Shechter‐Maor 2015.
Methods | RCT | |
Participants | Inclusion criteria: singleton, GA 37 weeks or more, cephalic presentation, intact membranes, unfavourable cervix (BS =/< 6), oligohydramnios (AFI =/< 5) Exclusion criteria: multifetal gestation, fetal malpresentation, spontaneous labour, contraindication to PGs or a vaginal delivery (e.g. placenta previa), non‐reassuring FHR tracing, a fetus with major anomalies or previous CS |
|
Interventions | 1. Propess (10 mg slow release PGE), n = 26 2. Double balloon (Cook), n = 26 |
|
Outcomes | Time from induction to active labour (defined as cervical dilation of at least 5 cm), induction to delivery time, CS and operative delivery rates, oxytocin augmentation, uterine tachysystole (defined as greater than 5 uterine contractions in 5 minutes), meconium passage, FHR changes, AS and maternal satisfaction | |
Notes | Setting: Israël Study period: not reported Funding: none received Declarations of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using computer‐generated, random sequences |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | ITT not reported, no missing data described. No figure 1, all women analysed |
Selective reporting (reporting bias) | High risk | All pre‐specified outcomes reported but secondary outcome 'AS' |
Other bias | Unclear risk | Not mentioned in method section how long balloon/dinoprostone was given and what happened after ripening process. |