JOURNAL READING

INTRAUTERINE BALLOON TAMPONADE FOR MANAGEMENT OF

SEVERE POSTPARTUM HAEMORRHAGE IN A PERINATAL
NETWORK: A PROSPECTIVE COHORT STUDY

Diajukan untuk melengkapi syarat kepaniteraan senior Bagian Obstetri

dan Ginekologi Fakultas Kedokteran Universitas Diponegoro

Disusun oleh :
Alif Luqman Hakim 22010116210043
Bellakusuma N 22010116210023
Sherly Mediana 22010116210128
Risky Maulida Hasanah 22010116210146
Radityo Utomo 22010116210113
Azizatul Yaumul Adha 22010116210006
Aulia Izzati 22010116210082
Stefanie Pramudita Jaya 22010116210091

Pembimbing :
dr. Arufiadi Anityo, MSi.Med, Sp.OG (K)

BAGIAN OBSTETRI DAN GINEKOLOGI

FAKULTAS KEDOKTERAN UNIVERSITAS DIPONEGORO
2018
 LEMBAR CRITICAL APPRAISAL
BERDASARKAN PICO – VIA

Journal title : INTRAUTERINE BALLOON TAMPONADE FOR

MANAGEMENT SEVERE POSTPARTUM HAEMORRHAGE IN A
PERINATAL NETWORK: A PROSPECTIVE COHORT STUDY

Journal type :Scientific Report

P (POPULATION or PATIENT or PROBLEM)

The study conducted from July 2010 to March 2013 in a perinatal network of 10
maternity units with a total of around 19 000 deliveries per year. The study com-
prised 226 subjects with severe post partum hemorrhage treated with IUBT as initial
second line therapy after failed first line management therapy.

I (INTERVENTION or INDICATOR or INDEX TEST or exposure of INTERST)

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, including arterial embolisa-
tion, conservative surgical procedures (including uterine compression sutures or
pelvic vessel ligation), and hysterectomy was performed immediately after
withdrawal of the balloon in the operating room.
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.

C (COMPARISON)
There is no comparison in this study.

O (OUTCOME of interest)
Intrauterine balloon tamponade was attempted in 226 women: 171 after vaginal de-
livery (VD) (75.7%) and 55 during or after caesarean delivery (CD) (24.3%). The
global success rate was 83.2% (188/226) and was significantly higher after VD
(152/171,88.9%) than CD (36/55, 65.5%, P < 0.01).
Caesarean Delivery, estimated blood loss before IUBT and coagulopathy were pre-
dictive of IUBT failure.
Is the results of research VALID ?

The result of this study cannot be said as valid, because there is no randomization
and blinding in sampling so it can not be representative of the intended research
population. This study also lack of control group which probably induces overesti-
mation of the IUBT efficacy. The inclusion criteria for being a research sample are
clearly stated that is women with severe post partum hemorrhage unresponsive to
first line therapy and treted with IUBT. The design in this study is appropriate,
which using prospective cohort study method that follows over time a group of
similar individuals who differ with respect to certain factors under study, to deter-
mine how these factors affect rates of a certain outcome.

Is the results of research IMPORTANT ?

This study provide information that intrauterine balloon tamponade is an effective

method for treating severe PPH. 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.

Critical appraisal conclusion

- Level of evidence : IV
- Recommendation :
 Randomization should be done at the sampling in order to repre-
sent the desired target population.
 Further research about success rate in more than one center

Mengetahui
Penilai,

dr. Arufiadi Anityo, MSi.Med, Sp.OG (K)