| Methods |
Randomized controlled trial, women were enrolled early in pregnancy at first booking appointment. |
| Participants |
2844 nulliparous and multiparous women (1900 in experimental group and 944 in control group) who were low‐risk at booking at a hospital in Aberdeen, Scotland. Exclusion criteria were: age > 35, height < 150 cm, pre‐existing maternal disease, history of infertility or prior obstetric complications, multiple pregnancy. |
| Interventions |
Experimental: antenatal care and delivery in a midwife‐managed, alternative unit 20 yards from the hospital's delivery suite. Strict protocols were in place for booking, admission, and transfer of women. Labour was managed with minimal intervention and fetal monitoring by intermittent auscultation. Control: care in the consultant‐led delivery suite. The midwives' unit was staffed by hospital midwives who also worked in the delivery suite. |
| Outcomes |
Number transferred from care in the midwives' unit and reason for transfer, type of fetal heart rate monitoring, fetal distress, meconium staining in labour, shoulder dystocia, undiagnosed malpresentation, induction of labour, augmentation of labour, delay in 1st and 2nd stage labour, intrapartum analgesia, mobility in labour, perineal trauma, mode of delivery, neonatal resuscitation, neonatal intensive care unit admission, stillbirths and neonatal deaths, satisfaction with care, costs. |
| Notes |
54% of those allocated to the experimental group were not delivered in the midwives' unit. 1.5% were lost to follow‐up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Stated as 'simple unstratified'. 2:1 randomization scheme favouring the experimental group. |
| Allocation concealment (selection bias) |
Low risk |
Consecutively‐numbered, sealed opaque envelopes. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not stated if data collectors were blinded to allocation group. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcome data collected on 96% of those randomized. Questionnaires completed by 87% of those randomized. |
| Selective reporting (reporting bias) |
Low risk |
Results were listed for all study outcomes. |
| Other bias |
Low risk |
No other potential sources of bias were noted. |
