Herabutya 1997.
Methods | Quote: "Random allocation" but method not discussed in paper. Ramathibodi Hospital between March 1995 and April 1996, Bangkok, Thailand. |
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Participants | 84 women with ultrasound confirmation of fetal death with uterine size < 14 weeks, no bleeding, and cervix closed. | |
Interventions | Misoprostol (200 mcg vaginally) (n = 42) or vaginal placebo (n = 42) on admission to hospital. | |
Outcomes | Primary outcome was miscarriage within 24 hours of treatment. Some information available on complications. | |
Funding | No information on funding. | |
Declarations of interest | No information on conflicts of interest. | |
Notes | Much of the outcome data reported describes only the subgroups who did miscarry before surgical evacuation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information on random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: for all 84 randomised patients outcome was presented. |
Selective reporting (reporting bias) | High risk | Comment: The methods section states that side effects were registered, but they were not reported in the results. Much of the outcome data reported describes only the subgroups who did miscarry before surgical evacuation. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information on blinding of patients and personnel. Sinces patients received either misoprostol or placebo it is likely that they were blinded, but this is not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: there is no information on blinding of outcome assessment. Considering that placebo was used as comparison there might have been blinding of the outcome assessor, assuming this was not the person providing the medication (and thus capable of recognising a placebo if it had another shape than the misoprostol). |