Langkah 1

: Pertanyaan apa yang akan anda jawab?

PICO saya

Populasi

: Wanita dewasa

Intervensi

: Misoprostol

Comparison

: Kuretase

Outcome

: Abortus spontan

Apakah misoprostol lebih efektif untuk terapi abortus spontan dibandingkan

kuretase pada wanita dewasa?
PICO jurnal

Populasi

: Wanita dewasa

Intervensi

: Sublingual misoprostol

Comparison

: Tindakan operatif

Outcome

: Abortus inkomplet

Langkah 2

: Sebaik apakah penelitian ini dikerjakan? (Validitas

Internal)
1. Rekrutmen

: Apakah subyek mewakili?

Apa yang terbaik?

Ya
Komentar

: kriteria kelompok pasien sudah ditentukan. Penelitian ini

dilakukan antara bulan Mei 2007 sampai Oktober 2010.
Total populasi pada penelitian ini adalah 860 wanita yang
dibedakan menjadi 2 grup, yaitu 480 wanita pada kelompok
misoprostol dan 380 wanita pada kelompok tindakan
operatif.

Lokasi

penelitian

di

Gudiawaye,

Senegal;Nouakchott, Mauritania; Niamey, Niger; Ibadan,

Nigeria;dan Ouagadougou dan Bobo Dioulasso, Burkina

Faso. Semua wanita yang tinggal dan bekerja sampai 1 jam

jarak tempuh yang telah terdiagnosis abortus inkomplet di
dalam riwayat hidupnya yang lalu dan saat sekarang dengan
diagnosa USG atau ostium uteri yang telah membuka.
Kriteria inklusinya adalah kontraindikasi dengan
obat pada penelitian ini, ukuran uterus yang lebih besar dari
12 minggu, tidak ada tanda infeksi, tidak ada gangguan
hemodinamik, kesehtan secara umum baik, dan kesediaan
untuk menyediakan kontak informasi yang bisa dihubungi
untuk tindakan follow up.
Kriteria eksklusi dari penelitian ini adalah wanita
yang suspek atau telah terdiagnosis kehamilan ektopik.

Methods: A total of 860 women received either sublingual misoprostol or

standard surgical care for treatment of incomplete abortion in a multi-site
randomized trial. Women with confirmed incomplete abortion, defined as past or
present history of vaginal bleeding during pregnancy and an open cervical os,
were eligible to participate. Participants returned for follow-up one week later to
confirm clinical status. If abortion was incomplete at that time, women were
offered an additional follow-up visit or immediate surgical evacuation.
(Abstrak, methods)
Data from one multi-site (Mauritania, Niger and Senegal) and two
country-level (Burkina Faso and Nigeria) randomized trials comparing
sublingual misoprostol to standard surgical care for treatment of incomplete
abortion were combined. All women presenting to one of the study sites (located
in Gudiawaye, Senegal;Nouakchott, Mauritania; Niamey, Niger; Ibadan,
Nigeria; and Ouagadougou and Bobo Dioulasso, Burkina Faso), who lived or
worked within 1 hour travel time, who had a confirmed incomplete abortion
(spontaneous or induced), and who met the study criteria were invited to
participate. An eligible incomplete abortion was defined as past or present history

of vaginal bleeding during pregnancy and an open cervical os (if ultrasound not
used) or evidence of incomplete abortion with substantial debris in uterus, if
ultrasound used. Requirements for eligibility included no contraindications to the
study drug, uterine size no larger than that consistent with 12 week gestation at
time of presentation for care, no signs of severe infection, no hemodynamic
disturbances,general good health, and willingness to provide contact information
for purposes of follow-up. Women whowere suspected of having an ectopic
pregnancy were not eligible for the study.
(Paragraf 4, halaman 2, methods)

Result :A total of 860 women were enrolled in the study between May 2007 and
October 2010 (Figure 1). Participants were randomly assigned to 1 of the 2 study
groups: 480 to misoprostol and 380 to standard surgical treatment.
(Result paragraf 1 halam 3)
2. Alokasi

: Apakah penempatan acak dan disembunyikan?

Apa yang terbaik?

Tidak
Komentar

: Penempatan dan perlakuan responden sesuai dengan

praktek standar masing-masing rumahsakit. Pengacakan
dilakukan pada sisi multicenter diacak bersama, sedangkan
pada sisi 2 tingkat negara di acak secara individual. Namun
tidak dijelaskan bagaimana cara pengacakannya.

Participants were randomly assigned to either onedose of 400 mcg of

sublingual misoprostol (200 mcg tablet

2) (CytotecW, Pfizer, USA) or a

surgical evacuation of the uterus following standard practice at each hospital

(MVA or D&C). (The multicenter sites were randomized together and the two
country-level sites were randomized individually).
(Paragraf 6 halaman 2)

a. Sehingga kelompok sebanding pada awal percobaan?

Ya
Komentar : Semua kelompok terlihat sebanding, berdasarkan kriteria
masing-masing. P value untuk setiap kriteria menunjukan
tidak ada perbedaan dari masing-masing kriteria.

(Halaman 4)

3. Maintanance : Apakah kelompok-kelompok memperoleh ko intervensi

yang sama?
Apa yang terbaik?
Ya
Komentar

: Sekali subjek ditempatkan ke kelompok, maka semua

subjek diatur secara sama, outcome yang revelan diukur
menggunakan

metodologi

kelompok tersebut.
kelompok

yang

Wanita

misoprostol

sama

untuk

kedua

yang ditempatkan pada

meminum

pil

yang

telah

diintruksikan dari rumahsakit, untuk menahan pil dibawah

lidah mereka selama 30 menit dan menelan beberapa sisa

dari pecahan obatnya. Wanita yang ditempatkan pada

kelompok tindakan operatif/bedah dengan cepat di evakuasi
ke ruang operasi di rumahsakit tersebut. Pada kelompok
operatif ini diberi analgesik dan antibiotik dan tidak di
anastesi/dibius. Kemudian semua pasien diminta kembali
setelah 1 minggu pengobatan untuk mengkonfirmasi status,
untuk melihat apakah ada perdarahan, uterus yang
membesar atau kehamilan ektopik yang didiagnosis
menggunakan USG. Pada kasus ini responden diberi pilihan
untuk secepatnya dioperasi atau tunggu satu minggu lagi
untuk di follow up kembali memungkinkan untuk
terjadinya pengeluaran secara spontan. Jika follow up yang
kedua belum terjadi pengeluaran secara spontan, kemudian
langkah selanjutnya harus dioperasi.

Women assigned to the misoprostol group took the pills at the hospital and
were instructed to hold the pills under their tongues for 30 minutes and then
swallow any remaining tablet fragments. They were then discharged at the
providers discretion. Women assigned to the surgical arm received immediate
surgical evacuations at the study hospital. Analgesics and antibiotics for
participants receiving surgical treatment were given per each facilitys clinical
norms; no anesthesia was used during the procedures.
(Paragraf 6 halaman 2)
Participants were asked to return to the clinic 1 week later to confirm
clinical status. In the event of continued heavy bleeding, an enlarged uterus, or
any suspicion of an ectopic pregnancy, the woman was referred for ultrasound
and follow-up care. If continued incomplete abortion was determined by clinical
exam or by ultrasound in either of the study arms, women were given the option of
an immediate surgical evacuation or returning for additional follow-up 1 week
later to see if expulsion had occurred spontaneously. If, after the second followup
visit, abortion was not complete, a surgical completion was performed. All women

were advised that they could return to the study site at any time if complications
arose, or if they had questions.
(Paragraf 7 halaman 2)

a. Apakah ada kecukupan tindak lanjut?

Apa yang terbaik?
Ya
Komentar

Terdapat

bagian

menunjukan bahwa

paragraf

partisipan

yang

hanya 21 orang yang hilang

pada saaat follow up (< 20%), namun masih tetap

dimasukkan dalam demografik, tapi di eksklusi dari
analisis.

Twenty-one women were lost to follow-up before study completion and

therefore are only included in the demographic analyses. We examined
participant characteristics including age, parity, education, marital status, and
abortion type (spontaneous or induced)
(paragraf 2 halaman 3)

Flowchart halaman 3

4. Measurement : Apakah subjek dan penilai disamarkan terhadap perlakuan

yang diterima dan atau apakah pengukurannya obyektif?
Apa yang terbaik?
Tidak
Komentar

: Blinding/penyamaran penilai outcome (peneliti) tidak

mengetahui pada kelompok subjek tersebut (disamarkan).
Namun subjek tahu di kelompok mana dia berada dan
penelitian ini menggunakan penilaian secara subjektif, dan
penelitian ini adalah single blinded. Sehingga perbedaaan
perilaku pada penelitian ini sulit untuk disamarkan.

Similar study protocols were approved by ethical review boards in each

countrya and all participants gave written, informed consent. The trials included
in this paper are registered as two separate studies on clinicaltrials.gov
(NCT00466999 and NCT01539408).
(Paragraf 5 halaman 2)

Participants were randomly assigned to either one dose of 400 mcg of

sublingual misoprostol (200 mcg tablet 2) (CytotecW, Pfizer, USA) or a
surgical evacuation of the uterus following standard practice at each hospital
(MVA or D&C). (The multicenter sites were randomized together and the two
country-level sites were randomized individually).
(Paragraf 6 halaman 2)

If continued incomplete abortion was determined by clinical exam or by

ultrasound in either of the study arms, women were given the option of an
immediate surgical evacuation or returning for additional follow-up 1 week later
to see if expulsion had occurred spontaneously. If, after the second followup visit,
abortion was not complete, a surgical completion was performed. All women were
advised that they could return to the study site at any time if complications arose,
or if they had questions. Care throughout the study was provided by clinicians at
all levels. In all sites except Mauritania and Nigeria, care was provided by
midwives or nurses. In both these sites, care was mostly given by physicians
although nurses and midwives were involved in counseling and follow-up. Only
some clinicians at the Burkina Faso sites had previous experience with
misoprostol for treatment of incomplete abortion.
(Paragraf 7 halaman 2)

Langkah 3

: Apa makna dari hasil penelitian?

Pengukuran apa yang dipakai dan seberapa besar efek perlakuan?

Uji/Hasil

Sembuh

Tidak

Jumlah

437

28

465

374

374

Jumlah

811

28

839

RR = 0,90
EER (Experimental Even Rate) : 28/465 = 0,06 = 6%

CER (Control Even rate)

: 0/374 = 0%

ARR (perbedaan faktual antara kegagalan terapi E dan C) : (CER-EER) = 0-0,06

= -0,06 = -6%
Perlakuan meningkatkan resiko kegagalan obat
NNT : (1/ARR) = 1/0,06 = 16,6
Butuh perlakuan pada 16 orang untuk mengobati 1 orang dengan abortus
inkompletus.
Dapatkah efek yang terjadi disebabkan oleh faktor kebetulan?
Ya
P value : Tidak dicantumkan
Confidence Interval (CI) = (0,89-0,92)
Hasil menunjukan bahwa tidak terdapat perbedaan besar antara kelompok
perlakuan dengan kelompok kontrol yang signifikan secara statistik karena tidak
lebih dari angka 0.
Kesimpulan
Hasil penelitian menunjukan bahwa tindakan operatif lebih efektif mengobati
abotus inkompletus dibandingkan aplikasi sublingual misoprostol. Namun
pengacakannya tidak dijelaskan, serta tidak ada P value penelitian, dan penelitian
ini menggunakan single blinded. Serta pengukurannya dilakukan secara subjektif
sehingga sulit untuk disamarkan.