Gilles 2004.

Methods	Random allocation by computer‐automated telephone response system. Stratification by pregnancy type. Random permuted blocks of size 4 or 8. Participants were recruited from 4 clinical centres between September 2001 and February 2002.
Participants	80 women with anembryonic pregnancy < 46 mm sac diameter or embryonic/fetal death with crown‐rump length < 41 mm. 4 centres.
Interventions	Quote: "Wet misoprostol" 800 mcg + 2 mL saline vaginally (n = 41) vs "dry misoprostol" (as above without saline) (n = 39). Second dose given day 3 if no miscarriage.
Outcomes	Primary outcome: miscarriage without need for curettage before 30 days. Secondary outcomes: miscarriage < 3, < 8 and < 15 days; side effects, women's views.
Funding	Supported by National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services under contracts No. N01‐HD‐1‐3321 through 3325.
Declarations of interest	The following persons and institutions participated in the National Institute for Child Health and Human Development Management of Early Pregnancy Failure Trial (principal investigators are indicated by asterisks): J. Zhang* and T. Nansel (National Institute of Child Health and Human Development); C. Westhoff,* A. Davis, and C. Robilotto (Columbia University); J. Gilles,* J. Kang, F. Doyle, and N. Vazquez (University of Miami); K. Barnhart,* T. Bader, and K. Timbers (University of Pennsylvania); M. Creinin,* B. Harwood, R. Guido, M. Fox, L. Reid (University of Pittsburgh); and M. Frederick,* S. Forman, and X. K. Huang (Clinical Trials and Surveys Corporation). No further information on conflicts of interest.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed with a computer automated telephone response system. The subjects were stratified by pregnancy type with the use of random permuted blocks of size 4 or 8. The Data Coordinating Center developed the process for randomization".
Allocation concealment (selection bias)	Low risk	Quote: "The enrolment sequence was concealed from investigators". Comment: adequate allocation concealment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 2 patients were lost to follow‐up (both in group I) from day 15 (according to table 1); primary outcome was still measured for them before; so for primary outcome there were no incomplete data.
Selective reporting (reporting bias)	Unclear risk	Comment: some outcomes in the results section (for example, abdominal pain) were not mentioned in the methods section. Unclear how many secondary outcomes 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	Quote: "Neither the investigators nor the subjects were masked because the addition of saline solution made the interventions visibly different". Comment: this might have influenced the (perception of) outcome.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: no information on blinding of outcome assessment, considering that investigators and subjects were not masked for the intervention this was probably not done.