The Journal of Maternal-Fetal & Neonatal Medicine

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

Novel combined strategy of obstetric

haemorrhage management during caesarean
section using intrauterine balloon tamponade

Sergey V. Barinov MD, PhD, Yakov G. Zhukovsky MD, PhD, Vladimir T. Dolgikh
MD, PhD & Irina V. Medyannikova MD, PhD

To cite this article: Sergey V. Barinov MD, PhD, Yakov G. Zhukovsky MD, PhD, Vladimir
T. Dolgikh MD, PhD & Irina V. Medyannikova MD, PhD (2015): Novel combined strategy
of obstetric haemorrhage management during caesarean section using intrauterine
balloon tamponade, The Journal of Maternal-Fetal & Neonatal Medicine, DOI:
10.3109/14767058.2015.1126242

To link to this article: http://dx.doi.org/10.3109/14767058.2015.1126242

Accepted author version posted online: 01

Dec 2015.

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 Just Accepted by The Journal of Maternal-Fetal & Neonatal Medicine

Novel combined strategy of obstetric haemorrhage management

during caesarean section using intrauterine balloon tamponade
Sergey V. Barinov, MD, PhD, Yakov G. Zhukovsky, MD, PhD, Vladimir T.
Dolgikh, MD, PhD, Irina V. Medyannikova, MD, PhD
doi: 10.3109/14767058.2015.1126242
Abstract
Objective: The aim of this trial was to evaluate the performance of a
combined strategy of postpartum haemorrhage management, based upon
thromboelastographic (TEG) assessment of coagulation, early surgical
haemostasis and mechanical compression of the uterine wall combined
with uterine cavity draining, via intrauterine balloon tamponade (BT).
Methods: We carried out an open controlled trial, which included 119
women with obstetric haemorrhage (main group – combined strategy:
n=90, control group – conventional strategy: n=29). The combined strategy
included three essential components: (1) early surgical haemostasis, (2)
mechanical pressure upon the uterine wall and draining of the uterine
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cavity via BT, and (3) treatment of blood coagulation disorders identified
via TEG.
Results: The combined haemorrhage management strategy resulted in significantly lower number of
peripartum hysterectomies compared to standard management (4.44% versus 31.03%, respectively, p=0.02).
Blood loss of >2,000 ml occurred significantly less common in the main group compared to the control group
(16.2% versus 27.6%, respectively, p=0.03). Mean total blood loss after combined management was
significantly lower than after the standard approach (2,502±203 ml versus 1,836±108 ml, p=0.04).
Conclusions: The proposed combined strategy of obstetric haemorrhage management represents a powerful
tool for fertility-sparing treatment of this life-threatening condition.

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 Novel combined strategy of obstetric haemorrhage
management during caesarean section using intrauterine
balloon tamponade
Sergey V. Barinov, MD, PhD1*
Yakov G. Zhukovsky, MD, PhD2
Vladimir T. Dolgikh, MD, PhD3
Irina V. Medyannikova, MD, PhD4

1
Omsk State Medical Academy; address: Lenina Street 12, Omsk, Russian Federation, 644043; Tel.:
+7 (3821) 24-06-58; email: barinov_omsk@mail.ru
2
JSC «Gynamed»; address: Staromonetny pereulok 9-1, Moscow, Russian Federation; Tel.: +7 (925)
585-70-37; email: innova21@yandex.ru
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3
Omsk State Medical Academy; address: Lenina Street 12, Omsk, Russian Federation, 644043; Tel.:
+7 (3821) 35-91-93; email: prof_dolgih@mail.ru
4
Omsk State Medical Academy; address: Lenina Street 12, Omsk, Russian Federation, 644043; Tel.:
+7 (908) 809-65-77; email: mediren@gmail.com
*Corresponding author

Short title: Intrauterine balloon for bleeding

Keywords: obstetric haemorrhage, uterine vessel ligation, thromboelastography, haemostatic

external uterine supraplacental assembly suture, intrauterine balloon tamponade.

 Abstract

Objective: The aim of this trial was to evaluate the performance of a combined strategy of

postpartum haemorrhage management, based upon thromboelastographic (TEG) assessment

of coagulation, early surgical haemostasis and mechanical compression of the uterine wall

combined with uterine cavity draining, via intrauterine balloon tamponade (BT).

Methods: We carried out an open controlled trial, which included 119 women with obstetric

haemorrhage (main group – combined strategy: n=90, control group – conventional strategy:

n=29). The combined strategy included three essential components: (1) early surgical

haemostasis, (2) mechanical pressure upon the uterine wall and draining of the uterine cavity
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via BT, and (3) treatment of blood coagulation disorders identified via TEG.

Results: The combined haemorrhage management strategy resulted in significantly lower

number of peripartum hysterectomies compared to standard management (4.44% versus

31.03%, respectively, p=0.02). Blood loss of >2,000 ml occurred significantly less common

in the main group compared to the control group (16.2% versus 27.6%, respectively, p=0.03).

Mean total blood loss after combined management was significantly lower than after the

standard approach (2,502±203 ml versus 1,836±108 ml, p=0.04).

Conclusions: The proposed combined strategy of obstetric haemorrhage management

represents a powerful tool for fertility-sparing treatment of this life-threatening condition.

 Introduction

Obstetric haemorrhage represents a common cause of preventable maternal

morbidity and mortality, and accounts for nearly a third of maternal deaths

globally [1]. Uncontrolled blood loss could lead to emergency peripartum

hysterectomy [2-4], and therefore, the primary aim of obstetric haemorrhage

management is to stop the bleeding at its earliest stages using the least invasive

techniques [5,6].
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Over the last years, a range of fertility-sparing surgical techniques has

been introduced into clinical practice as potent approaches for obstetric

haemorrhage management. These techniques, which form a fertility-preserving

alternative to conventional peripartum hysterectomy, include intrauterine

balloon tamponade [4, 5], uterine devascularisation and compression sutures,

uterine artery embolisation, and ligation of uterine and internal iliac arteries [6,

8, 9].

Blood loss can be exacerbated by pre-existing or acquired

coagulopathies, which develop rapidly as the result of decompensation of the

physiological coagulation mechanisms. In this view, prompt assessment of

blood coagulation profile is integral to successful conservative management of

obstetric bleeding. Tromboelastography (TEG) is a point-of-care laboratory test

which allows to rapidly evaluate the viscoelastic parameters of whole venous

blood in a low shear environment, mimicking the venous blood flow. TEG is

increasingly viewed upon as an important tool for tailoring of haemostatic

 therapy to individual patient’s needs, especially when a decision about costly

blood product transfusion needs to be made [14]. TEG is rapid and easy to

perform, which makes it a strong candidate for assessment of blood coagulation

profile in patients with obstetric haemorrhage.

Collectively, a number of surgical and medical options are currently

available for fertility-sparing treatment of blood loss in obstetrics. However, in

our opinion, combined approaches to obstetric haemorrhage management hold

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particularly great promise. Here, we present the outcomes of a trial which aimed

to evaluate the performance of a combined strategy of postpartum haemorrhage

management, based upon TEG assessment of coagulation [3, 10, 11, 12], early

surgical haemostasis and mechanical compression of the uterine wall combined

with uterine cavity draining, via intrauterine balloon tamponade (BT) [4, 10,

13].
 Methods

Our open controlled clinical trial included 119 women with obstetric

haemorrhage, who met the following inclusion and exclusion criteria. Inclusion

criteria: gestational age between 28 and 42 weeks, labour or post-partum period.

Exclusion criteria were comprised of pregnancy-related (gestational age below

28 weeks, multiple pregnancy, cervical insufficiency, recurrent pregnancy loss,

umblical cord prolapse during labour, chorioamnionitis, injury during labour),

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maternal (congenital abnormalities of the reproductive system, infectious

diseases, tumours, evidence of sub- or decompensation of chronic internal

diseases), and foetal (foetal chromosomal pathology or congenital

malformations, and congenital foetal viral or microbial infection) exclusion

criteria.

Study participants were recruited from a consecutive population and

divided into two groups to evaluate the efficacy of combined strategy of

postpartum management during caeserean section. The main group consisted of

90 women in whom the combined strategy of haemorrhage management was

used. The control group included 29 women, in whom a conventional

management strategy was applied.

The combined strategy of haemorrhage management in the main group

included three essential components: (1) early surgical haemostasis, (2)

mechanical pressure upon the uterine wall and draining of the uterine cavity via
 intrauterine balloon tamponade (BT), and (3) treatment of blood coagulation

disorders identified via thromboelastography (TEG).

The surgical haemostatis was performed in the main group if the blood

loss exceeded 1,000 ml (early surgical haemostatis), given a high risk of

subsequent major obstetric bleeding. This included ligation of the branches of

descending uterine arteries at the posterior wall of the uterus, ligation of

bleeding vessels of the placental site, and positioning of an external uterine

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haemostatic supraplacental assembly suture. External uterine supraplacental

assembly sutures were characterised by a distinctive localisation feature – they

were placed specifically within the zone of the placental site. The suture

involved positioning of a Vicryl (1/0) thread at the depth of one-third of

myometrium thickness and tightening the thread in a transverse direction

similarly to the ‘assembilng’ single-thread technique. This modification of the

external uterine suture allowed surgical haemostasis at the placental site without

decreasing the volume of the uterine cavity.

In participants undergoing caeserean delivery for placenta praevia, the

ligation of descending branches of the uterine arteries was performed prior to

placental separation to promptly identify the sections of placenta accreta. If the

sections of placenta accreta were identified, these were excised and a

simultaneous 8-shaped suture was positioned at the placental site. In these

patients, we also performed the external uterine haemostatic supraplacental

assembly sutures.
 In addition to early surgical haemostatis, intrauterine balloon tamponade

(BT) was also applied in the main group for haemorrhage management. During

BT, a modified obstetric uterine balloon catheter (Zhukovski double-balloon

obstetric catheter) was inserted into the uterine cavity through the uterine

incision and advanced through the cervical canal using a specialised guide

(Figure 1). The balloon was filled with saline to achieve mechanical

compression of the placental site and left in the uterus for 3 to 6 hours, after
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which it was emptied and removed.

For prompt evaluation of individual blood coagulation status in patients

in the main group, TEG was performed. TEG was carried out using a TEG®

5000 device (Haemoscope, USA). For TEG, a sample of venous blood was

stabilised with sodium citrate in a kaolin cuvette. A standard cuvette was placed

into a cup, and 20µl of 0.2M calcium chloride solution along with 340 µl of

kaolin-activated blood was transferred to the cuvette. The sensor rod was then

immersed into the blood. The cup was slowly shaken at 37°C, and blood clot

formation in the cuvette was observed. Once the clot has formed, the sensor rod

began rotating together with the clot. Coagulation profile was assessed using

five basic TEG parameters: (1) R − time from the start of the test until the point

when signal amplitude reached 2 mm; (2) K − time required for the signal

amplitude to increase from 2 to 20 mm, which reflected the formation of blood

clot; (3) α-angle − speed of fibrin clot density increase; (4) MA − maximum

amplitude; (5) LI30 − percentage of 30-minute clot lysis.

 Conventional management of haemorrhage consisted of the uterine

massage, manual examination of the uterus, transfusion of freshly-frozen

plasma (FFP), red blood cell (RBC) mass, platelet concentrate and protease

inhibitors, as well as surgical haemostasis, as described above. In these patients,

surgical haemostatis was performed at the conventional time point when the

blood loss volume exceeded 2,000 ml. In the cases of severe obstetric bleeding,

autologous red blood cell reinfusion was carried out using a Cell Saver device
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(Haemonetics, USA).

Standard blood coagulation assessment was performed in the

haemostasis laboratory of the District Hospital and included the following tests:

platelet count, activated partial thromboplastin time, thrombin time,

prothrombin index, fibrinogen concentration, levels of soluble fibrin-

monomeric complexes, and lupus anticoagulant.

The rate of peripartum hysterectomies was used as a primary outcome.

Secondary outcomes included: total blood loss volume, rate of blood loss

>2,000 ml, and total volumes of infusion therapy, FFP, RBC and platelet

concentrate used.

Statistical analysis was carried out using SPSS v.17.0 and STATISTICA

v.6.0. Normally distributed continuous variables are presented as mean ±

standard deviation (SD). Continuous variables, which were not normally

distributed, are presented as median and 25% and 75% percentiles [median

(25%; 75%)]. Continuous and ordinal variables were analysed using

 nonparametric statistics: Kruskall-Wallace test, Mann-Whitney U-test,

Wilkoxon W-test. Categorical variables were analysed using the Pearson Chi-

Square test, accounting for the degrees of freedom (df). Predictive power of

blood coagulation parameters was calculated from the measurements of area

(AUC) under receiver-operator curve (ROC) with two-tailed 95% confidence

interval (CI), accounting for the standard error (SE). Differences were

considered significant at p<0.05. The trial was carried out under ethical
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approval by the Omsk State Medical Academy Ethics committee (approval

reference #104, issued on 14 November 2013).

 Results

In 2012-2014, our hospital performed 9,721 deliveries, among which 4,259

(46.5%) were caesarean sections. Our trial included 119 women with

postpartum haemorrhage. The mean age of participants was 28.5±5.4 years. The

majority of participants (65.4%) were resident in rural areas and had previous

history of pregnancies/deliveries. The proportion of primigravidae reached

19.5%, and primiparous – 37.1%. Gestational age and past medical history,
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including obstetrics medical history, were not significantly different between

the two groups.

Among the indications for caesarean section, the leading conditions were

placenta praevia and multiple pregnancy, observed approximately in one in

three and one in five participants, respectively. Other indications included

placental abruption, uterine scar defects, concomitant somatic conditions, severe

pre-eclampsia and pregnancy after IVF (Table 1). The indications for caesarean

section were not significantly different between the two groups.

The majority of obstetric haemorrhages (92 cases; 77.3%) originated

from the lower uterine segment and were associated with placental

abnormalities such as placenta praevia, placental abruption or placenta accreta,

uterine scar defects or multiple pregnancy. The remaining 27 (22.7%) cases of

haemorrhage were caused by uterine atony (concomitant non-obstetric

pathology, pregnancy after IVF, severe pre-eclampsia).

 Analysis of the primary and secondary outcomes of the trial demonstrated

that overall haemostatic effect was more pronounced in the main group. Most

importantly, the combined haemorrhage management strategy resulted in

significantly lower number of peripartum hysterectomies, compared with the

standard management (4.44% versus 31.03%, respectively, p = 0.02).

Furthermore, blood loss of >2,000 ml occurred significantly less common in the

main group compared to the control group (16.2% versus 27.6%, respectively, p
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= 0.03), and the mean total blood loss after combined management was

significantly lower than after the standard approach (2,502 ± 203 ml versus

1,836 ± 108 ml, p = 0.04).

In the control group, ligation of uterine blood vessels was performed

only in 10 (34.48%) women. It is worth emphasising that in the main group

surgical techniques were used at earlier stages. As such, 39 (43.3%) cases of

uterine vessel ligation in the main group were performed prior to placental

separation. In contrast, ligation of uterine vessels in the control group was

carried out only upon the diagnosis of major obstetric haemorrhage. Autologous

red blood cell reinfusion was carried out using a Cell Saver device in every

fourth patient (22.5%) (Figure 2).

Assessment of TEG parameters of blood clotting allowed to promptly

evaluate the extent of individual adaptation to blood loss, and tailor medical

therapy to the patient’s needs. According to TEG, patients with obstetric

haemorrhage primarily experienced an impairment of platelet function and

 coagulation mechanisms (MA 40 [30; 40] mm, p = 0.001, Angle 45 [40; 50]°, p

= 0.03). The highest ability for prediction of major obstetric haemorrhage was

observed for fibrin clot density MA [AUC = 0.9 (95% CI 0.83 -0.95), p<0.001]

(Figure 3).

Transfusion of blood coagulation factors (Protromblex 600, Coagyl),

FFP, cryoprecipitate and platelet concentrate was carried out simultaneously

with the surgical haemostasis. The choice of specific products was driven by the
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TEG results.

The range and volume of products used for the treatment of hypervolemia

and coagulation disorders was significantly different between the two groups

(Table 2). In the control group, a significantly higher total volume of infusion

therapy and FFP was required compared to the main group (infusion: 4,441 ±

907 ml versus 2,437 ± 730 ml, p = 0.041; FFP: 2,498 ± 503 ml versus 1,196 ±

415 ml, p = 0.034, respectively). A significantly quicker recovery of blood and

coagulation parameters was observed during the early post-partum period in the

main group. The blood loss of ≥ 2,000 ml was observed in 16.2% of women in

the main group and 27.6% of women in the control group (р=0.03). The total

blood loss volume in the main group was significantly less than in the control

group (2,502 ± 203 ml versus 1,836 ± 108 ml).

Collectively, the most prominent haemostatic effect in this trial was

observed in the main group. Most importantly, the standard management

 resulted in a significantly larger number of hysterectomies (31.0% versus 4.4%,

р=0.02).

It is worth mentioning, however, that the combined strategy was not

effective in all cases. In this trial, 6 women experienced haemorrhage after 3-6

hours from the removal of the intrauterine balloon, justifying re-laparotomy. In

2 of these cases caused by secondary uterine atonia, final haemostasis was been

achieved by the positioning of additional compression sutures and re-insertion

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of the balloon. In the remaining 4 cases, hysterectomy had to be performed due

to persisting coagulopathy. However, this extensive surgical intervention was

performed with the intrauterine balloon still in place, which allowed to reduce

the total blood loss and save the life of the patient.
 Discussion

Obstetric haemorrhage remains a common cause of preventable maternal deaths

and severe maternal morbidity globally [1], and in many cases is associated

with ante- or intranatal risk factors [1,2]. In our study, more than two thirds of

peri-partum haemorrhages during caserean section originated from the lower

uterine segment and were associated with ‘classic’ obstetric conditions such as

placenta praevia, post-casaerean scar defects and multiple pregnancy. These

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conditions can be promptly diagnosed and accounted for during antenatal

management, thereby decreasing the risk of unexpected obstetric bleeding and

minimising the deleterious outcomes. However, in the remaining cases in our

trial, bleeding was caused by uterine atony in presence of concomitant non-

obstetric conditions, severe pre-eclampsia, or pregnancy after IVF, which

further supports the well-established clinical experience that bleeding can

develop in the absence of conventional risk factors.

Obstetric bleeding can have detrimental outcomes upon natural fertility

if conservative techniques of bleeding managment fail and hysterectomy needs

to be performed. Development of the strategies for conservative treatment of

haemorrhage is among the central research directions in modern obstetrics. In

contrast to radical treatment, these strategies allow to preserve the ability for

natural conception and pregnancy later in life. Radical surgery for obstetric

haemorrhage in women of reproductive age represents a life-changing

intervention, and can cause substantial psychological impact upon personal and
 social relationships. In addition, hysterectomy has been shown to result in long-

term effects, spanning far beyond the loss of natural fertility. These effects

include impairment of the pelvic floor functioning, and are caused by the

changes in blood supply, lymphatic drainage and nerve function. Collectively,

these anatomical and functional changes can lead to pelvic organ prolapse,

urinary incontinence and sexual dysfunction, ultimately decreasing the woman’s

quality of life [2, 7]. In this view, there is a strong need for development of
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fertility-sparing bleeding management approaches.

In our study, we evaluated performance of the combination of early

surgical haemostasis and mechanical compression of the uterine wall coupled

with uterine cavity draining, via intrauterine balloon tamponade. We

complemented this management strategy with an assessment of blood

coagulation profile using TEG, a straightforward point-of-care test [6,7,14]. In

our study, the proposed management of postpartum haemorrhage during

caesarean section significantly reduced the number of peripartum

hysterectomies, blood loss volume, and the use of freshly frozen plasma

compared to control group. Specifically, the rate of peripartum hysterectomies

was reduced by almost 8-fold, blood loss – by 1.5-fold, and freshly frozen

plasma transfusion – by 2.0-fold. Therefore, we believe that the proposed

combined strategy of obstetrics haemorrhage management represents a powerful

tool for fertility-sparing treatment of this life-threatening condition.

 Declaration of Interests

The authors report no conflict of interests.

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 Table 1.
Indications for caesarean section in women with obstetric haemorrhage
Indication Main group Control group Total
(n=90) (n=29)
Placenta praevia 29 (32.2%) 8 (27.6%) 37 (31.1%)
Multiple pregnancy 20 (22.2%) 6 (20.7%) 26 (21.9%)
Concomitant conditions 9 (10.0%) 4 (13.8%) 13 (10.9%)
Placental abruption 11 (12.2%) 5 (13.8%) 15 (12.6%)
Uterine scar defects 10 (11.1%) 6 (13.8%) 14 (11.8%)
Severe pre-eclampsia 7 (7.8%) 2 (6.9%) 9 (7.6%)
Pregnancy after IVF 4 (4.4%) 1 (3.5%) 5 (4.2%)

Table 2.
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Total volume of transfusion therapy in patients undergoing combined and

conventional management of the lower uterine segment bleeding
Main group Control group
Parameter P
(n=90) (n = 29)
Total transfusion volume, ml 2437.2 ± 730.1 4440.8 ± 907.0 0.041
Freshly frozen plasma, ml 1196.1 ± 414.9 2497.6 ± 502.7 0.034
Red blood cell mass, ml 1203.2 ± 313.7 1525.4 ± 570.1 0.063
Platelet concentrate, doses 1.14 ± 0.60 0.95 ± 0.72 0.057
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