Methods | RCT. | |
Participants | 435 women (217 in companion group, 218 in control group) with a singleton pregnancy and considered to be low-risk at University Hospital in Santiago, Chile. Enrolled at 34-36 weeks’ gestation | |
Interventions | Intervention group: psychosocial support during labour from a companion chosen by the pregnant woman. The companions were trained by trial staff to provide emotional support, promote physical comfort and encourage progress of labour, without interfering with the activities of the obstetricians or midwives. They were with the labouring woman continuously from admission to delivery. Women were encouraged to pick a companion who had experienced a vaginal birth Control group did not have companion. Both groups laboured in a room with other women where curtains were pulled for privacy |
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Outcomes | Caesarean section, exclusive breastfeeding, duration of labour, mode of delivery, use of oxytocics, presence of meconium, regional anaesthesia, birth asphyxia, Apgar scores, level of neonatal care, maternal satisfaction | |
Notes | Epidural analgesia was available. It was not stated if EFM was used routinely. Authors have been contacted for further details | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer-generated list of random numbers. |
Allocation concealment (selection bias) | Low risk | Used blocks of 6. Group assignment used sealed opaque envelopes numbered consecutively. A member of the trial team enrolled women and did not know in advance the content of each envelope |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Medcial record data were collected for 100% of the sample and in-hospital surveys were completed by 95.8%. A 6-week phone interview was completed for 71.2%of the sample and thus these data were not used |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Low risk | No other sources of bias noted. |