Medical abortion - clinical aspects Conférence sur l’avortement par médicament- 16 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 Karolinska University Hospital Department of Women and Child Health Stockholm/Sweden Museum of Contraception and Abortion Vienna, www.muvs.org

The quality of care has therefore a huge impact on the whole society. 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

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 3

Medical abortion - clinical aspects, C. Fiala 4

Mifepristone/Mifegyne® /Mifeprex® www.mifegyne.info Medical abortion - clinical aspects, C. Fiala

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

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

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 Relaxes the uterine muscle Keeps the cervix closed Progesterone Medical abortion - clinical aspects, C. Fiala

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

Mifepristone, prostaglandins and uterine contractility Bygdeman & Swahn 1985 The interval is important for the effectiveness Medical abortion - clinical aspects, C. Fiala

www.who.int/reproductive-health/publications/safe_abortion/safe_abortion.html Medical abortion - clinical aspects, C. Fiala

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

The procedure up to 63 days LMP Website: - information (www.gynmed.org) First contact /telephone: - 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

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 Bleeding becomes heavy Expulsion takes place Beginning of a new cycle/fertility Prostaglandin Expulsion ≠ Abortion Medical abortion - clinical aspects, C. Fiala

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

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 Before miso (hours after misoprostol) unknown uncertain More than 24 h later 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. Source: The New England Journal of Medicine, 1998; 338 (18): 1244 Medical abortion - clinical aspects, C. Fiala

The procedure D 1: CRL 10 mm hCG 83.439 D 8: E 8 mm hCG 312 Medical abortion - clinical aspects, C. Fiala

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

The procedure Day 1: Gestational sac 5 mm hCG 862 Day 3: Day 7: hCG 7 Medical abortion - clinical aspects, C. Fiala

The procedure Day 1: ß-hCG 269 mIU/ml Day 9: ß-hCG 20 Medical abortion - clinical aspects, C. Fiala

The procedure D 1: CRL 6 mm hCG 104.900 D 3: Start OC D 10: E 20 mm, D 17: OC ex D 21: Withdrawl-bleeding D 28: hCG 100 Medical abortion - clinical aspects, C. Fiala

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

Serum hCG at follow-up in % of the initial value 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

Endometrium in ultrasound Thickness of the uterine cavity at follow up Average: 10mm (1-24mm) after successful medical abortion Medical abortion - clinical aspects, C. Fiala Fiala et al. Eur J Obstet Gynecol, 2003

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