Petersen 2013.

Methods	This was a parallel group randomised controlled study performed between September 2005 and July 2010 at 2 hospitals in Australia. Randomisation was performed using a computer‐generated model with a block size of 6 stratified for study site.
Participants	Inclusion criteria Clinically confirmed early pregnancy loss 6 + 0 and 12 + 6 weeks’ gestation. Haemodynamically stable and not requiring emergency treatment. Willingness and consenting to undergo medical management. Ready access to emergency medical care (lives within 30 minutes of hospital). Immediate availability of another responsible adult with a driver's license. Ability to understand spoken English instructions without the need of a translator.
Interventions	Intervention: 400 mcg (n = 158) vaginal misoprostol; if needed repeated the next day vs 800 mcg (n = 152) vaginal misoprostol; if needed repeated the next day.
Outcomes	Outcomes: the primary outcome was the effectiveness to induce complete miscarriage, evaluated using 2 different methods. 1 Ultrasound criteria: complete = no gestational sac + an endometrial thickness < 30 mm on day 7 scan; incomplete = gestational sac or endometrial thickness > 30 mm3. 2 Clinical criteria: resolution of bleeding and pain, and return to a normal menstrual cycle, without the need for D&C at the completion of follow‐up. Secondary outcomes included patient satisfaction and clinical outcomes – need for second dose; patient‐reported side effects recorded in Study Questionnaire 1; adverse events; unplanned visits to a doctor or hospital Emergency Department; fall in haemoglobin from baseline.
Funding	Completion of this study was supported in part by a grant from the Toowoomba Hospital Foundation.
Declarations of interest	The authors have nothing to declare.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: randomisation was performed using a computer‐generated model with a block size of 6 stratified for study site.
Allocation concealment (selection bias)	Low risk	Comment: allocation to the study groups was made by opening the next consecutively numbered, sealed.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: data on incomplete follow‐up are provided in figure 2 (participation flow chart).
Selective reporting (reporting bias)	Unclear risk	Comment: methods section states that adverse events were measured without further specification. It is unclear if the outcomes mentioned in table 3 were all that 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: the allocated dose was recorded in the medication chart and administered by the non blinded attending staff. The allocated dose was not revealed to the study population (although they would probably notice the difference between 2 or 4 tablets).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: the allocated dose was recorded in the medication chart and administered by the non‐blinded attending staff. This attending staff seems to also have performed the ultrasounds after treatment.