North Stafford 2000.

Methods	Study design: RCT, cluster randomisation. Duration of study: not stated.
Participants	Setting: tertiary hospital and community, UK. Inclusion criteria: 'all‐risks’. Exclusion criteria: not stated. Participants randomised: 770 midwife‐led caseload care, 735 standard care (shared care).
Interventions	Experimental: caseload midwife‐led care. 3 geographic areas with 21 WTE midwives working in 3 practices offering a caseload model of care. Each midwife was attached to 2‐3 GP practices and cared for 35‐40 women. Midwives worked in pairs/threesomes. Caseload midwives were existing community midwives, plus new midwives recruited from community and hospital resulting in a mix of senior and junior staff. Monthly antenatal care in the community, intrapartum and postnatal care in hospital and postnatal care in the community provided. Control: shared care in the community between GPs, community midwives and obstetricians. Each community midwife cared for 100/150 women each.
Outcomes	Outcomes considered in the review and reported in or extracted from the study: 5‐minute Apgar score below or equal to 7 Admission to special care nursery/NICU Attendance at birth by known midwife Augmentation/artificial oxytocin during labour Caesarean birth Episiotomy Fetal loss/neonatal death equal to/after 24 weeks Induction of labour Instrumental vaginal birth (forceps/vacuum) Intact perineum Low birthweight (< 2500 g) Fetal loss and neonatal death Perineal laceration requiring suturing Preterm birth (< 37 weeks) Regional analgesia (epidural/spinal)
Notes	95% of experimental group and 7% of standard group had previously met midwife attending labour.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	'Randomisation was undertaken by one of the principal investigators...who had no prior knowledge of the area or medical and midwifery staff involved.... three pairs, one of each...randomised to receive caseload care and the other to traditional care.'
Allocation concealment (selection bias)	High risk	No information given about allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	'It was not possible to mask allocation and both women and professionals were aware of the allocated type of midwifery care.'
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated but unlikely.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up: not reported but appears complete.
Selective reporting (reporting bias)	Low risk	Outcome reporting: all outcomes stated in the methods section were adequately reported or explained in results.
Other bias	Low risk	No other bias identified.