Wing 2004.
Methods | Sequentially‐numbered, sealed envelopes. | |
Participants | 200 women at any gestation with favourable cervices (BS > 6) and intact or recently ruptured membranes (less than 24 hours). | |
Interventions | Oral misoprostol 100 mcg 4‐hourly (max x 6) or iv oxytocin infusion ("standard regimen"). | |
Outcomes | Labour and delivery outcomes. Neonatal outcomes. | |
Notes | 2 women in misoprostol group accidentally received extra‐amniotic saline. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Treatment allocation was determined with the use of a computer generated random number table. |
Allocation concealment (selection bias) | Low risk | Sequentially‐numbered, sealed envelopes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only two women were excluded from analysis because of deviation from study protocol. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’ |
Other bias | Unclear risk | Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’ |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The study was not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The study was not blinded. |
ARM: artificial rupture of membranes BS: Bishop score CS: caesarean section CTG: cardiotocography FHR: fetal heart rate hr(s): hour(s) IUGR: intrauterine growth restriction iv: intravenous max: maximum mcg: micrograms mU/min: milliunits per minute mU/mL: milliunits per millilitre mec: meconium mg: milligram NICU: Neonatal intensive care unit PGE2: prostaglandin cream po: oral administration ('per oram') PROM: premature rupture of membranes pv: vaginal administration ('per vaginum') SD: standard deviation SROM: spontaneous rupture of membranes vs: versus