MISOPROSTOL-ONLY REGIMENS FOR MEDICAL ABORTION Department of Reproductive Health and Research World...
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Transcript of MISOPROSTOL-ONLY REGIMENS FOR MEDICAL ABORTION Department of Reproductive Health and Research World...
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MISOPROSTOL-ONLY REGIMENSFOR MEDICAL ABORTIONDepartment of Reproductive Health and ResearchWorld Health OrganizationGeneva
HELENA VON HERTZEN
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *MISOPROSTOLSynthetic analogue of naturally occurring prostaglandin E1Approved in >80 countries (prevention and treatment of gastric and duodenal ulcers; Brazil, Egypt, France also other indications)Safe and well toleratedTablets can be kept at room temperature when packed in aluminium blisters
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Mean plasma concentrations of misoprostol acid over time with oral and vaginal administration
HvH FIAPAC MOSCOW OC.2005 *
PVL_PCC-02_EC/*
vaginal administration
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=
Oral administration
(Zieman, 1997)
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HvH FIAPAC MOSCOW OC.2005 *
HvH FIAPAC MOSCOW OC.2005 *
Diagr1
024.53.333333333340
58.333333333384.274.833333333393.5
183.1666666667135.2124.3333333333124.6666666667
133.288.6132234.6666666667
184.5105.3178.5355.3333333333
27389255374.8
245.2122.3333333333278.8333333333342.6
364135.2222222222348.3333333333210
453.6666666667165.5555555556240240
vaginal
oral
sulingual 0.2mg
sulingual 0.4mg
Min
Montevideo Units
Blad1
MONTEVIDEO
min0306090120150180210240
CYTOTECMONTEVIDEOVAGINALTSE means
mean058.3183.2133.2184.5273.0245.2364.0453.7
SD0106.6181.175.084.6101.2145.0205.7230.9
n555555555
SE047.781.033.637.845.364.892.0103.263.2
CYTOTECMONTEVIDEOORALT
mean24.584.2135.288.6105.389.0122.3135.2165.6
SD31.575.296.985.7129.562.9108.8112.4168.3
n10.010.010.010.010.010.010.010.010.0
SE10.023.830.627.141.019.934.435.553.233.2
CYTOTECMONTEVIDEOSUBLINGUALT0.2 MG
mean3.374.8124.3132.0178.5255.0278.8348.3
SD2.6110.8118.6105.8186.0245.1198.6243.4
n6.06.06.06.06.06.06.06.0
SE1.145.248.443.276.0100.081.199.470.5
CYTOTECMONTEVIDEOSUBLINGUALT0.4 MG
mean40.093.5124.7234.7355.3374.8342.6321.8
SD56.180.482.4187.7279.8344.4333.5241.3
n66666666
SE22.932.833.676.6114.2140.6136.198.590.4
minmeansmeansmeansmeans
VAGINALORALSUBL 0.2SUBL 0.4
024.53.340.0
3058.384.274.893.5
60183.2135.2124.3124.7
90133.288.6132.0234.7
120184.5105.3178.5355.3
150273.089.0255.0374.8
180245.2122.3278.8342.6
210364.0135.2348.3321.8
240453.7165.6
TONUS
min0306090120150180210240
CYTOTECTONUSVAGINALTSE means
mean13.620.140.340.436.638.740.945.046.3
SD3.76.114.711.29.18.610.08.89.7
n999999999
SE1.22.04.93.73.02.93.32.93.23.3
CYTOTECTONUSORALT
mean12.041.350.435.730.431.036.340.234.8
SD8.012.18.912.410.210.611.813.315.1
n101010101010101010
SE2.53.82.83.93.23.43.74.24.83.7
CYTOTECTONUSSUBLINGUALT0.2 MG
mean17.533.753.041.537.737.541.542.5
SD9.513.89.97.99.811.810.19.9
n66666666
SE3.95.64.03.24.04.84.14.04.3
CYTOTECTONUSSUBLINGUALT0.4 MG
mean13.430.855.858.450.651.853.655.0
SD1.912.78.88.416.720.022.322.3
n66666666
SE0.85.23.63.46.88.29.19.16.5
minmeansmeansmeansmeans
VAGINALORALSUBL 0.2SUBL 0.4
013.612.017.513.4
3020.141.333.730.8
6040.350.453.055.8
9040.435.741.558.4
12036.630.437.750.6
15038.731.037.551.8
18040.936.341.553.6
21045.040.242.555.0
24046.334.8
Blad2
0306090120150180210240
vaginal13.620.140.340.436.638.740.94546.3
oral24.584.2135.288.6105.389122.3135.2165.6
sulingual 0.2mg3.374.8124.3132178.5255278.8348.3
sulingual 0.4mg4093.5124.7234.7355.3374.8342.6321.8
Blad2
0000
0000
0000
0000
0000
0000
0000
0000
0000
vaginal
oral
sulingual 0.2mg
sulingual 0.4mg
MIN
TONUS
Blad3
0306090120150180210240
vaginal058.3183.2133.2184.5273.0245.2364.0453.7
oral24.584.2135.288.6105.389.0122.3135.2165.6
sulingual 0.2mg3.374.8124.3132.0178.5255.0278.8348.3
sulingual 0.4mg40.093.5124.7234.7355.3374.8342.6
Blad3
0000
0000
0000
0000
0000
0000
0000
0000
0000
vaginal
oral
sulingual 0.2mg
sulingual 0.4mg
MIN
MONTEVIDEO UNITS
- HvH FIAPAC MOSCOW OC.2005 *INDUCING EARLY ABORTIONOral misoprostolStudyRegimen N Gestational Success age (wks) Rabe et al.(1987) 0.4mg x 2 100 9 -1211% 0.2mg x 2 100 9 -12 9% Norman et al.(1991) 0.2mg 0.6mg 40
- HvH FIAPAC MOSCOW OC.2005 *INDUCING EARLY ABORTIONVaginal misoprostolStudyRegimenN Gestational age (wks) Continuing pregnancy Carbonell et al. (1997)0.8mgx3+(48h) 175
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HvH FIAPAC MOSCOW OC.2005 *COMPARISON OF TWO ROUTES AND TWO INTERVALS OF MISOPROSTOLFOR TERMINATION OF EARLY PREGNANCY: RANDOMIZED, CONTROLLED MULTICENTRE TRIAL11 centres: Armenia, Cuba, Georgia, India, Mongolia and Viet Nam2066 women up to 63 days LMPThree doses of 0.8mg misoprostol
Group ISublingual, 3-hour intervalGroup IISublingual, 12-hour intervalGroup IIIVaginal, 3-hour intervalGroup IVVaginal, 12-hour interval
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Baseline characteristicsCharacteristicSublingual 3hSublingual 12hVaginal 3h Vaginal 12h (n=517) (n=516) (n=516) (n=517) Age (years)26.7 5.8 26.7 5.8 26.5 5.726.6 5.4Nulliparity22142.720139.021241.120639.8Previous induced abortion18435.618535.918836.419637.9Length of pregnancy (days)*, events(%) 29-4924547.424647.724948.323946.2 50-5614427.914628.313726.615129.2 57-6312824.812424.013025.212624.4 * Length of pregnancy assessed by ultrasound
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Outcomes of treatment by groupGroupOutcomeNo. ofPercentages excludingcasesundetermined cases (95% CI)
Sublingual 3-hour, (n=517)Complete abortion 43185.9 (82.5 to 88.8)Continuing pregnancy 29 5.8 ( 3.9 to 8.2)Sublingual 12-hour, (n=516)Complete abortion 39979.3 (75.5 to 82.8)Continuing pregnancy 47 9.3 ( 6.9 to 12.2)
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Outcomes of treatment by groupGroupOutcomeNo. ofPercentages excludingcasesundetermined1 cases (95% CI)
Vaginal 3-hour, (n=516)Complete abortion 43487.1 (83.9 to 90.0)Continuing pregnancy 20 4.0 ( 2.5 to 6.1)Vaginal 12-hour, (n=517)Complete abortion 42585.5 (82.1 to 88.5)Continuing pregnancy 25 5.0 ( 3.3 to 7.3)
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Failure to achieve complete abortion*Treatment groupNo. ofPercentagesRR 95% CIDifference 95% CIfailures/no. (%) (%)of subjects
Sublingual 3-hour71/50214.11.1(0.8 to 1.5) 1.3(-2.9 to 5.5)
Sublingual 12-hour 104/50320.71.6(1.2 to 2.1)7.8(3.2 to 12.4)
Vaginal 3-hour64/49812.9 1(Reference)0.0(Reference)
Vaginal 12-hour 72/49714.51.1(0.8 to 1.5)1.6(-2.6 to 5.9)
* Excluding undetermined cases
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Failure to achieve complete abortion*Length of pregnancyNo. ofPercentagesRR 95% CIDifference 95% CI (days)**failures/no. (%) (%)of subjects
29-49 132/93514.11(Reference) 0.0(Reference)
50-56 88/57115.41.1(0.9 to 1.4) 1.3(-2.4 to 5.0)
57-63 91/49318.51.3 (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.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Failure to abort*Treatment groupNo. ofPercentagesRR 95% CIDifference 95% CIfailures/no. (%) (%)of subjects
Sublingual 3-hour29/502 5.81.4(0.8 to 2.5) 1.8(-0.9 to 4.4)
Sublingual 12-hour 47/503 9.32.3(1.4 to 3.9)5.3 (2.3 to 8.4)
Vaginal 3-hour20/4984.01.0(Reference)0.0(Reference)
Vaginal 12-hour25/4975.01.3 (0.7 to 2.2)1.0(-1.6 to 3.6)
* Excluding undetermined cases
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Failure to abort*Length of pregnancyNo. ofPercentagesRR 95% CIDifference 95% CI (days)**failures/no. (%) (%)of subjects
29-49 44/9354.7 1(Reference) 0.0(Reference)
50-56 33/5715.81.2 (0.8 to 1.9) 1.1(-1.3 to 3.4)
57-63 44/4938.91.9 (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.2005 *
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HvH FIAPAC MOSCOW OC.2005 *
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *
HvH FIAPAC MOSCOW OC.2005 *
-
HvH FIAPAC MOSCOW OC.2005 *
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Side-effects after 0.8 mg misoprostol in two trials (with and without mifepristone pre-treatment) Side-effectOral/sublingual vaginal Nausea31.1 % / 27.0% 22.5% / 25.9%Vomiting17.8% / 10.0% 6.9% / 6.3%Fever 4.7% / 7.6% 4.3% / 5.6%Pain71.9% / 79.6% 73.3% / 79.7%
Figures in red = with mifepristone
HvH FIAPAC MOSCOW OC.2005 *
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HvH FIAPAC MOSCOW OC.2005 *Efficacy of medical abortion in two trials (with and without mifepristone pre-treatment) RegimenNo. 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.2005 *