Author(s): VB per corso SaPeRiDoc Date: 2009-10-01
Question: Should oral misoprostol (600 mcg) vs im ossitocina (10 UI) be used for prevenzione PPH?
Settings: ospedaliero - terzo stadio del travaglio di parto
Bibliography: (GA 06) Gulmezoglu AM, Forna F, Villar J, Hofmeyr GJ. Prostaglandins for prevention of postpartum haemorrhage. Cochrane Database Syst Rev. updated 21.07.06
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lo studio WHO 01 ha avuto una perdita post randomizzazione di 50/9264 donne in misoprostol group e 38/9226 donne in oxytocin group
2solo 1 trial (WHO 01)
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WHO 01 includes only low risk women (exclusion criteria: pyrexia > 38° C on admission to labour ward, severe asthma, bleeding disorders, elective caesarean section)
Quality assessment Summary of findings
Importance
No of patients Effect
Quality No of
studies Design Limitations Inconsistency Indirectness Imprecision Other considerations
oral misoprostol
(600 mcg)
im ossitocina
(10 UI)
Relative
(95% CI) Absolute morti materne
1 randomised trial
very serious
1no serious inconsistency
2serious
3no serious imprecision
none
2/9264
2/9266
RR 1 (0 to 0.1)
0 fewer per 1000 (from 0
fewer to 0 fewer)
⊕ΟΟΟ VERY LOW
0% 0 fewer per
1,000 perdita ematica uguale o superiore a1000 ml
7 randomised
trial serious
4no serious inconsistency
5serious
6no serious imprecision
none
410/11360
307/11389
RR 1.34 (1.16 to
1.55)
9 more per 1000 (from 4
more to 15
more) ⊕⊕ΟΟ
4.3% 14 more per LOW
1,000
14.8% 50 more per
1,000 ricorso a uterotonici addizionali
5 randomised
trial serious
7no serious inconsistency
5serious
8no serious imprecision
none
1691/10791
1205/10800
RR 1.40 (1.31 to
1.5)
45 more per 1000 (from 35 more to
56 more) ⊕⊕ΟΟ
4.4% 17 more per LOW
1,000
14.% 55 more per
1,000
08.2.10 GRADE
Page 1 of 2
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WHO 01 post randomization withdrawal in 50/9264 women in misoprostol group and in 38/9226 women in oxytocin group. Hong Kong 01 outcome assessments were not blinded. Blood loss estimated and not measured in Belgium 99, Hong Kong 01, Nigeria 03, Turkey 03
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Significant results coming from a single large study (WHO 01)
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All studies include only low risk women (excluding women with pre-existing diseases and or women at risk for hemorrhage). Four out of seven studies use drugs or doses other than the one considered in the question: a.Belgium 99 compares misoprostol 600 mcg orally versus methylergometrine 200 mcg IV b.France 01 compares
Misoprostol 600 mcg orally vs oxytocin 2.5 IU intravenously given after cord clamp, vs no uterotonic c.Hong Kong 01 compares Misoprostol 600 mcg oral after delivery of the baby, vs oxytocin 5 IU + ergometrine 0.5 mg IM at delivery of anterior shoulder. d.Turkey 03 compares 4 groups, all received corresponding placebos. Group 1:
oxytocin 10 IU IV plus misoprostol 400 mcg orally after cord clamp, followed by 2 doses 4 and 8 hours after delivery of 100 mcg misoprostol. Group 2: misoprostol 400 mcg orally after cord clamp followed by 2 doses 4 hours apart of 100 mcg misoprostol. Group 3: oxytocin 10 IU IV. Group 4: oxytocin 10 IU IV plus 1 ml methylergometrine IM.e.
WH 99 e. WHO 99, WHO 01and Ni 03 compare Misoprostol vs. Oxytocin 10UI im f. Be 99, Fr 01, Ho 01 e Tu 07 compare Misoprostol vs. uterotonics other than oxytocin 10 UI im
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WHO 01 post randomization withdrawal in 50/9264 women in misoprostol group and in 38/9226 women in oxytocin group India 05 allocation concealment not clear, random allocation with no further details Hong Kong 01 outcome assessments were not blinded India 05 no mention of missing data or loss to follow-up.
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