Bebbington 2002.
Methods | Randomization was performed with a series of sequentially numbered opaque envelopes that contained allocations determined through the use of a random number table. | |
Participants | 114 pregnant women (group I: 49, group II: 65) Inclusion criteria: midtrimester abortion. Exclusion criteria: hypersensitivity to prostaglandins, inability to understand English to ensure informed consent. |
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Interventions | Group I: misoprostol 400 μg in the posterior vaginal fornix every 4 hours. Group II: misoprostol 200 μg orally every hour for 3 hours and then 400 μg orally every 4 hours. If the patient was undelivered after 24 hours, the attending physician determined further management. The options available were to increase the dosage of misoprostol using the same route of administration, to change the route of administration of the misoprostol, to proceed with a high‐dose oxytocin infusion, or to proceed with surgical evacuation of the uterus. |
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Outcomes | Primairy outcomes: induction to abortion interval. Secondary outcomes: maternal fever >38°C; maternal infection defined as maternal fever, elevated white blood cell count, and the need for antibiotics in the postabortion period; maternal side effects from the medication including nausea or diarrhoea, blood loss, the need for additional operative intervention; and the failure to achieve a medical termination of pregnancy. |
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Notes | Definition of abortion: expulsion of the fetus. If the placenta remained undelivered after 2h, an attempt was made at manual extraction under general anaesthesia. No major complications reported. |
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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. |