Journal ReadingCritical Appraisal

Disusun oleh:
Hanifah Rahmania
Perseptor:
dr. H. Wahdi Sdj. Sp.OG
Dr. dr. Anto S. Sp.OG (K) FER
dr. Trestyawaty Sp.OG

SMF OBSTETRI DAN GINEKOLOGI

RUMAH SAKIT UMUM JENDRAL A.
YANI
METRO
2016

Introduction
The most common etiology of neonatal respiratory
distress is transient tachypnea of the newborn; this is
triggered by excessive lung fluid, and symptoms usually
resolve spontaneously. Respiratory distress syndrome
can occur in premature infants as a result of surfactant
deficiency and underdeveloped lung anatomy.
Intervention with oxygenation, ventilation, and
surfactant replacement is often necessary. Prenatal
administration of corticosteroids between 24 and
34 weeks gestation reduces the risk of
respiratory distress syndrome of the newborn
when the risk of preterm delivery is high.

Telaah Kritis Berdasarkan EBM

(P) opulation /problem : Women at 34-36 weeks of
pregnancy at risk of imminent premature delivery.
(I) ntervention : Korticosteroids (Betamethasone
12 mg) i.m for two consecutive days.
(C) omparison : Placebo.
(O) utcomes : Penurunan kejadian morbiditas
respirasi.

Telaah kritis secara umum

Abstract
Introduction
Methods
Results
Discussion
Conclusion

Telaah kritis secara khusus

Validity
Important
Applicability

Validitas Subyek Penelitian

Validitas subyek penelitian:
Dalam jurnal ini peneliti telah menyebutkan kriiteria inklusi dan
eksklusi dengan jelas, serta dijelaskan pula teknik pengambilan
subyek dan perhitungan besar sampel.

Pregnant women receiving care at the institute were included if

they were at 34-36+6 weeks gestation and were at risk of
imminent premature delivery) at the time of admission to
hospital. Gestational age was defined according to the date of the
womans last menstrual period, if known and reliable, or by
ultrasonography before 20 weeks of pregnancy.
Reasons for exclusion from the study included multiple
pregnancy, major congenital malformations, haemorrhagic
syndromes with active bleeding, clinical evidence of
chorioamnionitis, previous use of Corticosteroids.
The sample size was calculated with open source software
(Openepi version 2.3, Atlanta, GA), with an assumed 28.9% rate
of respiratory disorders in late preterminfants, an error of 5%,
and 80%power to detect a reduction of 50% in the rate of
respiratory disorders with the use of corticosteroids.15 This
resulted in a required sample size of 266 (133 in each
group), which we increased to 320 to cater for losses and
exclusions

Validitas Metode
Penelitian

Metode: a randomised, triple blind, placebo controlled

clinical trial between April 2008 and June 2010 at the
Instituto de Medicina Integral ProFernandoFigueira (IMIP),
Recife, a large tertiary teachinghospital in the northeast of
Brazil.
Ketersamaran baik. Peneliti, dokter, dan subyek penelitian
tidak mengetahui kelompok mana yang menerima perlakuan
dan kelompok mana yang menjadi kontrol.
Only the pharmacist responsible for preparing the
boxes was aware of their contents. The investigators,
the physicians who cared for the women, the
statistician, and the women themselves were
unaware of the contents; this information was disclosed
only after data analysis was complete

Validitas Outcome Penelitian

A total of 352 women fulfilled the admission criteria for

the study. Of these, 320 agreed to participate and
were
randomised to receive betamethasone (n=163) or
placebo
(n=157).
43 women were discharged from hospital during pregnancy
and were lost to follow-up (19 and 24, respectively).
Two other exclusions occurred after randomisation in the
placebo group: one because a twin pregnancy was
detected only after randomisation and one because the
pregnancy was found to have already reached term.
Therefore, 144 women remained in the corticosteroid
group and 131 in the placebo group, with 13% of losses
after randomisation
(43 cases). As one stillbirth occurred in each Group,
We analysed 143 babies in the intervention group and
130 in the control group

Metode
1.
2.

3.
4.

5.

Informed consent
Receive the sealed cardboard box corresponding to their
randomisation group. Two ampoules were applied intramuscularly,
with two more being administered 24 hours later.
The study investigators took no part in the prepartum or postpartum
management of the women or in neonatal management
Women in premature labour underwent tocolysis with nifedipine, in
accordance with the hospital routine practice, in an attempt to
postpone delivery and allow the full course of medication to be
administered.
The investigators and the neonatologist who followed up the infants
prospectively collected data on the pregnant women and their
newborns on a standardised form.

Validitas Outcome Penelitian

The primary outcomes were the occurrence
of neonatal respiratory disorders:
respiratory distress syndrome or
transient tachypnoea of the newborn,
defined by the presence of respiratory
distress for more than two
hours after birth and characterised by
tachypnoea, expiratory grunting, chest
wall retractions, flaring of the nostrils,
cyanosis, and a growing need for oxygen

Pertanyaan Validitas Telaah

Kritis
1.
2.
3.
4.
5.

6.

Apakah dilakukan randomisasi dan apakah daftar randomisasi

disegel? Ya
Apakah pemantauan subyek penelitian cukup lama dan lengkap? Ya
Apakah seluruh subyek yang ikut dalam peneltian dihitung dalam
kesimpulan akhir sesuai dengan alokasi awalnya? Ya
Apakah peneliti dan subyek tidak mengetahui siapa yang menerima
perlakuan dan siapa yang menjadi kontrol (ketersamaran)? Ya
Selain perlakuan yang sedang diuji, apakah kedua kelompok
(kelompok perlakuan dan kelompok pembanding) mendapat
perlakuan yang sama? Ya
Apakah kedua kelompok tersebut sebanding pada awal percobaan?
Yang dimaksud sebanding di sini ialah sebanding dalam hal faktorfaktor prognostik yang mempengaruhi hasil keluaran. Ya

Importancy
Analisis Statistik
Epi Info software version 3.5.1
The statistician and the investigators
remained blind to the treatment groups
until the tables had been prepared and
the analysis concluded

Importancy

Applicability Jurnal
Setelah

menyimpulkan bahwa suatu uji

klinis telah valid dan hasilnya cukup
penting, maka pertanyaan selanjutnya
adalah apakah hasil uji klinis ini dapat
diterapkan pada pasien yang kita
hadapi di fasilitas kesehatan tempat kita
bekerja?
Ya, dapat diterapkan pada pasien di
Indonesia

Conclusion
Penelitian ini menunjukkan bahwa pemberian steroid
pada ibu dengan usia kehamilan 34-36 minggu dengan
tujuan sebagai terapi pematangan paru janin tidak
efektif.
Kejadian gangguan pernapasan (respiratory distress
syndrome dan transient takipnea) tidak dipengaruhi
oleh pemberian steroid antenatal setelah kehamilan 34
minggu.
Steroid antenatal yang diberikan setelah usia kehamilan
34 minggu mengurangi risiko neonatal jaundice yang
membutuhkan fototerapi, kemungkin akibat dampak
percepatan pematangan hati pada pemberian steroid

Conclusion
Kehamilan risiko tinggi, dalam penelitian terkini,
menyarankan bahwa ada sedikit kebutuhan untuk
perhatian lebih lanjut mengenai neonatal setelah 34
minggu kehamilan.
Bukti terbaru belum mendukung hal tersebut. Meskipun
memiliki tingkat kematian rendah, bayi prematur akhir
(34-36 minggu) memiliki risiko morbiditas seperti RDS
atau TTN.
Penelitian
ini
menunjukkan
bahwa
pengobatan
antenatal dengan kortikosteroid tidak menyebabkan
penurunan yang signifikan terhadap kejadian morbiditas
gangguan pernapasan neonatal.

TERIMA KASIH

Lung Development

Development of the lung can be divided into two

phases, lung growth (structural development) and
lung maturation (functional development).
Lung growth can be influenced by a host of physical
factors.
Lung maturation and the achievement of functionality is
primarily a biochemical process and is under the control
of a number of different hormones.
Lung growth proceeds through gestation. There is
progressive branching of the airways and finally
development of alveolar spaces capable of gas
exchange in the last trimester.

Lung Development
The surfactant system, composed of phospholipids
that decrease surface tension within the alveoli and
prevent alveolar collapse during exhalation,
develops in the last trimester, and reaches
maturity by approximately 36 weeks.
Lung growth continues after birth as alveolar number
continues to increase. The end result of the
development of the lung is an organ with a
tremendously large surface area that is
approximately 50-100 m2, capable of exchanging
oxygen and carbon dioxide across a very thin
membrane.

Lung Development
Biochemical maturation, that is, production
of surfactant, appears to be independent of
lung growth. What is surfactant and why is it
so important? Surfactant is a mixture of
phospholipids and hydrophobic proteins,
produced by Type II cells, and secreted into
the alveolar space. The principal lipids are
phosphatidylcholine (lecithin) and
phosphatidylglycerol, and the principal
proteins are surfactant proteins B and C

Lung Development
Surfactant

decreases surface tension

within alveoli and prevents collapse of
alveoli during exhalation. In the absence
of surfactant, the alveolus would be
unstable and collapse at the end of each
breath. Tremendous work would be
required to open up the alveolus with
each breath

Lung Development
Type

II cells and their associated

surfactant can develop in the presence
of pulmonary hypoplasia. Gas exchange
is possible by 26-27 weeks, though not
necessarily sustainable. Surfactant
production gradually increases with
advancing gestational age. The
surfactant system matures by 36 weeks
in most fetuses

Lung Development

Production of surfactant by Type II cells is hormonally

influenced. Corticotropin stimulates lung maturation via
cortisol. Cortisol induces fetal lung fibroblasts to produce
fibroblast pneumocyte factor which stimulates surfactant
production in Type II cells. Thyroid hormones are also
required for development of the surfactant system. At the
time of birth, epinephrine and arginine vasopressin
suppress fetal lung liquid formation, and play a role in its
reabsorbtion. These two hormones are in turn dependent on
increasing concentrations of glucocorticoids that occur at
term.
The development of the surfactant system, to the point that
spontaneous respiratory function can occur, usually takes
place by 36 weeks of gestation. Birth before 36 weeks may
be associated with respiratory compromise and failure. The
incidence and severity of the lung disease is greater in
proportion to the degree of prematurity.