Conférence sur l’avortement par médicament16 Septembre 2014 - FQPN
Medical abortion - clinical aspects
Christian Fiala, MD, PhD
www.mifegyne.info
www.misoprostol.org
International Association of Abortion and Contraception Associates
www.fiapac.org
Gynmed Clinic
Vienna, Austria
www.gynmed.at
Museum of Contraception and Abortion
Vienna, www.muvs.org
Karolinska University Hospital
Department of Women and Child Health
Stockholm/Sweden
2
Abortion is the most frequently
performed surgical procedure
in Obstetrics and Gynaecology,
regardless of whether it is illegal or
legal.
The quality of care has therefore
a huge impact on the whole society.
Medical abortion - clinical aspects, C. Fiala
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Marketing of mifepristone
• 1988: France (49 days LMP)
• 1991: UK (63)
• 1992: Sweden (63)
• 1999 January: Austria (49)
• 2000: most other European countries (49)
• 2000: US, Mifeprex® (49)
• 2007: Portugal; all countries up to 63 days
• 2010: Italy
• Now available in 44 countries
Medical abortion - clinical aspects, C. Fiala
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Medical abortion - clinical aspects, C. Fiala
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Mifepristone/Mifegyne® /Mifeprex®
www.mifegyne.info
Medical abortion - clinical aspects, C. Fiala
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Mifepristone
• Steroid competitively blocking hormone receptors
• Affinity to progesterone receptor is 8 times higher than
progesterone
• Affinity to the cortisol receptor is 3 times higher than cortisol
• Fast oral absorption, peak after 1.5 hours
• Half life more than 18 hours
• 3 metabolites, providing 23-33% of the antiprogestagenic
effect in a 600mg dose
Medical abortion - clinical aspects, C. Fiala
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Mifepristone cont.
• Very safe (no death from the drug reported)
• Side effects minimal (nausea)
• Regimen 200-600 mg (1-3 tablets) followed by a
prostaglandin 36-48 hours later
• The interval is important for the effectiveness
• Rather expensive drug: 22€ (United States 85$) per tablet
Medical abortion - clinical aspects, C. Fiala
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Mode of action of progesterone in the uterus
Inhibits the regression of
the corpus luteum
ß-hCG
Gestational
sac
Keeps the endometrium
and the gestational sac
attached to the uterine
wall
Progesterone
Relaxes the uterine
muscle
Keeps the cervix closed
Medical abortion - clinical aspects, C. Fiala
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Mode of action of mifepristone
Leads to the regression
of the corpus luteum
Decreases
ß-hCG
Blocks the receptors
of progesterone
Gestational
sac
The endometrium and the
gestational sac separates from
the uterine wall
The uterine muscle becomes
more sensitive to prostaglandin
and contracts
The cervix opens
Blocks progesterone receptors and thereby induces the clinical symptoms
identical and indistinguishable to a miscarriage (corpus luteum insufficiency)
Medical abortion - clinical aspects, C. Fiala
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Mifepristone, prostaglandins and uterine contractility
Bygdeman & Swahn 1985
The interval is important for the effectiveness
Medical abortion - clinical aspects, C. Fiala
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www.who.int/reproductive-health/publications/safe_abortion/safe_abortion.html
Medical abortion - clinical aspects, C. Fiala
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Mifepristone: approved indications in Europe
• Voluntary medical abortion <63 days in
combination with a prostaglandin
(misoprostol/gemeprost)
• Priming of the cervix prior to surgical abortion
• Medical abortion for medical indications in the 2. +
3. Trimester
• Induction of labour in intrauterine foetal death
Medical abortion - clinical aspects, C. Fiala
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The procedure up to 63 days LMP
Website:
First contact /telephone:
- information (www.gynmed.org)
- Is pregnancy confirmed?
- Has the patient been able to talk to someone close?
- Has the decision for the abortion been taken?
- Answer questions or refer to the website
- Exclude contra indications
- Make appointment
Day 1:
- Ultrasound, hCG (gynaecological examination)
- Blood group
- Counselling: abortion only if the decision is clear
otherwise give an appointment one week later
- 1 or 3 tab mifepristone
Day 3:
- <49 days LMP = 2 tab misoprostol (Cytotec®) orally
50-63 days LMP = 4 tab misoprostol vaginaly
- Option for up to 3 hours in the institution (rarely used)
- Make sure patient has sufficient analgesics
- Start oral contraception the next day
Day 8 -14:
- ultrasound and/or hCG
Medical abortion - clinical aspects, C. Fiala
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When does the abortion take place?
Phase of psychological confrontation Phase of coming to a decision
Mifepristone
The abortion/Point of no return
• Detachment of the gestational sac
• Bleeding may start
• Expulsion may take place
Prostaglandin
• Bleeding becomes heavy
• Expulsion takes place
• Beginning of a new cycle/fertility
Expulsion ≠ Abortion
Medical abortion - clinical aspects, C. Fiala
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Medical abortion: impact of the interval
Mifepristone
Misoprostol
36-48 hours
Reducing the interval needs a higher dose of prostaglandin > more side effects
Medical abortion - clinical aspects, C. Fiala
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When does the expulsion take place?
in %
20
15
10
5
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16 17 18 19
20 21
22 23 24
(hours after misoprostol)
Time to expulsion of the sac in 1720 women with successfull termination of
pregnancy. The women took mifeprostone on day 1 and misoprostol 48 hours
later. Uncertain means expulsion at some point during 24 hours following
misoprostol. Unknown means expulsion at some point later than 24 after
misoprostol.
Medical abortion - clinical aspects, C. Fiala
Source: The New England Journal of Medicine, 1998; 338 (18): 1244
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The procedure
D 1: CRL 10 mm
hCG 83.439
D 8: E 8 mm
hCG 312
Medical abortion - clinical aspects, C. Fiala
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The procedure
Day 1: hCG 32.000
yolk sac visible
Day 3: Gestational sac
Day 8: E 12 mm
hCG 837
Medical abortion - clinical aspects, C. Fiala
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The procedure
Day 1: Gestational sac
5 mm
hCG 862
Day 3:
Gestational sac
Day 7: hCG 7
Medical abortion - clinical aspects, C. Fiala
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The procedure
Day 1: ß-hCG 269 mIU/ml
Day 9: ß-hCG 20
Medical abortion - clinical aspects, C. Fiala
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The procedure
D 1: CRL 6 mm
hCG 104.900
D 3: Start OC
D 10: E 20 mm,
hCG 16.841
D 17: OC ex
D 21: Withdrawl-bleeding
D 28: hCG 100
Medical abortion - clinical aspects, C. Fiala
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The procedure
D 1: Gestational +
yolk sac
hCG 13.300
D 3: Start OC
D 9: missed AB
hCG 10.819
D 16: OC ex
D 18: Withdrawl-bleeding
D 19: E 8 mm
hCG 718
Medical abortion - clinical aspects, C. Fiala
hCG before and after an abortion
,
,
,
,
,
,
,
Top curve: women after vacuum aspiration for elective abortion
Middle curve: women with spontaneous abortions uterine aspiration
Lower curve: women with ectopic removed surgically
Medical abortion - clinical aspects, C. Fiala
Montagnana et al., Clinica Chimica Acta, 2011
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24
Serum hCG at follow-up in % of the initial value
20
%
15
10
5
days
0
0
2
4
6
8
10
12
14
16
18
Mean 3,8% (0,1-44); the size of the circles correlates with the number of patients. The smallest circles
represent 1 patient; the biggest represent 25 patients,
Fiala et al., 2003
3 cs of successful abortion were at 27,32 and 44%,
2 cs of missed abortion at 91 and 159%,
1 cs of continued pregnancy 7.900 %
Medical abortion - clinical aspects, C. Fiala
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25
Endometrium in ultrasound
mm
30
25
20
15
10
5
0
0
2
4
6
8
10
12
14
16
18
Days
Thickness of the uterine cavity at follow up
Average: 10mm (1-24mm) after successful medical abortion
Fiala et al. Eur J Obstet Gynecol, 2003
Medical abortion - clinical aspects, C. Fiala
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A new
training CD
and manual
Can be ordered at: arms@armsinc.org
New Museum wants
old contraceptives
Museum of Contraception
and Abortion
www.muvs.org
Vienna
Wanted:
Objects (IUDs,
Cervical caps
etc.), Reports,
posters,
publications
Reproductive Health a Gender Problem
Carrying
the burden of
reproduction...
What about
sharing rights
including the
right to
exercise them?
2014