Begley 2011.

Methods	Study design: RCT. Duration of study: 2004‐2007.
Participants	Setting: Health Service Executive, Dublin North‐East, Republic of Ireland. Inclusion criteria: women were eligible for trial entry if they were: (a) healthy with an absence of risk factors for complications for labour and delivery as identified in the ‘Midwifery‐led Unit (Integrated) Guidelines for Practitioners’ (at http://www.nehb.ie/midu/guidelines.htm); (b) aged between 16 and 40 years of age; and (c) within 24 completed weeks of pregnancy. Exclusion criteria: women with risk factors. Participants randomised: 1101 midwife‐led care, 552 to CLC.
Interventions	Experimental: women randomised to midwife‐led care (MLU) received antenatal care from midwives and, if desired, from their GPs for some visits. Where complications arose, women were transferred to CLU based on agreed criteria. Intrapartum care was provided by midwives in a MLU with transfer to CLU if necessary. Postnatal care was by midwives in the MLU for up to 2 days, with transfer of women or neonates to CLU if necessary (and back, as appropriate). On discharge, MLU midwives visited at home, and/or provided telephone support, up to the seventh postpartum day. Control: women randomised to consultant‐led care (CLU) received standard care: antenatal care provided by obstetricians supported by the midwifery and medical team; intrapartum and postpartum care (2 to 3 days in hospital) provided by midwives, overseen by consultants. Women were discharged into the care of Public Health Nurses.
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 Amniotomy Antenatal hospitalisation Antepartum haemorrhage Augmentation/artificial oxytocin during labour Breastfeeding initiation Caesarean birth Duration of postnatal hospital stay (days) Episiotomy Fetal loss/neonatal death before 24 weeks Fetal loss/neonatal death equal to/after 24 weeks Induction of labour Instrumental vaginal birth (forceps/vacuum) Intact perineum Low birthweight (< 2500 g) Mean labour length Mean length of neonatal hospital stay (days) Neonatal convulsions (as defined by trial authors) No intrapartum analgesia/anaesthesia Opiate analgesia Fetal loss and neonatal death Perineal laceration requiring suturing Preterm birth (< 37 weeks) PPH (as defined by trial authors) Regional analgesia (epidural/spinal) Spontaneous vaginal birth (as defined by trial authors) Cost
Notes	Women were randomised to MLU or CLU in a 2:1 ratio. Kenny 2015 reports an economic analysis ‐ a comparison of the cost of care of the 2 types of services. We have described these results above ‐ data added 2016 update.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	‘Random integers were obtained using a random number generator…’
Allocation concealment (selection bias)	Low risk	‘…an independent telephone randomisation service.’
Blinding of participants and personnel (performance bias) All outcomes	High risk	'...lack of blinding of participants and carers...'
Blinding of outcome assessment (detection bias) All outcomes	High risk	'Assessors for certain outcomes, such as laboratory tests, were blinded to study group.'
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up = 5 midwife‐led care, 3 CLC.
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.