Makhlouf 2003.
Methods | First 90 patient were randomly assigned into three groups (see notes). Randomisation of the remainig 40 patients involved the group using misoprostol and glyceryl trinitrate only, because of shortage of finance to buy more prostaglandin tablets. Randomisation involved computer‐generated random tables. | |
Participants | 80 pregnant women (group I: 50, group II: 30) Inclusion criteria: 13‐28 weeks gestation, Bishop score ≤ 4. Exclusion criteria: contra‐indication to induction of abortion by medical methods, e.g. placenta previa, preterm rupture of membranes (PROM) and transverse lie, grand‐multiparous women (parity ≥ 5), previous scarred uterus or contra‐indications to the drugs. |
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Interventions | Group I: 100 μg misoprostol, vaginally every 4 hours, with a maximum dose of 500 μg (five doses). Group II: 6 mg prostaglandin E2 , vaginally every 6 hours, with a maximum of 24 mg (four doses). Women with a method failure and a Bishop score ≤ 4 or absence of uterine activity continued abortion by using a Foley's catheter. If uterine contractions started or the Bishop score was > 4, but expulsion did not occur after 24 hours of after expulsion of the Foley catheter, intravenous 5mIU/min of oxytocin infusion was used. We excluded the outcome 'induction to abortion interval' because of this method after 24 hour. |
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Outcomes | Induction to abortion interval, abortion within 24 hours, side‐effects. | |
Notes | Definition of method failure: absence of fetal expulsion of absence of signs of impending expulsion (regular uterine contractions and cervical dilatation) at the end of 24 hours. No clear information was provided regarding the policy of evacuation of the uterus. No major complications described. Study included 130 pregnant women into three groups. The third group (n = 50) were randomised for the use of nitric oxide donor (glyceryl trinitrate) tablets. Women received 500 μg of glyceryl trimitrate evert 6h, with a maximum of 5 doses. For this review, this group was excluded. |
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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. |