Methods | RCT. | |
Participants | 600 nulliparous, low-income, under-insured pregnant women (300 doula group, 300 control group) booked for delivery at a hospital in New Jersey, USA were enrolled between 12 and 38 weeks’ gestation. They were considered low risk, with no contraindications to labour and had a female friend or relative willing to act as their lay doula. The doula was in addition to support people of their own choosing | |
Interventions | Intervention: continuous support by a female friend or relative who had had 2, 2-hour sessions about labour support. The training sessions were conducted for nearly all of the lay caregivers when the participants were 34-36 weeks’ gestation Control group: support people of their own choosing. |
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Outcomes | Labour length, epidural analgesia, oxytocin augmentation, cervical dilation at epidural insertion, length of second stage labour, caesarean birth, 1-min Apgar score > 6, 5-min Apgar score > 6 | |
Notes | Epidural analgesia was available and EFM was used routinely. | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | ‘Computer generated randomization scheme.’ |
Allocation concealment (selection bias) | Low risk | Consecutively-numbered, sealed opaque envelopes contained treatment assignments. After obtaining consent, a research assistant opened the next envelope. It was unclear whether the research assistant enrolling the woman was the same one that opened the envelope |
Blinding (performance bias and detection bias) All outcomes |
High risk | Medical record abstraction was done by the author who was not blinded. The 6-week questionnaire data collection was not blinded |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Medical record information was completed for 97.7% of the sample (82.3% in the intervention group and 94.3% in the control group). The differential rates are due to withdrawals from the intervention group for doula related reasons (incomplete training and not being present during labour). The 6-week questionnaire was completed for 82.3% of the sample. Only those women included in the study at delivery had the opportunity to complete the questionnaire and thus the differential completion rate between groups remained (76.3% in the intervention group and 88.3% in the control group). The differential withdrawals could introduce selection bias |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Unclear risk | The training of the doulas giving the intervention was done by the research assistant, who was herself a doula. This same research assistant enrolled all study participants |