Ganguly 2010.
| Methods | Parallel randomised controlled trial. Computer‐generated random number list. The study was conducted at RG Car Medical College and Hospital, Kolkata, India between 1st May 2007 and 30th April 2008. | |
| Participants | Anembryonic gestation or embryonic or fetal death with CRL 5 mm to 40 mm without cardiac activity; inevitable miscarriage with gestational sac < 45 mm or embryonic pole < 40 mm, open cervical os and vaginal bleeding. | |
| Interventions | Intervention: 800 mcg misoprostol vaginally (n = 120). Control: manual vacuum aspiration under iv sedation (n = 60). |
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| Outcomes | Success rate (complete evacuation at day 8); secondary outcomes: adverse events (haemorrhage, cervical tear/perforation, fever, nausea, diarrhoea, abdominal pain, satisfaction (would use this treatment again). | |
| Funding | No information on funding. | |
| Declarations of interest | No information on conflicts of interest. | |
| Notes | Subgroup analyses on fetal death and anembryonic gestation available; therefore the study was included. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: computer‐generated random number list. |
| Allocation concealment (selection bias) | Low risk | Comment: opaque sealed envelope. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: for all 180 patients outcome was presented. |
| Selective reporting (reporting bias) | Unclear risk | Comment: in the results section several outcome measures are presented that were not mentioned in the methods section; unclear whether there were more outcome measures. |
| 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 of participants and personnel. Due to the nature of the intervention blinding would have practically be impossible. However especially the secondary outcomes (experience of pain and satisfaction among the non‐blinded patients) might have been influenced by type of intervention. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Outcome assessors of the study were blinded". |