Evidence Based Medicine dalam

Penggunaan AVM dan Medikamentosa

dalam Praktek Obstetri dan
Ginekologi
dr. Detty Siti Nurdiati, MPH.,Ph.D ., SpOG(K)

Division of Maternal Perinatal Medicine, Department of Obstetrics & Gynecology

1

Faculty of Medicine, Public Health & Nursing, Universitas Gadjah Mada

2Clinical Epidemiology and Biostatistics Unit

Faculty of Medicine, Public Health & Nursing, Universitas Gadjah Mada

3
Cochrane Indonesia
Introduction
Evidence Based Medicine

Best research Evidence Evidence

evidence Based Based
Clinical Medicine Practice/
Epidemiology Health
Care

Patient values,
needs and Clinical expertise
circumstances
Evidence Based Medicine
• To improve the quality of the
information on which health care
decisions are based.
• To avoid ‘information overload’
but, at the same time, to find
and apply the most useful
information.
• ‘Evidence’
• Is empirical evidence, what
actually works or doesn’t work in
practice.
• Is not scientific evidence for a
mechanism of action (such as a
biochemical pathway, physiological
effect or anatomical feature).
• EBP is concerned with actual
clinical outcomes
 Why do we need EBM?
But….
“Busy clinicians are now caught in an
information paradox —
overwhelmed with information but
unable to find the knowledge they
need when they need it …
The truth is that information cannot
be dealt with by individuals alone.
The organisation in which individual
clinicians work has to manage
knowledge as well as it manages its
other resources.”
JA Muir Gray, BMJ 1998;317:832

http://i.istockimg.com/file_thumbview_approve/50086850/3/stock-illustration-50086850-busy-
In 1944, while Dr. Burwell was Dean at Harvard
Medical School (1935-1949), women entered
Harvard Medical School for the first time on an
equal basis with men.  In an address to
students at the Medical School, he said:

“Half of what we are going to

teach is wrong, and half of it is
right. Our problem is that we Charles Sidney Burwell
Cardiologist
don’t know which half is which.” (1893-1967)

http://nrs.harvard.edu/urn-3:HUAM:DDC109960_dynmc?
width=560&height=560
6
 GRADE approach for synthesizing evidence

 


4 categories for quality of evidence

 GRADE approach for synthesizing evidence
Systema
tic
reviews
& meta-
Study design analyses
*

Experimental
RCTs start

e
nc
Randomized Controlled

de
Observational studies start Studies

Evi
of
gth
Cohort Studies

en

Observational
Str
Case control studies

Case series/reports

Expert opinions, Editorials

Chart adapted from

Burns P, Rohrich R, Chong K. The Levels of Evidence and their role in Evidence-Based Medicine. Vol. 128, Plast Reconstr
Surg. 2011. p. 305–10.
 Determinants of quality of evidence
Quality Study design Lower quality if: Higher quality if:

High Randomised Risk of bias (-1, -2) Large effect

(++++) controlled trials (+1, +2)
Inconsistency(-1, -2)
Dose-response
Moderate Indirectness (-1, -2) (+1)
(+++)
Imprecision (-1, -2) Direction of residual
Low Observational confounding and biases
(++) studies Publication bias (-1, -2) (+1)

Very low Case reports,

(+) expert opinion,
modelling
 A schematic view of the GRADE approach for developing recommendations

2 categories for quality of evidence

Strong recommendations
Weak recommendations
‘conditional (Weak/Strong) (For/Against) and intervention’
 GRADE approach for developing
recommendations
Key factors determine the strength of recommendation

Balance between desirable and undesirable 01

Quality of evidence 02
Values and Preferences 03
Cost (resources) 04
Definition and Scope of Care
 Post Abortion Care
• Women centered care for any pregnancy less than
13 weeks gestational age with
• Incomplete abortion
• Missed abortion

• Blighted ovum (?)

• Hydatid Mole (?)
 Scope of Care
• Vacuum aspiration or medical abortion should
replace sharp curettage (also known as dilatation
and curettage [D&C]) for the treatment of abortion
and postabortion care (FIGO, 2011; WHO, 2012).

• A 2010 Cochrane review (Tuncalp, Gulmezoglu, & Souza,

2010)showed that vacuum aspiration is as effective as
sharp curettage in treating incomplete abortion while:
• reducing procedure time,
• reducing blood loss and
• reducing pain.
Strength of recommendation: Strong
Quality of evidence: Moderate
 Scope of Care
• Retrospective case series (80,437 women seeking
induced abortion: showed vacuum aspiration was
associated with less than half the rate of major and
minor complications compared to sharp curettage
(Grimes, Schulz, Cates Jr, & Tyler Jr., 1976).
• A more recent series (>100,000 abortion procedures)
found that sharp curettage performed alone or in
combination with vacuum aspiration was significantly
more likely to be associated with complications,
particularly incomplete abortion, than vacuum
aspiration without curettage (Sekiguchi, Ikeda, Okamura,
& Nakai, 2015).
Strength of recommendation: Strong
Quality of evidence: Moderate
 Scope of Care
• Vacuum aspiration and medical abortion are safe
and effective for adolescent and adult women
• The success rates have not been disaggregated by
age.

Strength of recommendation: Strong

Quality of evidence: Moderate
 Providers
• Many cadres of trained health workers can provide
vacuum aspiration and medical abortion before 13
weeks gestation as safely and effectively as
physicians.

• Non-specialist doctors, associate and advanced

associate clinicians, midwives and nurses can be trained
to perform vacuum aspiration and provide medical
abortion (WHO, 2015).

Quality of evidence: High

 Providers
• In settings where there are established mechanisms to
include auxiliary nurses and auxiliary nurse midwives in
basic emergency obstetric care or postabortion care,
these cadres can also perform vacuum aspiration.
• Where doctors of complementary medicine participate
in other tasks related to maternal and reproductive
health, they can also perform vacuum aspiration and
medical abortion.
• WHO recommends against provision of vacuum
aspiration and medical abortion by pharmacists,
pharmacy workers or lay health providers.

Quality of evidence: High

Preparation Considerations
 Gestational Age
• Should be assessed before provision of abortion
services, using:
• a woman’s last menstrual period (LMP) combined with
bimanual examination;
• ultrasound may be useful when gestational age is
unclear or there is a discrepancy between the two
estimates.
• Routine use of ultrasound for gestational age
determination is not necessary.

Strength of recommendation: Strong

Quality of evidence: Moderate
 Bimanual Examination
• Bimanual examination must be performed before
any procedure in which instruments are being
placed in the uterus, such as vacuum aspiration or
intrauterine device insertion.
• The bimanual examination must be performed by
the clinician doing the procedure.

Strength of recommendation: Strong

Quality of evidence: Very Low
Manual Vacuum Aspiration
 Safety and Effectiveness
• Vacuum aspiration is effective and safe
• Success rates >98%
• Major complication rates <1%

• A systematic review by White, Carroll & Grossman (2015)

• analyzed 57 studies in North America, Western Europe,
Scandinavia and Australia/New Zealand
• 337,460 aspiration abortions performed <14 weeks gestation
• Major complications requiring intervention (such as hemorrhage
requiring transfusion or perforation necessitating repair) occurred
in ≤ 0.1% of procedures; hospitalization was necessary in ≤ 0.5% of
cases.
Quality of evidence: High
 Safety and Effectiveness
• Studies looking at different cadres of providers
(physician assistants, nurses, nurse midwives, etc.) in
other settings have had similar results (Hakim-Elahi,
Tovell, & Burnhill, 1990; Jejeebhoy et al., 2011; Warriner
et al., 2006; Weitz et al., 2013).
• In two studies that compared newly trained midlevel
providers to experienced physician providers (Jejeebhoy
et al., 2011; Weitz et al., 2013), there were no observed
differences in abortion success or complication rates.

Quality of evidence: High

 Prophylactic Antibiotics
• Administer prophylactic antibiotics prior to vacuum
aspiration.
• Where antibiotics are unavailable, uterine evacuation
procedures should still be offered.
• Administer treatment doses of antibiotics to those with
signs or symptoms of sexually transmitted infection;
partners of individuals with sexually transmitted
infections also require treatment. Treatment should not
delay uterine evacuation.

Strength of recommendation: Strong

Quality of evidence: High
Common regimens Recommender

Doxycycline 200mg orally before the procedure

or
Azithromycin 500mg orally before the procedure ​PPFA, 2016
or 
Metronidazole 500mg orally before the procedure

Doxycycline 200mg orally no more than 2 hours before

the procedure
or RCOG, 2015
Azithromycin 500mg orally no more than 2 hours
before the procedure

Doxycycline 200mg orally within 1 hour before

procedure ACOG, 2018
 Pain Management
• A combination of paracervical block and preprocedure
nonsteroidal anti-inflammatory drugs (NSAIDs) for pain
management is recommended for all women.
• Additional measures such as narcotic analgesics, anxiolytics and
non-pharmacologic pain management measures may be helpful.
• Intravenous sedation, where available, may be offered.
• Paracetamol is not effective for vacuum aspiration pain
management.
• General anesthesia is not routinely recommended for vacuum
aspiration pain management.

Strength of recommendation: Strong

Quality of evidence: Moderate
 Cervical Preparation
• Cervical preparation is recommended after 12-14 wga.
• Before 12-14 wga, cervical preparation may be
considered, but should not be routinely used.
• Recommended methods for cervical preparation
include:
• Misoprostol 400mcg sublingually 1-3 hours before
• Misoprostol 400mcg vaginally or buccally 3 hours before
• Osmotic dilators placed in the cervix 6-24 hours before
• Mifepristone 200mg orally 1-2 days before

Strength of recommendation: Strong

Quality of evidence: Moderate
Benefit
• A meta-analysis of 51
randomized controlled clinical
trials of cervical preparation
through 13 weeks gestation
found that procedure time was
shorter with cervical
preparation but there were no
differences in serious
complications, such as cervical
laceration or uterine
perforation, in women given
cervical preparation compared
to those given placebo (Kapp,
Lohr, Ngo, & Hayes, 2010).
 
Side effect
• In the largest randomized
controlled trial of misoprostol
for cervical preparation, 55%
of women who took
misoprostol complained of
pre-procedure abdominal
pain and 37% had vaginal
bleeding, compared to 22%
and 7% in the placebo group
(Meirik et al., 2012).
• In addition, cervical
preparation adds cost,
complexity and time to an
abortion (Kapp et al., 2010).
 Examining Product of Conception
• Clinicians performing vacuum aspiration must
inspect products of conception immediately after
vacuum aspiration.
• Sending products of conception for routine
histopathology evaluation is not recommended.

Strength of recommendation: Strong

Quality of evidence: Very Low
 Processing Manual Vacuum Aspirators
• All multiple-use aspirators and adapters must be
soaked, cleaned and high-level disinfected or
sterilized between patients.
• Step 1: Point-of-use preparation
• After use, do not let the device dry. Presoak, rinse or spray the
device with water or enzymatic spray. Do not use chlorine or
saline.
• Step 2: Cleaning
• Disassemble aspirator and adaptor (if used) and clean with warm
water and detergent using a soft brush.
• Step 3: Sterilization or high-level disinfection
• All aspirators and adaptors must be sterilized or high-level
Best practice disinfected after use.
Medical Abortion
 Safety and Effectiveness
• A combined regimen of mifepristone and
misoprostol is effective and safe
Combined Mife-Miso
Rate ~ 10 wga 10-13 wga
Success >95% >95%
Continuing pregnancy <2% <2%
Complication <1% 3%

Quality of evidence: High

 Safety and Effectiveness
• A combined regimen of mifepristone and
misoprostol is recommended for medical abortion;
where mifepristone is not available, the
misoprostol-only regimen may be used.
Combined Mife-Miso Miso only
Rate ~ 10 wga 10-13 wga ~13 wga
Success >95% >95% 80-85%
Continuing pregnancy <2% <2% 3-10%
Complication <1% 3% 1-4%

Quality of evidence: High

 Route of Delivery
Combined Mifepristone and Misoprostol
~ 10 wga 10-13 wga
• Mifepristone 200mg orally • Mifepristone 200mg orally
• Followed 1-2 days later by • Followed 1-2 days later by either misoprostol
misoprostol 800mcg 600mcg sublingually or 800mcg vaginally
buccally, sublingually or • Then 400mcg sublingually or vaginally every
vaginally. three hours until expulsion.

• Mifepristone 200mg orally

• Followed 1-2 days later by misoprostol
800mcg buccally, sublingually or vaginally
• The dose of misoprostol may be repeated to
achieve abortion success.

Strength of recommendation: Strong

Quality of evidence:
• ~10 wga: High
• 10-13 wga: Low
 Route of Delivery
Misoprostol only
~ 13 wga
• Misoprostol 800mcg buccally, sublingually or
vaginally every three hours until expulsion.

Strength of recommendation: Strong

Quality of evidence:
• ~9 wga: Moderate
• 9-13 wga: Low
 Home Use
• Women may take mifepristone in a facility or at
home.
• Home use of misoprostol following mifepristone or
in a misoprostol-only regimen may be offered up to
10 weeks gestation.
• After 10 weeks gestation, misoprostol should be
used in a facility.
Strength of recommendation: Strong
Quality of evidence:
• ~10 wga: Moderate
• 11-13 wga: Very Low
 Incomplete and Missed Abortion
• Incomplete abortion: 
Misoprostol 600mcg orally in a single dose or 400mcg in a
single dose sublingually or, in the absence of vaginal
bleeding, vaginally.
• Missed abortion: 
Misoprostol 600mcg sublingually or, in the absence of
vaginal bleeding, 800mcg vaginally every three hours until
pregnancy expulsion (generally 1-3 doses). Where
available, add pretreatment with mifepristone 200mg
orally 1-2 days before misoprostol.
Strength of recommendation: Strong
Quality of evidence: Moderate
 Risk of Fetal Malformation
• Exposure to mifepristone alone has not been
shown to cause fetal malformations.
• Exposure to misoprostol is associated with a small
increased risk of malformations if the woman has
an ongoing pregnancy and decides not to terminate
(<10 per 1000 exposures).
• Women with an ongoing pregnancy after using
misoprostol should be counseled about the risk if they
choose to carry the pregnancy to term.
Strength of recommendation: Strong
Quality of evidence: Very Low
 Prophylactic Antibiotics
• Routine use of antibiotics is not recommended for
women undergoing medical abortion.
• Administer treatment doses of antibiotics to those
with signs or symptoms of sexually transmitted
infection. Partners of individuals with sexually
transmitted infections also require treatment.
Treatment should not delay medical abortion.

Strength of recommendation: Weak

Quality of evidence: Very Low
 Pain Management
• Offer pain medication to all women undergoing medical
abortion (~13 wga).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) are
recommended either prophylactically or at the time
cramping begins.
• Narcotic analgesics and non-pharmacologic pain
management measures may be helpful.
• Paracetamol should not be used unless an allergy or
contraindication to NSAIDs exists.
Strength of recommendation: Strong
Quality of evidence: Low
 Confirmation of Success
• Abortion with a combined mifepristone and
misoprostol have a successful abortion; routine
follow-up is not required.
• Misoprostol-only regimen for medical abortion
need follow-up with a clinician to ensure the
abortion was successful.
• Providers may perform a clinical assessment to assist in
the confirmation of successful abortion.
• Ultrasound or other testing is needed only in cases
where the diagnosis is unclear.

Strength of recommendation: Strong

Quality of evidence: Moderate
 Thank you
List of literatures could be requested by email to: dnurdiati@yahoo.com