Hamoda 2005.
Methods | Randomisatin by opening consecutive sealed opaque envelopes generated using random number tables. | |
Participants | 69 pregnant women (group I: 32, group II: 37) Inclusion criteria: singleton intrauterine pregnancy, 13‐20 weeks gestation. Exclusion criteria: < 16 years, severe asthma, haemorrhagic disorders, treatment with anticoagulants, known allergy to prostaglandins, history of cardiac disease, smoking over the age of 35 years with ECG abnormalities, breast feeding. |
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Interventions | All: mifepristone 200mg followed 36‐48 hours later by: Group I: misoprostol 600 μg sublingually and misoprostol 400 μg sublingually every 3h; Group II: misoprostol 800 μg vaginally and misoprostol 400mg μg vaginally every 3h. |
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Outcomes | Primary outcome: induction to abortion interval. Secondary outcomes: acceptability of the route of misoprostol administration to the women and staff, side‐effects. |
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Notes | Definition of abortion: not specified. Surgical evacuation was offered to women if the placenta was not delivered within 1h of delivery of the fetus. Two women suffered from heavy bleeding during the abortion and needed a surgical evacuation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ adequate |
Blinding? All outcomes | High risk | |
Free of other bias? | Low risk | No statistically significant differences between the groups in terms of maternal age, gestational age and parity. |