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MISOPROSTOL-ONLY REGIMENS FOR MEDICAL ABORTION

MISOPROSTOL-ONLY REGIMENS FOR MEDICAL ABORTION. Department of Reproductive Health and Research World Health Organization Geneva. HELENA VON HERTZEN. MISOPROSTOL. Synthetic analogue of naturally occurring prostaglandin E 1

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MISOPROSTOL-ONLY REGIMENS FOR MEDICAL ABORTION

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  1. MISOPROSTOL-ONLY REGIMENSFOR MEDICAL ABORTION Department of Reproductive Health and Research World Health Organization Geneva HELENA VONHERTZEN

  2. MISOPROSTOL • Synthetic analogue of naturally occurring prostaglandin E1 • Approved in >80 countries (prevention and treatment of gastric and duodenal ulcers; Brazil, Egypt, France also other indications) • Safe and well tolerated • Tablets can be kept at room temperature when packed in aluminium blisters HvH FIAPAC MOSCOW OC.20052

  3. Mean plasma concentrations of misoprostol acid over time with oral and vaginal administration HvH FIAPAC MOSCOW OC.20053

  4. HvH FIAPAC MOSCOW OC.20054

  5. INDUCING EARLY ABORTIONOral misoprostol • Study Regimen N Gestational Success age (wks) • Rabe et al.(1987) 0.4mg x 2 100 9 -12 11% • 0.2mg x 2 100 9 -12 9% • Norman et al.(1991) 0.2mg – 0.6mg 40 <=8 5% • Blanchard et al.(2005) 0.4mg x 4 36 <=8 39% • 0.8mg x 2 24 <=8 50% • 0.8mg x 2 35 <=8 46% HvH FIAPAC MOSCOW OC.20055

  6. INDUCING EARLY ABORTIONVaginal misoprostol • Study Regimen N Gestational age (wks) Continuing pregnancy • Carbonell et al. (1997) 0.8mgx3+(48h) 175 <=9 8.0% • Carbonell et al. (1999) 0.8mgx3+(24h) 720 <=7 8.3% • 7-8 10.4% • 8-9 13.5% • Carbonell et al. (2001) 1.0mgx3 (24h) 300 6-9 7.0% • Carbonell et al. (2003) 0.8mgx3+ (8h) 450 5-9 9.5% HvH FIAPAC MOSCOW OC.20056

  7. COMPARISON OF TWO ROUTES AND TWO INTERVALS OF MISOPROSTOLFOR TERMINATION OF EARLY PREGNANCY: RANDOMIZED, CONTROLLED MULTICENTRE TRIAL • 11 centres: Armenia, Cuba, Georgia, India, Mongolia and Viet Nam • 2066 women up to 63 days LMP • Three doses of 0.8mg misoprostol • Group I Sublingual, 3-hour interval • Group II Sublingual, 12-hour interval • Group III Vaginal, 3-hour interval • Group IV Vaginal, 12-hour interval HvH FIAPAC MOSCOW OC.20057

  8. Baseline characteristics • Characteristic Sublingual 3h Sublingual 12h Vaginal 3h Vaginal 12h • (n=517) (n=516) (n=516) (n=517) • Age (years) 26.7 5.8 26.7 5.8 26.5 5.7 26.6 5.4 • Nulliparity 221 42.7 201 39.0 212 41.1 206 39.8 • Previous induced abortion • 184 35.6 185 35.9 188 36.4 196 37.9 • Length of pregnancy (days)*, events(%) • 29-49 245 47.4 246 47.7 249 48.3 239 46.2 • 50-56 144 27.9 146 28.3 137 26.6 151 29.2 • 57-63 128 24.8 124 24.0 130 25.2 126 24.4 • * Length of pregnancy assessed by ultrasound HvH FIAPAC MOSCOW OC.20058

  9. Outcomes of treatment by group • Group Outcome No. of Percentages excluding • cases undetermined cases • (95% CI) • Sublingual 3-hour, (n=517) • Complete abortion 431 85.9 (82.5 to 88.8) • Continuing pregnancy 29 5.8 ( 3.9 to 8.2) • Sublingual 12-hour, (n=516) • Complete abortion 399 79.3 (75.5 to 82.8) • Continuing pregnancy 47 9.3 ( 6.9 to 12.2) HvH FIAPAC MOSCOW OC.20059

  10. Outcomes of treatment by group • Group Outcome No. of Percentages excluding • cases undetermined1 cases • (95% CI) • Vaginal 3-hour, (n=516) • Complete abortion 434 87.1 (83.9 to 90.0) • Continuing pregnancy 20 4.0 ( 2.5 to 6.1) • Vaginal 12-hour, (n=517) • Complete abortion 425 85.5 (82.1 to 88.5) • Continuing pregnancy 25 5.0 ( 3.3 to 7.3) HvH FIAPAC MOSCOW OC.200510

  11. Failure to achieve complete abortion* • Treatment group No. of Percentages RR 95% CI Difference 95% CI • failures/no. (%) (%) • of subjects • Sublingual 3-hour 71/502 14.1 1.1 (0.8 to 1.5) 1.3 (-2.9 to 5.5) • Sublingual 12-hour 104/503 20.7 1.6 (1.2 to 2.1) 7.8 (3.2 to 12.4) • Vaginal 3-hour 64/498 12.9 1 (Reference) 0.0 (Reference) • Vaginal 12-hour 72/497 14.5 1.1 (0.8 to 1.5) 1.6 (-2.6 to 5.9) • * Excluding undetermined cases HvH FIAPAC MOSCOW OC.200511

  12. Failure to achieve complete abortion* • Length of pregnancy No. of Percentages RR 95% CI Difference 95% CI • (days)** failures/no. (%) (%) • of subjects • 29-49 132/935 14.1 1 (Reference) 0.0 (Reference) • 50-56 88/571 15.4 1.1 (0.9 to 1.4) 1.3 (-2.4 to 5.0) • 57-63 91/493 18.5 1.3 (1.0 to 1.7) 4.3 (0.2 to 8.4) • * Excluding undetermined cases • ** Length of pregnancy assessed by ultrasound HvH FIAPAC MOSCOW OC.200512

  13. Failure to abort* • Treatment group No. of Percentages RR 95% CI Difference 95% CI • failures/no. (%) (%) • of subjects • Sublingual 3-hour 29/502 5.8 1.4 (0.8 to 2.5) 1.8 (-0.9 to 4.4) • Sublingual 12-hour 47/503 9.3 2.3 (1.4 to 3.9) 5.3 (2.3 to 8.4) • Vaginal 3-hour 20/498 4.0 1.0 (Reference) 0.0 (Reference) • Vaginal 12-hour 25/497 5.0 1.3 (0.7 to 2.2) 1.0 (-1.6 to 3.6) • * Excluding undetermined cases HvH FIAPAC MOSCOW OC.200513

  14. Failure to abort* • Length of pregnancy No. of Percentages RR 95% CI Difference 95% CI • (days)** failures/no. (%) (%) • of subjects • 29-49 44/935 4.7 1 (Reference) 0.0 (Reference) • 50-56 33/571 5.8 1.2 (0.8 to 1.9) 1.1 (-1.3 to 3.4) • 57-63 44/493 8.9 1.9 (1.3 to 2.8) 4.2 (1.4 to 7.1) • * Excluding undetermined cases • ** Length of pregnancy assessed by ultrasound HvH FIAPAC MOSCOW OC.200514

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  20. Side-effects after 0.8 mg misoprostol in two trials (with and without mifepristone pre-treatment) • Side-effectOral/sublingual vaginal • Nausea 31.1 % / 27.0% 22.5% / 25.9% • Vomiting 17.8% / 10.0% 6.9% / 6.3% • Fever 4.7% / 7.6% 4.3% / 5.6% • Pain 71.9% / 79.6% 73.3% / 79.7% • Figures in red = with mifepristone HvH FIAPAC MOSCOW OC.200521

  21. Efficacy of medical abortion in two trials (with and without mifepristone pre-treatment) • Regimen No. Outcome percentages • Mife+O/O 683/740 complete abortion 94.5 • 9/740 continuing pregnancy 1.2 • Mife+V/O 702/741 complete abortion 96.6 • 1/741 continuing pregnancy 0.1 • Mife+V 690/738 complete abortion 95.4 • 2/738 continuing pregnancy 0.3 • Miso V, 3h 434/516 complete abortion 87.1 • 20/516 continuing pregnancy 4.0 HvH FIAPAC MOSCOW OC.200522

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