consistent
such as IUBT, compression sutures or uterine artery readings (Fig. 1). The patient’s blood pressure and
embolization would be applied according to the pref-
erence of the obstetrician in charge. The Bakri intra-
uterine balloon catheter (Cook Medical, Bloomington
[IN], US) was the only available balloon tamponade
device for this purpose in our department. We have
established a protocol for using this intrauterine bal-
loon device for the management of severe PPH in the
Department since 2011. Severe PPH was defined as
an estimated blood loss exceeding 1000 mL. The pro-
cedure for the application of the Bakri balloon was in
accordance with that generally described in the
literature.4–6 The Bakri balloon can be placed trans-
vaginally through the cervix or transabdominally
through the caesarean uterine wound. When the bal-
loon was placed through the uterine wound, it would
be half inflated after placement and then further
inflated after closure of the uterine wound so that
inadvertent puncturing of the balloon during suturing Figure 1 The photo showing how the pressure manom-
of the wound would be promptly noted. Vaginal eter is connected to the Bakri balloon.

2 © 2018 Japan Society of Obstetrics and Gynecology


Intraluminal pressure of uterine balloon

other vital parameters were also recorded simulta- complications, estimated total blood loss, route of
neously. Ultrasound scan was also performed to ver- placement of the balloon, amount of saline infused
ify the position of the balloon and the presence of and the presence of clinical shock or coagulopathy.
forward flow in the uterine arteries using color The study was approved by the Research Ethics Com-
Doppler (Fig. 2). Patients who had additional com- mittee of the Kowloon Central/Kowloon East Cluster
pression sutures or had uterine artery embolization of the Hospital Authority, Hong Kong.
after the Bakri balloon tamponade were excluded as
compression sutures or uterine artery embolization
could affect the ILP of the Bakri balloon. Verbal con- Results
sent was obtained for all conscious patients when
performing the measurements. There were a total of 8362 deliveries during the 24-
The study was conducted over a period of month study period. The frequency of primary PPH
24 months, from October 2015 to September 2017. All with an estimated blood loss equal to or exceeding
the patients with an IUBT inserted and who had a 500 mL was 8.12% (n = 679). The frequency of severe
positive tamponade test without the need of other PPH with an estimated blood loss exceeding 1000 mL
second-line procedures, such as compression sutures was 1.15% (n = 96). Among these patients, medical
or uterine artery embolization, were recruited. The treatment was successful in 62, while direct hysterec-
details of each patient were recorded, including the tomy was performed in 4 for placenta accreta. Com-
mode of delivery, etiology of the PPH, intrapartum pression sutures were performed in four patients after
failed medical treatment, and IUBT was attempted as a
primary procedure in 26 (27.1%) of them. In addition,
among the 26 patients with IUBT, 1 patient required
additional compression sutures, and 2 patients required
uterine artery embolization after Bakri balloon inser-
tion. Three patients did not have ILP measurements as
a positive tamponade test was not achieved, and they
were hemodynamically unstable after Bakri balloon
insertion, so a hysterectomy was immediately per-
formed. Therefore, 20 patients were included for final
analysis. The success rate of the IUBT as the first
second-line procedure to control severe PPH and to
avoid peripartum hysterectomy was 20/26 (76.9%).
Of the 20 cases analyzed, 9 had spontaneous vagi-
nal deliveries, and 11 had caesarean sections. Uterine
atony occurred in 13 cases, while bleeding from the
placenta site occurred in the rest. The total blood loss
ranged from 1000 to 2900 mL. The Bakri balloon was
inserted vaginally in all patients with vaginal deliver-
ies and in six who had caesarean sections when exces-
sive bleeding occurred after closure of the uterine and
abdominal wound. Transabdominal placement was
performed in the other five cases that delivered by
caesarean section, with the balloon inserted before
closure of the uterine wound. Peripartum hysterec-
tomy was required in one patient (case 11, Table 1) in
whom caesarean section was performed for placenta
praevia Type III at 37 weeks. Brisk bleeding from the
placental bed of around 1.2 L was encountered at
Figure 2 Ultrasound pictures showing positive flow in removal of the placenta. A Bakri balloon was inserted
the uterine artery (a) with the Bakri balloon in situ via the uterine wound, and a positive tamponade test
(b, c). was achieved with infusion of 350 mL saline after

© 2018 Japan Society of Obstetrics and Gynecology 3


4
Table 1 The clinical details of the 20 patients included for final analysis
C. W. Kong and W. W. K. To

Case Etiology Mode of delivery/ Total blood Presence Presence of Amount of Mean pressure Concurrent Uterine blood Position
number route of balloon loss (mL) of shock coagulopathy saline infused at positive systemic blood flow on color of balloon in
insertion in balloon tamponade pressure Doppler cavity
(mL) test (mmHg) (mmHg)
1 Uterine atony NSD; vaginal 1200 No No 400 69 106/57 Positive Fundal
2 Placenta praevia CS; Abdominal 1100 No No 300 73 89/52 Positive Lower
3 Uterine atony NSD; Vaginal 2050 Yes No 300 90 95/60 Positive Fundal
4 Uterine atony NSD; Vaginal 1560 Yes No 200 73 103/69 Positive Lower
5 Uterine atony NSD; Vaginal 1450 No No 300 89 101/70 Positive Fundal
6 Placenta praevia CS; Abdominal 1000 No No 400 82 113/65 Positive Fundal
7 Uterine atony CS; Vaginal 1200 No No 300 78 124/73 Positive Lower
8 Placenta praevia CS; Abdominal 2100 No No 400 81 92/55 Positive Fundal
9 Placenta praevia NSD; Vaginal 1050 No No 300 77 131/68 Positive Lower
10 Uterine atony CS; Vaginal 1000 No No 250 85 100/67 Positive Fundal
11 Placenta praevia CS; Abdominal 2400 Yes Yes 400 92 110/72 Positive Fundal
12 Uterine atony NSD; Vaginal 1200 No No 380 85 97/69 Positive Fundal
13 Uterine atony NSD; Vaginal 2000 Yes No 200 83 115/71 Positive Fundal
14 Uterine atony NSD; Vaginal 1500 Yes No 300 87 143/79 Positive Lower
15 Placenta praevia CS; Vaginal 1500 No No 450 86 120/61 Positive Fundal
16 Uterine atony CS; Vaginal 1700 No No 300 82 128/75 Positive Fundal
17 Uterine atony CS; Abdominal 2900 Yes Yes 300 81 104/58 Positive Fundal
18 Uterine atony CS; Vaginal 1500 No No 400 88 108/61 Positive Lower
19 Placenta praevia NSD; Vaginal 1400 Yes Yes 180 67 120/65 Positive Lower
20 Uterine atony CS; Vaginal 1000 No No 240 85 117/55 Positive Lower
Shock is defined as systolic blood pressure < 70 and pulse rate ≥ 120. Coagulopathy is defined as either activated partial thromboplastin time ≥ 40 s or fibrinogen level < 2.0 g/L. CS,
caesarean section; NSD, normal vaginal delivery.

© 2018 Japan Society of Obstetrics and Gynecology


Intraluminal pressure of uterine balloon

closure of the wound. There was minimal drainage test during the management of severe PPH varied
from the Bakri balloon, and the patient remained within a narrow range of around 60–90 mmHg and
hemodynamically stable. Recurrence of PPH with had no direct relationship to the mode of delivery,
brisk bleeding of around 1 L was encountered when the volume of saline infused into the balloon and the
the balloon was deflated and withdrawn in one step position of the balloon in the uterine cavity and
24 h later. Relaparotomy and peripartum total hyster- probably has no direct impact on the clinical
ectomy was performed. The final histopathological success rate.
report of the uterus confirmed placenta accreta. Application of intrauterine pressure to produce an
The net ILP measured in this series of patients ran- internal compression effect to control PPH has proba-
ged from 67 to 92 mmHg, and this pressure was bly evolved from uterine packing. While the earliest
lower than the concurrent systolic pressure in all reports of uterine packing could be dated back to the
cases. Color Doppler confirmed positive forward flow 19th century,18 recent studies comparing uterine pack-
in the uterine vessels in all cases (Fig. 2). There were ing techniques with IUBT have found that they were
no significant differences in the pressures measured equally effective without any increase in infective
irrespective of whether the balloon was considered to morbidity.19,20 In practice, effective uterine packing
be in the fundal region or in the lower segment of the required appropriate training, and the packing proce-
uterine cavity, nor was there a direct relationship dure would likely take longer than the inflation of an
between the volume of saline infused and the net IUBT. While the Bakri catheter was initially designed
pressure (Fig. 3). to be used for low-lying placenta,4 it has been widely
used for PPH arising from uterine atony as well. 21,22
Despite arguments against the ‘paradoxical’ use of
Discussion IUBT in uterine atony to expand rather than contract
the uterus, recent studies have found that the method
Our case series showed that the ILP generated by was equally effective for managing PPH from uterine
the Bakri balloon to establish a positive tamponade atony or placental site bleeding.23

Figure 3 Scatter plot of the volume of saline infused into the Bakri balloon versus the intraluminal pressure generated.

© 2018 Japan Society of Obstetrics and Gynecology 5


C. W. Kong and W. W. K. To

In vitro studies have shown that, in the absence of vacuum-induced uterine tamponade to control PPH.29
any external restrictions, the ILP of the Bakri balloon Apparently, the range of ILPs of 60–90 mmHg that
would reach a peak of 60–80 mmHg at 50 mL insuf- we recorded was already sufficient to exert such a
flation, and the pressure does not vary by more than pressure effect on the sinuses of the placental bed to
10–25 mmHg despite the balloon being incrementally achieve hemostasis.
filled to the maximal volume of 500 mL.14,18 Our The manufacturer of the Bakri balloon has included
in vivo pressure readings were in line with these find- disseminated intravascular coagulopathy as one of the
ings. The net ILPs that we have measured were pre- contraindications for Bakri balloon management. Coa-
cisely within this range, and the amount of saline gulopathy would often begin as massive bleeding
infused did not appear to be correlated to the final occurred and could be regarded as an inevitable sequel
pressure. While it was reported that the relationship of uncontrolled PPH. In this study, 3 of 20 patients
between the ILP and the volume of infusion was successfully managed by IUBT had coagulopathy.
curvilinear,18 such a curve probably existed only for While it would be difficult to distinguish whether coa-
the initial 50–100 mL of infusion, after which the gen- gulopathy was the cause or the result of the uncon-
erated pressure would plateau off as long as there trolled PPH, once such a vicious cycle effects has
was residual contractility within the uterus to coun- begun, the attending obstetrician should be alerted to
teract the increase in cavity volume. In our experi- the high chance of failed management with IUBT.
ence, the final infusion volume appeared to be related The value of this study is that we specifically pro-
more to the contractility and capacity of the uterus. spectively measured ILP in patients with severe PPH
However, using the Glenveigh OTS-Ebb tamponade in whom a positive balloon tamponade was
system in normal post-partum patients without PPH achieved. Very scanty data of ILP measurements
has been found that an exponential curvilinear rela- were available in the literature, and the only pro-
tionship between ILP and infusion volume existed, spective case series on the Bakri balloon reported
greater than 1000 mL.24 The difference in the design only two cases18 that was subsequently expanded to
and the materials of the balloon catheters prevented seven cases in a book chapter by the same author.13
the direct comparison of these findings. Another study described ILP studies in eight women
Proposed mechanisms by which the intrauterine using the OT-ebb balloon in normal post-partum
balloon can generate its tamponade effect include cre- women without PPH.24 We believe that the data
ating an intrauterine pressure that exceeded the sys- from our current series would be most valuable in
temic arterial pressure25 or by direct occlusion of the documenting intrauterine balloon pressure relation-
uterine arteries to arrest bleeding.26 With the Glen- ships in women with severe PPH. The major limita-
veigh OTS-Ebb system, it had been shown that there tion of this study is the small number of cases
was progressive increase in the systolic/diastolic analyzed. As our cohort included patients with PPH
velocity ratio on ultrasound Doppler, and when infu- due to uterine atony as well as placental site bleed-
sion volume reached 1000 mL or more (beyond the ing, as well as both vaginal and caesarean delivery,
recommended maximal inflation volume of 500 mL), we believe the pressure measurements in these cases
reversal of diastolic flow would be seen.23 Our find- should be typical and generalizable. However, we
ings were in contrast to these as the net ILP obtained were unable to measure pressure in any patient in
never exceeded the concurrent systolic blood pres- whom a positive tamponade test could not be suc-
sure, and color Doppler had consistently demon- cessfully achieved as these situations were dire emer-
strated continuous forward flow in the uterine gencies in which other modalities of management
arteries. A more compatible hypothesis could be that, were immediately indicated. While there were pre-
by filling up the uterine cavity, the balloon tampo- liminary data attempting to quantity uterine stiffness
nade controls bleeding with direct pressure over the using acoustic radiation force impulse elastography
sinuses of the uterus.27,28 Thus, as long as the pressure as a surrogate measurement of the contractions of
generated is greater than the pressure within the the uterus before and after IUBT,30 in practice, there
bleeding vessels, further hemorrhage would cease, is as yet no simple direct method to gauge the com-
and if the pressure is applied for long enough, the sta- pliance and contractility of the uterine wall in
sis should allow clot formation, and the involved ves- response to expansion of the cavity by the balloon.
sels should constrict and close down.18 Such We agree that the uterus should not be regarded as
mechanisms were probably similar to the use of a passively atonic,13 and the contractility of the uterus

6 © 2018 Japan Society of Obstetrics and Gynecology


Intraluminal pressure of uterine balloon

and its response to stretching should probably be 11. Chan LL, Lo TK, Lau WL et al. Use of second line therapies
the key physiological factor that determines whether for management of severe primary postpartum haemor-
rhage. Int J Obstet Gynecol 2013; 122: 238–243.
the PPH could be controlled by IUBT.
12. Kong CW, To WWK. Trends in conservative procedures and
Our findings suggested that a positive tamponade peripartum hysterectomy rates in severe postpartum hae-
test is probably achieved by local compression pres- morrhage. J Matern Fetal Neonatal Med 2017; 27: 1–7. https://
sure exerted on the vasculature of placental bed rather doi.org/10.1080/14767058.2017.1357169.
than by generating an ILP exceeding systemic blood 13. Einerson BD, Son M, Schneider P, Fields I, Miller ES. The
association between intrauterine balloon tamponade dura-
pressure or by occlusion of flow to the uterine arteries.
tion and postpartum hemorrhage outcomes. Am J Obstet
We believe that the achievement of a positive tampo- Gynecol 2017; 216: 300.e1–300.e5.
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ity of the uterine myometrium to maintain the a positive ‘tamponade test’ in the management of postpartum
pressure required for hemostasis. The ILP generated hemorrhage. In: Arulkumaran S, Karoshi M, Keith LG,
Lalonde AB, B-Lynch C (eds). A Comprehensive Textbook of
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Postpartum Haemorrhage, 2nd edn. London: The Global Library
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Disclosure
Am J Obstet Gynecol 2013; 208: e6–e7.
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None declared. ciated with intrauterine balloon tamponade placement after
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