USA 2005.
Methods | Randomised, placebo‐controlled. No mention of random‐number generation scheme. Allocation concealment by pharmacy‐assigned numbers to opaque vials containing either misoprostol tablets or oxytocin ampoules. Outcome assessments were blinded. | |
Participants | 352 women undergoing caesarean section in Orlando, Florida, USA. | |
Interventions | Misoprostol 200 mcg buccal vs placebo at cord clamping. All women received 20 IU IV oxytocin in 1000 mL saline. | |
Outcomes | Blood loss, additional uterotonics. Blood loss was estimated following 'standard' procedures. |
|
Notes | No loss to follow‐up. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No mention of random‐number generation scheme. |
Allocation concealment (selection bias) | Low risk | Allocation concealment by pharmacy‐assigned numbers to opaque vials containing either misoprostol tablets or oxytocin ampoules. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "At no time before the data analysis were the assignments available to anyone but the pharmacy." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up was reported. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review have been reported. |
Other bias | Low risk | 2 groups were comparable. |