Nielsen 1999.
| Methods | Randomisation method not discussed in paper. Sahlgrenska University Hospital, Sweden. No information on study duration. |
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| Participants | 122 women < 13 weeks with symptoms of threatened miscarriage (bleeding +/‐ pain), a closed cervix, and ultrasound demonstration of pregnancy non‐viability (anembryonic pregnancy n = 44; embryonic/fetal death n = 46; 'complex mass with deformed gestational sac' n = 32). Surgical evacuation at day 5 if transvaginal ultrasound showed retained products > 15 mm diameter. | |
| Interventions | Mifepristone (400 mg orally) followed by oral misoprostol (400 mcg) 48 hours later (n = 60) vs expectant management (n = 62). | |
| Outcomes | Clinical events; routine transvaginal ultrasound at 5 days to identify retained products; visual analogue scale to assess pain at day 5; visual analogue scale to assess satisfaction at day 14. | |
| Funding | No information on funding. | |
| Declarations of interest | No information on conflicts of interest. | |
| Notes | Seeking clarification from authors if "complex mass with deformed gestational sac" represents missed or incomplete miscarriage. Data included in meantime. | |
| 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 | Low risk | Comment: no loss to follow‐up, no signs of missing data. |
| Selective reporting (reporting bias) | Low risk | Comment: no signs of selective reporting. |
| Other bias | Low risk | No other source of bias could be detected |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: article does not state that in the expectant management group placebo were used. Therefore there probably was no blinding of participants and personnel. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessment, probably not done. |