050 Sahu 2004.
Methods | "The women were randomly allocated". The sequence generation and the allocation concealment were not stated. | |
Participants | Inclusion criteria: singleton pregnancy, vertex presentation, Bishop score < 5 and intact membranes. Exclusion criteria: multiple pregnancy, parity > 4, breech presentation, previous uterine scar, hypersensibility to prostaglandins, probable cephalopelvic disproportion, vaginal bleeding in second pattern and vaginal or cervical infection. |
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Interventions | The intervention group received 50 mcg vaginal misoprostol repeated if no cervical ripening after 6 hours. The comparison group received 0.5 mg intracervical dinoprostone repeated after 12 hours if necessary. Both groups could use oxytocin augmentation. | |
Outcomes | There were no differences between the groups in time interval from induction to delivery, in the incidence of tachysystole, hypersystole and caesarean section rate. The incidence of delivery before 12 hours was higher in the misoprostol group (p < 0.02). | |
Notes | The study was carried from January to April 2002. Rajah Muthaih Medical College and Hospital, Annamalai University, Tamil Nadu. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinded only for personnel |
Incomplete outcome data (attrition bias) All outcomes | High risk | Adequate |
Selective reporting (reporting bias) | Low risk | Adequate |
Other bias | Unclear risk | Unclear |