Thong 1996.
Methods | Sealed, opaque envelopes containing either of the two treatment groups. These envelopes were shuffled and numbered consecutively. | |
Participants | 100 pregnant women (group I: 50, group II: 50) Inclusion criteria: 12‐19 weeks gestation. Exclusion criteria: <16 years. |
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Interventions | All: 200mg mifepristone, 36 hours later: Group I: 1mg pessary gemeprost vaginally in 6 hour intervals, max 4 doses in 24 hour. After 24 hours without abortion 1 mg gemeprost in 3 hour intervals, max 24 hours; Group II: 0.5mg pessary gemeprost vaginally in 6 hour intervals, max 4 doses in 24 h. After 24 hours 1 mg gemeprost in 3 hour intervals. |
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Outcomes | Primary outcome: abortion within 24h. Secondary outcomes: side‐effects. |
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Notes | Definition of abortion: expulsion of fetus and placenta. Evacuation of the uterus was carried out if the placenta was not expelled spontaneously or if it was judged to be incomplete. One woman in group II required a blood transfusion of two units because of heavy bleeding in association with a retained placenta after expulsion of the fetus. |
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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 apparent differences between the groups in terms of maternal age, gestational age and parity. |