Akoury 2004.
Methods | Computer‐generated randomisation sequence with stratification for participating centre and gestational age (≥20 weeks versus < 20 weeks) using blocks of 6. A central office allocated study patients to groups using sealed opaque envelopes. Women were randomly assigned. | |
Participants | 136 pregnant women (group I: 84, group II: 52) Inclusion criteria: singleton, live fetus at 15 to 24 weeks’ gestation with a complex fetal anomaly and/or abnormal fetal karyotype were included. Exclusion criteria: allergy to prostaglandins, a previous classic cesarean section or hysterotomy, active bleeding, severe asthma, severe oligohydramnios, pre‐labor rupture of membranes. |
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Interventions | Group I: 400 mg of misoprostol in the posterior fornix of the vagina every 4 hours for a total of 6 doses or until delivery occurred. If after 24 hours no labor commenced, an intravenous solution of oxytocin, 100 U/of L Ringer’s lactate at 100 mL per hour, was commenced. Group II: 400 μg misoprostol orally every 4 hours for a total of 6 doses or until delivery occurred. If after 24 hours no labor commenced, an intravenous solution of oxytocin, 100 U/of L Ringer’s lactate at 100 mL per hour, was commenced. |
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Outcomes | Primary outcome: time from the start of the procedure to placental delivery. Secondary outcomes: incidence of major and minor maternal complications, women’s views of the method and the success rate for culture of fetal umbilical cord. |
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Notes | In this study, women were randomly assigned to 1 of 3 groups: intra‐amniotic PGF2a, vaginal misoprostol, or oral misoprostol. (n=217). The women receiving PGF2a were excluded from our analyses, because of the use of laminaria. Definition of abortion: expulsion of the fetus and placenta. No clear information was provided regarding the policy of evacuation of the uterus. 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 | High risk | |
Free of other bias? | Low risk | No statistically significant differences between the groups in terms of maternal age, gestational age and parity. |