Moini 2003.
Methods | RCT: quote: "randomly assigned". | |
Participants | Singleton gestation, cephalic presentation, GA between 37 and 42 weeks, BS < 6. Exclusion: malpresentation, ruptured membranes, active genial herpes, antepartum bleeding, fetal death, cephalopelvic disproportion, indication for emergency termination of pregnancy, history of infertility or CS, women who had undergone induction before presenting. |
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Interventions | Dinoprostone intracervical 0.5 mg, oxytocin infusion after 6 hours (n = 35). Foley catheter 30 mL + EASI (n = 35). |
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Outcomes | Change in BS (after 6 hours), induction‐delivery interval, need for oxytocin, mode of delivery, fetal complications, maternal complications. | |
Notes | No sample size calculation. Setting: Roointan‐Arash Maternity Hospital, Iran Dates of study: April 2000 ‐ April 2001 Funding sources: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about sequence generation process quote: "randomly assigned". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not mentioned. |
Selective reporting (reporting bias) | Unclear risk | All pre‐specified outcomes are reported, it is however unclear what is meant by 'fetal complications', and it is likely that there were more outcomes noted. |
Other bias | Low risk | No other bias detected |