Niromanesh 2005*.
Methods | Randomisation method not discussed in paper. Mirza Khochak khan Hospital, Tehran, Iran. No information on study duration. |
|
Participants | 100 women in Tehran, Iran, with fetal deaths between 14 and 25 weeks. | |
Interventions | Vaginal misoprostol: 400 mcg (n = 50) vs 600 mcg (n = 50) ‐ both 12‐hourly for 48 hours. | |
Outcomes | Miscarriage; surgical evacuation; adverse effects. | |
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) | Unclear risk | Comment: randomisation method not discussed in paper. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no information on loss to follow up, number of eligible patients, etcetera. |
Selective reporting (reporting bias) | Unclear risk | Comment: side effects mentioned in the results (table 2) were not mentioned in the methods section; unclear if these were all outcomes 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, also no statements on use of placebo. Probaby no blinding (since the difference between 2 or 3 tablets would be clear for both patients as well as personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessment, probably not done. |