Avortement médical ou médicamenteux Édith Guilbert M.D., M.Sc. FQPN, Internet,16 septembre 2014

IVG médicale au Canada Lieu IVG médicale IVG chirurgicale IVG mixte Canada ICIS 2011 3,7% 93,8% 2,3% Canada Enquête 2013 4% (1%) 96% (99%) - 59,3% faits par des médecins généralistes 79,7% sont des femmes 63,3% vont jusqu’à 49 jours de gestation US CDC 2010 17,8% 80,5% 1,9% US Enquête 2013 35,6% 64,4% 56% faits par des médecins (3/4 sont des spécialistes), 26% par des nurses practitioners, 6% par des infirmières 78,7% sont des femmes 79,1% vont jusqu’à 63 jours de gestation

IVG médicale au Québec On la pratique approximativement depuis 1998. On utilise off label : Misoprostol seul, 800 g qq jours plus tard, intravaginal ou buccal, pour 1-2 doses Methotrexate 50 mg/m2 IM ou 50 mg per os ET Misoprostol 800 g qq, 1-7 jours plus tard, intravaginal ou buccal, pour 1-2 doses à 24 heures de distance Environ une quinzaine de médecins de 3-4 cliniques font cette pratique actuellement au Québec

Efficacité comparée du Méthotrexate/ Misoprostol vs Efficacité comparée du Méthotrexate/ Misoprostol vs. Mifepristone/Misoprostol When mifepristone regimens are compared with methotrexate regimens, both achieve similar success rates for pregnancies up to 49 days’ gestation.1 The combination of mifepristone and misoprostol, however, tends to require less time than methotrexate/misoprostol to achieve expulsion of the pregnancy.2 The data from two medical abortion studies conducted by Schaff and colleagues3,4 highlight this difference. Methotrexate is widely available and is generally inexpensive (especially the oral formulation). Mifepristone must be ordered directly through specific distributors after providers sign a prescriber’s agreement and file it with the distributor. Refs: 1 Kahn JG, Becker BJ, MacIsaac L, et al. The efficacy of medical abortion: a meta-analysis. Contraception 2000;61:29-40. 2 Creinin MD, Spitz IM. Use of various ultrasound criteria to evaluate the efficacy of mifepristone and misoprostol for medical abortion. Am J Obstet Gynecol 1999;18:1419-1424. 3 Schaff EA, Eisinger SH, Stadalius LS, Franks P, Gore BZ, Poppema S. Low-dose mifepristone 200 mg and vaginal misoprostol for induced abortion. Contraception 1999;59:1-6. 4 Schaff EA, Eisinger SH, Franks P, Kim S. Methotrexate and misoprostol for early abortion. Fam Med 1996;28:198-203. Schaff, et al. Fam Med 1996 Schaff, et al. Contraception 1999

Taux d’échec: 5% à 16% (Mife&Miso) Comparaison de l’efficacité des méthodes chirurgicale et médicale pour l’IVG précoce Étude Efficacité IVG chirurgicale Efficacité IVG médicale Creinin MD, Contraception 2000 (I) :  49 jours Après 2 semaines 96% 83% (Metho&M) Henshaw RC et al, Hum Reprod 1994 (I) :  49 jours 98% 98% (Mife&Gemeprost) Winikoff B et al, Am J Obstet Gynecol 1997 (II) :  56 jours Taux d’échec: 0% à 4% Taux d’échec: 5% à 16% (Mife&Miso) Jensen JT et al, Contraception 1999 (II) :  49 jours 87% (Mife&M) Bender N et al, Contraception 2011 (II) :  63 jours Grossesse: 0,1% Avort. Incompl.: 0,7% Grossesse: 0,3% (Mife&M) Avort. Incompl.: 1,3% SFP: Clinical Guidelines: Surgical abortion prior to 7 weeks of gestation, 2013.

L’avortement médical : Permet d’éviter une intervention chirurgicale et une anesthésie Est considéré comme plus naturel et intime Requiert au moins 2 visites et des analgésiques Prend plusieurs jours à se compléter (Métho-Miso) A un haut taux de succès (98%) Requiert un suivi pour vérifier que l’avortement est complet Requiert une plus grande participation de la patiente tout au long de la procédure Fait en sorte que la femme peut vivre son IVG seule Moins coûteux que l’IVG chirurgicale In contrast to early surgical abortion, medical abortion allows the patient to avoid an invasive procedure (except in the approximately 5% of cases in which the procedure is not successful).1 Women who opt for a medical abortion often cite the desire to avoid an invasive procedure as a major factor in their decision.1,2 Unlike surgical abortion, medical abortion requires two or more visits to the healthcare provider, and the process typically takes anywhere from a few days to a few weeks to complete. The total number of visits required may vary depending on the protocol employed and state regulations. Success in medical abortion is defined as complete abortion without surgical intervention. The overall success rate—approximately 95%—is somewhat lower for medical abortion compared to the surgical approach, but for women interested in avoiding an invasive procedure, this high success rate is likely to be an appealing feature. While surgical abortion may not require a follow-up evaluation, medical abortion always requires follow-up to ensure completion of the abortion.3 Lastly, medical abortion allows the patient to be involved in the process and to have some control. In an era of patient empowerment, this feature may appeal to many women. Some women may feel that because medical abortion involves using medications rather than undergoing a surgical procedure, it affords greater privacy. For other women, the fact that medical abortion can be associated with gastrointestinal (GI) symptoms and pain may make it difficult to conceal that they are experiencing the equivalent of a (medically induced) miscarriage in their home setting. In some instances, a surgical abortion, because it is performed during a relatively brief office visit, may in fact be more private than a medical abortion. Refs: 1Kahn JG, Becker BJ, MacIsaac L, et al. The efficacy of medical abortion: a meta-analysis. Contraception 2000;61:29-40. 2Creinin MD, Burke AE. Methotrexate and misoprostol for early abortion: a multicenter trial. Contraception 1996;54:19-22. 3Wiebe ER. Choosing between surgical abortions and medical abortions induced with methotrexate and misoprostol. Contraception 1997;55:67-71.

L’avortement chirurgical : Est une procédure invasive Ne requiert qu’une à deux visites, en général Est complété dans une période de temps précise A un haut taux de succès (99,9%) Ne requiert pas nécessairement de suivi Requiert la participation de la femme dans une procédure unique Est fait par un professionnel de la santé Peut être fait sous sédation-analgésie ou anesthésie générale Est associé à un risque faible de traumatisme gynécologique et d’infection Potential advantages of early surgical abortion compared with medical abortion include1: A shorter procedure that is complete in a predictable period of time—typically in one day (in contrast, medical abortion may take days to weeks to complete) Fewer office visits (the number of visits may vary according to state regulations) Higher reported success rate: 99% for early surgical abortion2 compared to approximately 95% for medical abortion3 Follow-up is recommended but not mandatory Patient participation in a single-step procedure Ability to use sedation for the procedure, if desired Refs: 1 MacIsaac L, Darney P. Early surgical abortion: an alternative to and backup for medical abortion. Am J Obstet Gynecol 2000;183(suppl):S76-S83. 2 Edwards J, Creinin MD. Surgical abortion for gestations of less than 6 weeks. Curr Problems Obstet Gynecol Fertil 1997;20:11-19. 3 Kahn JG, Becker BJ, MacIsaac L, et al. The efficacy of medical abortion: a meta-analysis. Contraception 2000;61:29-40.

Évaluation pour une IVG au Méthotrexate-Misoprostol Counseling Consentement éclairé Évaluation médicale Vérification des critères d’éligibilité Examen physique & échographie, tests Remise de la médication et explications des symptômes d’avortement / effets secondaires Mesures d’urgence Suivi nécessaire avec échographie ou -HCG sérique

Complications de l’avortement médical Grossesse évolutive (1-3% < 49 jours) Persistance du sac gestationel (2.9% < 49 jours) Saignement persistant requérant un curetage (variable) Hémorrhagie requérant un curetage (0.36%-2.6%) ou une transfusion (0%-0.48%) Infection pelvienne (0.09%-0.5%) Grossesse ectopique non diagnostiquée (0.67%) A continuing, viable pregnancy detected at the follow-up visit after treatment with medical abortion agents constitutes a method failure and requires suction curettage to end the pregnancy. The term “incomplete abortion” has been used in some medical abortion studies to collectively describe conditions, specifically persistent nonviable gestational sac or persistent bleeding requiring surgical intervention, in which symptoms or ultrasound findings suggest the failure to expel all pregnancy tissue. Persistent gestational sac is diagnosed when there is a failure to completely expel the gestational sac—an outcome that may require surgical evacuation. Protocols generally specify a certain period of time after which a persistent gestational sac is considered an “incomplete abortion” and therefore requires surgical evacuation. This defined period of time can vary with different protocols, but has generally ranged from 2 to 5 weeks post-mifepristone administration. Women with a persistent gestational sac do not always have symptoms, such as persistent or heavy bleeding. A woman experiencing persistent, heavy bleeding is often presumptively diagnosed with retained pregnancy tissue or persistent gestational sac. Serious hemorrhage is quite rare following medical abortion. The occasional patient who reports saturating 2 or more maxipads per hour for 2 consecutive hours should contact her provider to determine the need for clinical evaluation.1 The need for intervention to treat hemorrhage following medical abortion with mifepristone/misoprostol varies with gestational age and route of misoprostol administration. In a study by Ashok and colleagues2 in which 2,000 women received 200 mg of mifepristone orally followed by 800 µg of misoprostol vaginally, seven women (0.35%) required uterine evacuation to control bleeding. In the multicenter American trial reported by Spitz and colleagues3 involving a regimen of 600 mg of mifepristone orally followed by 400 µg of misoprostol orally, 2.6% of 2,121 women required suction curettage to treat excessive bleeding. In this trial, the risk of needing surgery, hospitalization, or intravenous fluid therapy was twice as great for women past 49 days’ gestation as for those at 49 days or less (4% versus 2%). The percentage of women requiring transfusion has been reported as 0.2% in three large trials.2-4 Uterine infection (endometritis) is exceedingly rare following medical abortion, most likely because the procedure does not involve instrumentation of the uterus. Most medical abortion studies report no cases of infection. In trials involving over 500 participants, reported rates of endometritis range from 0.09% to 0.5%.5 Ectopic pregnancy is a complication of pregnancy itself and not a complication resulting from medical abortion treatment. Given that patients seeking medical abortion present to their providers early in pregnancy, the critical time for diagnosis of ectopic gestation, medical abortion providers must remain vigilant for the possibility of ectopic pregnancy and should have protocols in place for diagnosis and management. Interestingly, for reasons that remain obscure, the rate of ectopic pregnancy in women presenting for early abortion is much lower than the rate of 1.9% for all pregnancies in the United States. The combination of mifepristone with misoprostol will not effectively treat ectopic pregnancy. In contrast, medical treatment of early ectopic pregnancy with methotrexate is 90% to 95% effective.6,7 Refs: 1 Schaff EA, Eisinger SH, Stadalius LS, Franks P, Gore BZ, Poppema S. Low-dose mifepristone 200 mg and vaginal misoprostol for abortion. Contraception 1999;59:1-6. 2 Ashok PW, Penney GC, Flett GM, Templeton A. An effective regimen for early medical abortion: a report of 2000 consecutive cases. Hum Reprod 1998;13:2962-2965. 3 Spitz IM, Bardin CW, Benton L, Robbins A. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998;338:1241-1247. 4 Winikoff B, Sivin I, Coyaji KJ, et al. Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone-misoprostol versus surgical abortion. Am J Obstet Gynecol 1997;176:431-437. 5 Kruse B, Poppema S, Creinin MD, Paul M. Management of side effects and complications in medical abortion. Am J Obstet Gynecol 2000;183(suppl):S65-S75. 6 Thoen LD, Creinin MD. Medical treatment of ectopic pregnancy with methotrexate. Fertil Steril 1997;68:727-730. 7 Lipscomb GH, Bran D, McCord ML, Portera JC, Ling FW. Analysis of three hundred fifteen ectopic pregnancies treated with single-dose methotrexate. Am J Obstet Gynecol 1998;178:1354-1358.

Critères d’intervention chirurgicale dans l’avortement médical Grossesse évolutive Avortement incomplet ne répondant pas au traitement médical Hypotension orthostatique Anémie, en particulier lors de pertes sanguines abondantes et continues Femme n’ayant pas accès à des services d’urgence Symptômes (douleurs, nausées, vomissements, etc…) ne répondant pas au traitement médical Désir de la femme All medical abortion providers should be able to provide surgical intervention or have plans in place to refer patients in need of surgical intervention to others. As part of the prescriber’s agreement for mifepristone, the provider must be able to perform surgical intervention or have made plans for that care to be provided through others when necessary. The decision to proceed with suction curettage will depend on the patient’s medical condition and the provider’s experience and judgment. Nonclinical factors, such as the patient’s need for child care and transportation, should also be considered. Continuing pregnancy and incomplete abortion unresponsive to medical treatment (i.e., additional misoprostol) are appropriate indications for surgical management. Kruse and colleagues1 have proposed additional indications for surgical intervention, including: Orthostatic hypotension Anemia, especially with ongoing blood loss Patient unable to return for further evaluation or has no access to emergency services Subjective symptoms unresponsive to medical treatment Patient clearly prefers to complete the abortion by aspiration Ref: 1 Kruse B, Poppema S, Creinin MD, Paul M. Management of side effects and complications in medical abortion. Am J Obstet Gynecol 2000;183(suppl):S65-S75.

Satisfaction des femmes Étude sur l’acceptabilité de Metho & Miso (Creinin, 1996): 74,4% des femmes: expérience favorable 48,4% voulaient éviter la chirurgie 83,5% répéteraient l’expérience si besoin RCT sur la satisfaction IVG Chir vs IVG Med (Rorbyel, 2005): Choix: Satisfaction plus grande avec IVG Chir (92% vs 82%) RCT: Satisfaction plus grande avec IVG Chir (94% vs 68%) Satisfaction pour IVG Med inversement corrélée à durée gestationnelle Une américaine sur 3 à 4 qui a une IVG obtient une IVG médicale Creinin MD, Burke AE. Contraception 1996;54:19-22. Rorbyel C, Norgaard M, Nilas L. Human Reproduction 2005;20(3):834-8.

Satisfaction des professionnel-le-s Études sur le sujet??? Au Québec, l’IVG médicale est peu utilisée car: Les femmes ne sont pas au courant et ne le demandent pas. Les professionnel-le-s trouvent que le counseling à faire est trop long ou sont mal à l’aise avec cette approche Efficacité retardée du Metho & Miso Symptômes d’avortement et effets secondaires vs sédation- analgésie de l’IVG chirurgicale Dans certaines cliniques, jusqu’à 50% des femmes ont un curetage de révision… (Étude IVG 2013) Utilisation off label de produits Pas de code RAMQ et certains s’y opposent Culture pro IVG chirurgicale

OFFRE-T-ON UN VÉRITABLE CHOIX AU CANADA????

Conclusion Avant 7 semaines de gestation, l’IVG chirurgicale est légèrement plus efficace que l’IVG médicale. L’IVG médicale avec Méthotrexate et Misoprostol est un processus plus long que l’IVG chirurgicale. Par contre, l’IVG médicale est associée à un moins grand interventionnisme des intervenants de la santé, à un risque infectieux moindre et à une plus grande intimité. Lorsque les deux approches sont disponibles et que les critères d’éligibilité le permettent, le choix de l’approche d’IVG revient à la femme.