Eng 1997*.
| Methods | Randomised by quote: "blindly picking a sealed number from a box". Treatment allocation was then based on whether the number was odd or even. Hospital Kuala Lumpur Malaysia; June 1995 to January 1996 | |
| Participants | 50 women with IUFD at 13‐26 weeks of pregnancy. | |
| Interventions | Vaginal misoprostol 200 mcg 3‐hourly up to a maximum dose of 1200 mcg (n = 25) vs vaginal gemeprost 1 mg 3‐hourly up to a maximum dose of 5 mg (n = 25). | |
| Outcomes | Main outcome quote: "treatment failure" defined as failure to miscarry within 24 hours, or side effects severe enough to preclude use of additional dose of drug. | |
| Funding | No information on funding. | |
| Declarations of interest | No information on conflicts of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Randomization was carried out by blindly picking a sealed number from a box. Odd numbers were assigned to group A (misoprostol) and even numbers to group B (gemeprost)". Comment: no information on who put the numbers in the box. |
| Allocation concealment (selection bias) | Unclear risk | Comment: inadequate allocation concealment; a sealed number was picked from a box; not clear if the investigators used opaque envelopes, not clear who put the numbers in the box. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: it seems that all 50 patients completed the study. |
| Selective reporting (reporting bias) | Unclear risk | Comment: the methods section states that 'side effects' were measured, without further specification. It is unclear whether the side effects that are mentioned in the results section were all that were measured. |
| Other bias | Low risk | No other source of bias could be detected |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no information on blinding participants and personnel, probably not done. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessment, probably not done. |