El‐refaey 1995.
Methods | Randomisation using computer‐generated random number tables. A series of numbered, sealed, opaque envelopes was prepared containing allocation. | |
Participants | 69 pregnant women (group I: 34, group II: 35) Inclusion criteria: 13‐20 weeks gestation. Exclusion criteria: none reported. |
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Interventions | All: mifepristone 600 μg orally + vaginal misoprostol 600 μg (first dose) Group I: oral misoprostol 400 μg every 3 hours, max 5d; Group II: vaginal misoprostol 400 μg every 3 hours, max 5d. If after the fifth dose, abortion had not occurred, 1 mg gemeprost was administered the next morning. |
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Outcomes | Primary outcomes: induction to abortion interval, abortion within 24 hours. Secondary outcomes: side‐effects. |
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Notes | Definition of abortion: abortion occurring after the fifth dose. One patient suffered from rigours, vomiting and eruption of a maculopapular rash following the administration of 600 μg misoprostol. If the placenta was retained, the uterus was surgically evacuated. |
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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. |