JOURNAL READING

Intrauterine balloon tamponade for management of severe

postpartum haemorrhage in a perinatal network: a prospective cohort
study

M Revert,a J Cottenet,b,c P Raynal,d E Cibot,e C Quantin,b,c,f,g,h

P Rozenberga,e

Disusun Oleh:

D O K T ER P E N G UJI : 1. Alif Luqman Hakim 5. Risky Maulidah Hasanah

2. Radhityo Utomo 6. Azizatul Yaumul Adha
D R . A R U FI A DI A N I TYO MO C H TA R , S P.O G ( K )
3. Bellakusuma N. 7. Aulia Izzati
4. Sherly Mediana 8. Stefanni Pramudita
Introduction
 Severe postpartum
PPH is among the most
haemorrhage (PPH)
common causes of in the
affects 1–2% of
USA and Europe and
deliveries in high-
remains the leading
income countries and
cause of maternal death
its frequency is
in France.
increasing.
Postpartum hysterectomy is the most common and final
procedure for achieving arrest of severe PPH.

Alternative procedures, such as uterine compression sutures,

pelvic vessel ligation and arterial embolisation, can be attempted
to avoid hysterectomy.

More recently, intrauterine balloon tamponade (IUBT) has

emerged as a widely recommended technique for avoiding
invasive proce- dures
Methods
In 2008, IUBT became standard practice in tertiary
university referral hospital as initial second-line
for sever PPH unresponsive to prostaglandins.
Evaluated after 2 years.

July 2010 until March 2013, prospective cohort study

about was conducted to evaluate the effectiveness of
IUBT for management of severe PPH and identify the
factors predicting IUBT failure in a perinatal network
of 10 maternity units with a total of around 19 000
deliveries per year.
• Subjects: All women with severe PPH treated with IUBT as initial second line
after failed first-line management therapy.

• The tamponade test was considered successful if there was no bleeding through either the
cervix or the balloon drainage channel 15 minutes after placed in the uterus and inflated with
400–500 ml of sterile water. After 12 hours, it was deflated to half its volume of water and was
completely removed 12 hours later.

• The tamponade test was considered a failure, if bleeding continued and

an emergency radiological or surgical invasive procedure was performed
immediately after withdrawal of the balloon in the operating room.
For each case of PPH treated by IUBT,
maternal and obstetrical data were
collected, including the times of the
different procedures/examinations,
from the medical charts.
The failure of IUBT was defined as the
need for any invasive procedure,
including arterial embolisation,
conservative surgical procedures
(including uterine compression
sutures or pelvic vessel ligation), and
hysterectomy.
Severe PPH was defined by its
unresponsiveness to first-line treatment.
The primary outcome measure was the
global success rate of IUBT, expressed as
the number of women with severe PPH
treated successfully, divided by the total
number treated by IUBT.
Other outcomes were IUBT success rates
after vaginal and caesarean deliveries and
factors associated with IUBT failure.
 Pearson chi-square Factors identified as These models were
or Fisher exact tests associated with IUBT constructed by
were used to failure with a P- backward stepwise
compare categorical value <0.20 in these regression, to
variables between univariate analysis estimate the
the groups with were included in relations between
successful and failed multivariate logistic the baseline
IUBT, and Student or models. characteristics and
Mann–Whitney the relevant clinical
tests to compare the variable for the risk
continuous of IUBT failure.
variables.

All hypotheses were tested at the two-tailed 0.05 significance level.

Hosmer–Lemeshow test, a statistical test for goodness of fit, were performed to
verify the validity of our model.
SAS software 9.3 (SAS Institute, Cary, NC, USA)
was used for the statistical analyses.
Result
The global
success rate
was 83.2%
General
IUBT and obstetric
success rate :characteristics of the study population

84.7% (155/183)  uterine atony

75.8% (25/33)  placenta praevia
(p = 0.70).
`
 IUBT success rate : IUBT success rate:
reference hospital vs other maternity units Bakri vs ebb
80.7% (71/88) vs 83.3% (165/198) vs
84.7% (117/138), 82.1% (23/28)
P = 0.53] P = 0.79.

Insertion failed for seven In three, bleeding nonetheless The remaining four
women (all with Bakri stopped without any underwent embolisation
balloons). additional procedures. and/or conservative surgical
procedures.

No women died in this cohort No other adverse outcome was

study. observed to be associated with either
One woman developed IUBT or a delay of an invasive
endometritis. procedure associated with IUBT use.
The small number of IUBT failures (n = 38) required us to
limit the multivariable model to three variables:
Maternal age IUBT failure
mode of delivery
Predictive of IUBT failure
estimated blood loss before IUBT
Estimated blood loss before IUBT replaced by coagulopathy.
The odds ratio for coagulopathy as a risk factor for IUBT
failure was 5.6 (2.5–13.0).
Discussion
Main
Findings

IUBT failure:
mode of Failure of IUBT:
IUBT effective delivery, Bleeding not
for management estimated blodd substantially
of severe PPH loss before IUBT, responsive to
and IUBT within 15”
coagulopathy
Strenghts Limitations

Large number of patient Lack of control group

Some data about estimated blood loss

Most cases involved severe PPH
before IUBT were missing

All maternity units in the network Did not collect any data about difficulty in
followed a common protocol removing the placenta

19/ 51 patients had undergone

operative or embolisation procedures
Interpretation
Results are consistent with the results of two reviews of
much smaller studies,  a success rate 84–91.5%.
IUBT was added as the initial second-line therapy to the
protocol for management of severe PPH due to uterine
atony unresponsive to sulprostone.
The global IUBT success rate in that study of 31 women with
vaginal deliveries and 12 with caesareans was 86% (37/43).
 Important and modifiable factor associated with
IUBT failure:
severity of blood loss before IUBT  risk of
coagulopathy ↑ early IUBT
15 minutes after bleeding
elapsed time between PPH diagnosis and balloon
insertion not associated  slow hemorrhages
persists (ncomplete response to uterotonic drug)
Interpretation
women receiving IUBT at lower
estimated blood loss quartiles 
higher nadir haemoglobin,
fewer transfusions of PRC,
fewer ICU admissions
fewer hysterectomies
 Late 1st w/ prosta-
Early 
line glandin

MORE EFFECTIVE
In preventing

need for blood

transfusions
IUBT in Trial about earlier
PPH embolisation use of IUBT  no
ballons were used
Management conservative prophyllactically
surgical procedure
risks
and cost
 efficacy of IUBT can be assessed rapidly and readily

avoiding a potential increase in maternal morbidity due to a delay in

more invasive PPH management

Advantages Fails  decreases bleeding while awaiting embolisation or surgery

of IUBT
Success rate ↑ for two main causes of PPH : Atony uteri and plasenta
praevia

using IUBT with or without B-Lynch sutures in 20 women with severe postpartum
haemorrhage 12 only balloon 6 balloon & B-Lynch suture.
Interpretation
Misuse of IUBT in two cases of undiagnosed uterine rupture in women without
any history of caesarean delivery delayed appropriate emergency surgery
The need for careful exploration of the genital tract under anaesthesia for
traumatic damage before any IUBT attempt.
Severe PPH preceded the IUBT in both women.
IUBT used Bakri balloon
◦ Post market data: bleeding decreased or stopped in 50/51 of the women
(98%) after balloon placement
◦ nearly one-half (23/51) of those women required uterine balloon volumes of
>500 ml to control bleeding.
Conclusion
 IUBT sed before any
IUBT should be a
invasive procedure in PPH
systematic part of the
due to atony or placenta
management protocol for
praevia unresponsive to
PPH.
medical therapy.

It unknown whether it should Or as the last first-line

be implemented as the initial therapy, together with
second-line therapy when prostaglandin administration,
prostaglandin administration transforming the vertical
has failed algorithm to a horizontal flow.
 The objective of our
study was to evaluate
the effective- ness of this
non-invasive technique A second objective was to
in a large prospective identify the factors predicting
cohort study set in a IUBT failure.
perinatal network
including different levels
of care.
CRITICAL
APPRAISAL
ACCORDING PICO - VIA
P (POPULATION or PATIENT or PROBLEM)

July 2010 – March 2013

In a 10 maternity units  19.000

deliveries per year

Comprised 226 subjects with sever

PPH

Treated with IUBT as initial second

line therapy after failed first line
management therapy
I (INTERVENTION or INDICATOR or INDEX TEST
or exposure of INTEREST)
• Successful : no bleeding through cervix/balloon drainage channel 15 minutes after placed in the
uterus and inflated with 400–500 ml of sterile water  12 hours  deflated to half  completely
removed 12 hours later.
Tamponade
Test • Failure : bleeding  needs invasive procedure immediately after withdrawal of the balloon

• Severe PPH was defined by its unresponsiveness to first-line treatment.

• global success rate of IUBT

• IUBT success rates after vaginal and caesarean deliveries
Primary
• factors associated with IUBT failure
Outcome
C (COMPARISON)

 Global success rate between IUBT which was attempted in women

after vaginal delivery (VD) and caesarean delivery (CD)
O (OUTCOME of interest)

The global success rate

Caesarean Delivery,
was 83.2% (188/226) and
estimated blood loss
was significantly higher
before IUBT and
after VD (152/171,88.9%)
coagulopathy were
than CD (36/55, 65.5%, P
predictive of IUBT failure.
< 0.01).
Is the results of research VALID ?
The
design in
The
this study
inclusion
no is
criteria
randomi- appropri-
for being
cannot zation lack of ate,
a
be said and control which
research
as valid blinding group using
sample
in prospect
are
sampling -ive
clearly
cohort
stated
study
method
Is the results This study provide
information that
intrauterine balloon
of research tamponade is an effective
method for treating severe
PPH.
IMPORTANT ? Early balloon deployment
before the development of
coagulopathy increases its
success rate.

Caesarean delivery, high

estimated blood loss
before IUBT, and
coagulopathy were
predictive of IUBT failure.

Statistical analysis of this

study correlates variables
so that p-value and odds
ratio were obtained.
Is the results of research
APPLICABLE ?

This study can be applied to the population and in

Indonesia but requires further research.
Conclusion

Level of evidence : IV

Recommendation :

Randomization should be done at the sampling in

order to represent the desired target population.

Further research about success rate in more than

one center
THANK YOU