Tey 1995.
| Study characteristics | ||
| Methods | Randomised controlled trial carried out in the USA. | |
| Participants | 40 women at 37 to 42 weeks, with an ultrasound estimated fetal weight between 4000 g and 4750 g. | |
| Interventions | Induction of labour was performed with PGE2 gel if the cervical status was unfavourable (Bishop score < 6), followed by oxytocin infusion. | |
| Outcomes | Mean birthweight, caesarean section and shoulder dystocia. | |
| Notes | Additional information kindly provided by the authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated table of random numbers. |
| Allocation concealment (selection bias) | Low risk | Sealed opaque, consecutively‐numbered envelopes, prepared by an individual not involved in the study. Envelopes were opened only after inclusion of women. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not feasible to blind women or clinical staff to treatment allocation and lack of blinding may have affected clinical management and outcomes. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported; it was likely that outcome assessment was not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not clear ‐ only published as an abstract. |
| Selective reporting (reporting bias) | Unclear risk | Not clear ‐ only published as an abstract. |
| Other bias | Unclear risk | Not clear ‐ only published as an abstract. |
CPAP: continuous positive airways pressure NICU: neonatal intensive care unit PGE2: prostaglandins E2 PPH: postpartum haemorrhage PROM: premature rupture of membranes