Shah 2010*.
Methods | This was a prospective randomised open‐labelled trial conducted in the Department of Obstetrics and Gynaecology Unit‐III at Civil Hospital Karachi. No information on study duration. | |
Participants | The inclusion criteria was an ultrasound diagnosis of missed miscarriage < 20 weeks' gestation. | |
Interventions | Intervention: (n = 25) 400 mcg of misoprostol sublingually every 3 hours for a maximum of 5 doses. Patients having a gestational age of more than 12 weeks whose uterine size was also more than 12 weeks were given 200 mcg of misoprostol instead of 400 mcg in both sublingual and vaginal groups. Control: (n = 25) 400 mcg of misoprostol vaginally every 3 hours for a maximum of 5 doses. Patients having a gestational age of more than 12 weeks whose uterine size was also more than 12 weeks were given 200 mcg of misoprostol instead of 400 mcg in both sublingual and vaginal groups. |
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Outcomes | The primary outcome measures were, complete evacuation of POC, mean induction to delivery time and the occurrence of side 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: article states the study was a randomised controlled trial, however there is no information on type of random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation was concealed using sealed envelopes, though depending on the randomness, allocation might have been predictable. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcomes are presented for all 50 patients. |
Selective reporting (reporting bias) | Unclear risk | Comment: there seems to be no loss to follow‐up or incomplete data; outcomes were reported for all 50 patients. Table 3 shows 'side effects' without further specification, unclear which side effects 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: there is no information on blinding in the article. Due to the nature of the interventions (sublingual vs vaginal medication), blinding would be difficult. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcome seems not to be assessed by an independent doctor. |