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Barinov2015 Non RCT Intervention Ga Sesuai
Barinov2015 Non RCT Intervention Ga Sesuai
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
Article views: 14
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.
© 2015 Taylor & Francis. This provisional PDF corresponds to the article as it appeared upon
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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
Objective: The aim of this trial was to evaluate the performance of a combined strategy of
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.
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
morbidity and mortality, and accounts for nearly a third of maternal deaths
management is to stop the bleeding at its earliest stages using the least invasive
techniques [5,6].
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uterine artery embolisation, and ligation of uterine and internal iliac arteries [6,
8, 9].
blood in a low shear environment, mimicking the venous blood flow. TEG is
blood product transfusion needs to be made [14]. TEG is rapid and easy to
particularly great promise. Here, we present the outcomes of a trial which aimed
management, based upon TEG assessment of coagulation [3, 10, 11, 12], early
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.
mechanical pressure upon the uterine wall and draining of the uterine cavity via
intrauterine balloon tamponade (BT), and (3) treatment of blood coagulation
The surgical haemostatis was performed in the main group if the blood
were placed specifically within the zone of the placental site. The suture
external uterine suture allowed surgical haemostasis at the placental site without
assembly sutures.
In addition to early surgical haemostatis, intrauterine balloon tamponade
(BT) was also applied in the main group for haemorrhage management. During
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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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
clot; (3) α-angle − speed of fibrin clot density increase; (4) MA − maximum
plasma (FFP), red blood cell (RBC) mass, platelet concentrate and protease
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).
haemostasis laboratory of the District Hospital and included the following tests:
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
distributed, are presented as median and 25% and 75% percentiles [median
Wilkoxon W-test. Categorical variables were analysed using the Pearson Chi-
Square test, accounting for the degrees of freedom (df). Predictive power of
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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(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
19.5%, and primiparous – 37.1%. Gestational age and past medical history,
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Among the indications for caesarean section, the leading conditions were
pre-eclampsia and pregnancy after IVF (Table 1). The indications for caesarean
from the lower uterine segment and were associated with placental
that overall haemostatic effect was more pronounced in the main group. Most
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
uterine vessel ligation in the main group were performed prior to placental
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
evaluate the extent of individual adaptation to blood loss, and tailor medical
= 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).
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 ±
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
р=0.02).
effective in all cases. In this trial, 6 women experienced haemorrhage after 3-6
2 of these cases caused by secondary uterine atonia, final haemostasis was been
performed with the intrauterine balloon still in place, which allowed to reduce
the total blood loss and save the life of the patient.
Discussion
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
uterine segment and were associated with ‘classic’ obstetric conditions such as
contrast to radical treatment, these strategies allow to preserve the ability for
natural conception and pregnancy later in life. Radical surgery for obstetric
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
these anatomical and functional changes can lead to pelvic organ prolapse,
quality of life [2, 7]. In this view, there is a strong need for development of
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hysterectomies, blood loss volume, and the use of freshly frozen plasma
was reduced by almost 8-fold, blood loss – by 1.5-fold, and freshly frozen
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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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