Kovavisarach 2005.
| Methods | Random allocation using sealed, sequentially numbered envelopes, prepared using published table of random numbers. Between 25 November 2002 and 31 July 2003, Rajavithi Hospital, Bangkok, Thailand |
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| Participants | 114 women in Bangkok, Thailand, with non‐viable pregnancies (anembryonic or fetal deaths) at < 12 weeks, diagnosed by TVS. Women with open cervices were not eligible for recruitment. | |
| Interventions | Vaginal misoprostol 600 mcg (n = 57) or 800 mcg (n = 57). If complete miscarriage not effected within 24 hours, or if clinical circumstances dictated (pain, bleeding), uterine curettage was performed. | |
| Outcomes | Primary: complete miscarriage without need for uterine curettage within 24 hours. Secondary: 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) | Low risk | Quote: "Women were randomly assigned to either dose of misoprostol using sealed sequentially numbered envelopes that had been prepared using a published table of random numbers". |
| Allocation concealment (selection bias) | Low risk | Quote: "The drugs had been placed in the opaque envelopes by a nurse who was not involved in any of the other study processes". Comment: adequate type of allocation concealment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "No women withdrew from the trial". Comment: no signs of incomplete outcome data. |
| Selective reporting (reporting bias) | Low risk | Comment: no signs of selective reporting, variables that were measured according to the methods section were presented in the results section. |
| Other bias | Low risk | No other source of bias could be detected |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The drugs had been placed in the opaque envelopes by a nurse who was not involved in any of the other study processes. All other staff and patients were blinded to regimen allocation". Group A received 3 tablets of misoprostol and 1 placebo, group B received 4 tablets of misoprostol. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: staff was blinded to regimen allocation. |