Bartley 2002.
Methods | Randomisation was carried out using opaque envelopes. These envelopes were sealed, then shuffled and numbered consecutively in two batches of 50. | |
Participants | 100 pregnant women (group I: 50, group II: 50). Inclusion criteria: gestation 12 to 20 weeks. No exclusion criteria were reported. A history of previous caesarean section was not considered a reason for exclusion. A history of previous caesarean section was not considered a reason for exclusion. |
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Interventions | All: 200 mg mifepristone and admission followed approximately 36 hours later: Group I: 800 μg misoprostol tablets inserted in the posterior vaginal fornix followed by 400 μg misoprostol tablets orally every 3 hours for a maximum of four doses over the first 24 hours; Group II: 1 mg gemeprost inserted in the posterior vaginal fornix every 6 hours for a maximum of four doses over the first 24 hours. If abortion did not occur within 24 hours, 1 mg vaginal gemeprost was administered every 3 hours to a maximum of five doses over the next 12 hours. If abortion did not occur after this course of gemeprost, the abortion was completed by intravenous oxytocin, repeated course of gemeprost or dilatation and evacuation. |
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Outcomes | Primary outcome: prostaglandin to abortion interval. Secondary outcomes: differences in percentage of women delivered by 24 hours, incidence in side effects and adverse events. |
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Notes | No clear definition of abortion. One woman required a blood transfusion and an emergency evacuation of the uterus due to severe haemorrhage. |
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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. |