Miras 2014

Methods	A prospective, longitudinal, observational study. Women were randomly selected into 2 groups. The study was performed double blind.
Participants	300 women attending Eusebio Hernandez Teaching Hospital in Havana from 1 January 2011 to 1 September 2012 Criteria for inclusion and exclusion were clear (detailed in France)
Interventions	Mife 10 mg vs Mife 5 mg, both single dose, orally
Outcomes	Observed number of pregnancies
Notes	Post‐randomisation exclusions or loss to follow‐up not reported Observed pregnancy/total number of women: Mife 5 mg 2/150 ; Mife 10 mg 2/150
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Finally, a sample of 300 women was chosen by simple random sampling without replacement"‐ doesn't elaborate on method. Also claims to be a longitudinal, observational study but also randomised
Allocation concealment (selection bias)	Unclear risk	Doesn't explain allocation concealment method
Blinding (performance bias and detection bias) All outcomes	Unclear risk	States that it is double‐blinded but doesn't elaborate how/who
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Doesn't appear to refer to loss to follow‐up etc
Selective reporting (reporting bias)	Unclear risk	Doesn't state planned outcomes in methods to check in results
Other bias	Unclear risk	Hard to assess as paper is in Spanish