Bergstrom 2009.
Methods | Randomised trial | |
Participants | Sweden Inclusion criteria: Nulliparous, Swedish‐speaking and attending any of the participating clinics. No specific inclusion criteria were defined for the women's partners |
|
Interventions | Intervention: antenatal education focusing on natural childbirth preparation with training in breathing and relaxation techniques (psychoprophylaxis) Control: standard antenatal education focusing on both childbirth and parenthood, without psychoprophylactic training Both groups: four 2‐hour sessions in groups of 12 participants during third trimester of pregnancy and one follow‐up after delivery |
|
Outcomes | Mode of delivery, epidural analgesia, experience of childbirth, and parental stress in early parenthood | |
Notes | Baseline (Control group) CS rate: 21% Date of study: October 2005 to February 2007 Funding: Swedish Research Council and Karolinska Institute Conflicts of interest: the authors declare that they have no known conflict of interests. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomisation was conducted by the computerised algorithm with two priorities: Stratification by (1) equal number of participants per model in all clinics taken together and (2) balancing the numbers of each model within the respective clinic." |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided in the report |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information provided in the report |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Main outcomes (modes of delivery) objective |
Baseline characteristics similar? | Low risk | Baseline characteristics in study groups similar (Table 1 in the article) |
Baseline outcome measurements similar? | Unclear risk | Baseline measures of main outcomes not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers lost to follow‐up (Figure 1 in the article) unlikely to bias effect estimates |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported |
Protected against contamination? | High risk | Some women in standard care also got psychoprophylaxis education at home |
Other bias | High risk | Unit of analysis issues: “We have analysed data of individuals in spite of the fact that exposures was given to groups of individuals.” |