Ngai 2000.
Methods | Randomisation schedule as described by Meinert. Sealed envelopes with serial numbers were prepared. At enrolment, a serial number was given according to the sequence of entry. | |
Participants | 139 pregnant women (group I: 70, group II: 69) Inclusion criteria: healthy women between 16‐35 years, 14‐20 weeks gestation. Exclusion criteria: regular use of prescription drugs, IUD in utero, nursing mothers, multiple pregnancies, heavy smokers. |
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Interventions | All: 200mg mifepristone + (36 ‐ 48 h later): Group I: 400 μg misoprostol oral and a vaginal placebo (vitamin B6) every 3 hours; Group II: 200 μg misoprostol vaginally and an oral placebo (vitamin B6) every 3 hours. |
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Outcomes | Primary outcome: abortion within 24 hours. Secondary outcomes: induction to abortion interval, side‐effects. |
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Notes | Definition of abortion: not specified. If the placenta was incomplete, an evacuation of the uterus was carried out under general anaesthesia. No major complications occurred. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ adequate |
Blinding? All outcomes | Low risk | Blinding for participants. |
Free of other bias? | Unclear risk | No statistically significant differences between the groups in terms of maternal age and gestational age. |