Armatage 1996.
Methods | Patients were randomised into 2 groups using sealed sequentially numbered envelopes. | |
Participants | 99 pregnant women (group I: 50, group II: 49) Inclusion criteria: uncomplicated pregnancies, between 12‐20 weeks gestation. Exclusion criteria: multiple pregnancy, known fetal abnormality, significant maternal illness. |
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Interventions | Group I: gemeprost pessaries at 3‐hourly intervals up to a maximum of 5 in 24 hours, until fetal expulsion. Group II: gemeprost pessaries at 6‐hourly intervals until fetal expulsion. Where abortion did not occur within 48 hours, an intravenous oxytocin infusion was commenced unless delivery was deemed imminent. |
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Outcomes | Primary outcome: abortion interval, abortion rates. Secondary outcomes: analgesia, side‐effects, surgical evacuations. |
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Notes | Definition of abortion: expulsion of the fetus. Following delivery of the fetus, intramuscular Syntometrine (ergometrine maleate 500 μg and oxytocin 5 iu, Sandez Products Limited) was given. One women received a blood transfusion (group 1). Women underwent surgical evacuation if the placenta was retained or did not appear intact. |
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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. |