Thomassen 2003.
| 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 Dates of study: March 1998 ‐ March 2000 Funding: not reported in translation. Conflicts of interest: not reported in translation. |
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| 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 of participants and personnel (performance bias) All outcomes | High risk | Participants and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome data were collected by researches blinded to group assignment |
| 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 |