Methods	RCT, no details regarding method of random assignment.
Participants	144 ‘healthy’ women having their first baby booked for delivery at a Swedish hospital (72 to doula group and 72 to usual care). Participants were enrolled at 36 weeks’ gestation
Interventions	Continuous presence by a doula who had met the woman during pregnancy, compared to usual care
Outcomes	Emergency caesarean birth and epidural analgesia.
Notes	The trial author reported that the information about randomisation method and outcomes of those lost to follow-up are no longer available Epidural analgesia was available. It was not stated if other support person(s) were allowed or if EFM was used routinely
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	‘Randomized’ - no further details provided or available.
Allocation concealment (selection bias)	Unclear risk	No details provided or obtained.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not noted.
Incomplete outcome data (attrition bias) All outcomes	High risk	Medical record data collected on 70.1% of sample. No usable outcome data, due to serious risk of attrition bias. Outcomes are reported for 55/72 (76%) of the intervention group and 46/72 (64%) of the control group. Reason for the 41 “dropouts” were preterm birth, induction, or caesarean section “for medical reasons”, and participant withdrawal. No numbers are given for individual reasons, or by group, but it is clear that some “dropouts” were prior to labour and others were during labour. Numbers in the report show the number of dropouts was actually 43
Selective reporting (reporting bias)	Unclear risk	Sample size was based on caesarean section rate. The only outcome reported was emergency caesarean
Other bias	High risk	Trial was stopped early for ‘a range of largely organizational issues’ when only 1/4 of the original sample size had been enrolled