|First author [year]||Research aim||Study design||Country/Setting (site numbers)||Maternal group||Sample size||Intervention type/ Maternal period of study||Intervention and comparison regimen||Results for primary outcome|
|Althabe ||To test the hypothesis that a hospital policy of mandatory second opinion reduces hospital CS rate by 25% without increasing maternal and perinatal morbidity and mortality.||Cluster RCT||Argentina, Brazil, Cuba, Guatemala, Mexico/Hospital (36 sites)||Pregnant women giving birth||36 hospitals randomised/34 hospitals (17 in each arm) and 149,276 women (I: 70410/C: 78866) at completion.||Hospital policy of mandatory second opinion/Labour and Birth||
Intervention group: 6-month implementation of a hospital policy of mandatory second opinion before non-emergency CS. Second opinion was sought by the attending physician with a consultant physician with clinical qualifications equal to or higher than the attending physician. Cases were discussed in relation to a suite of prepared guidelines.|
Comparison group: Routine care.
|+ (relative rate reduction 7.3%, p = 0.044)|
|Begley ||To compare midwife-led versus consultant-led care for healthy, pregnant women without risk factors for labour and delivery.||Pragmatic RCT||Ireland/Hospital (2 sites)||Pregnant women (17–39 years, healthy, < 24 weeks gestation at booking, low-risk)||1653 women (I: 1101/C: 552)||Midwife-led model of care/Pregnancy, Labour and Birth, Postnatal||
Midwife-led care group: Care provided by the same small group of midwives in the midwifery-led unit consisting of pregnancy care (including assessment) by midwives and, if desired, the woman’s GP; labour and birth care by midwives; postnatal care by midwives for up to two days. On discharge, midwives visited women at home, and/or provided telephone support, up to the 7th postpartum day, when care was transferred to the Public Health Nursing service.|
Comparison group: Standard care consisting of pregnancy care provided by obstetricians and, if desired, the woman’s GP, supported by the hospital medical team with assistance from midwives; labour and birth care by midwives unless complications developed, with consultant overview; and postpartum care by midwives, overseen by consultants; discharged into the care of Public Health Nurses.
|X (RR 0.97, 95% CI 0.76 to 1.24)|
|Chaillet ||To assess whether a multifaceted intervention to promote professional onsite training with audit and feedback would reduce the rate of caesarean delivery and other maternal and neonatal outcomes.||Cluster RCT||Canada/Hospital (32 sites)||Pregnant women giving birth||32 hospitals (16 in each arm). Primary analysis based on 105,351 women (pre-intervention 53,086; post-intervention 52,265)||Audit and feedback, Implementation of evidence-based practice/Labour and Birth||
Intervention group: Multifaceted 1.5-year intervention, consisting of training in evidence-based clinical practices, audits of indications for caesarean delivery, the provision of informal and formal feedback to health professionals, and implementation of best practices.|
Comparison group: No intervention.
|+ (Adj. OR 0.90, 95% CI 0.80 to 0.99, p = 0.04)|
|Chambliss ||To test the hypothesis that the low caesarean birth rate on the midwifery service was the result of patient selection bias.||RCT||USA/Hospital (1 site)||Pregnant women (16–45 years, singleton vertex presentation, 36–42 weeks gestation, foetal size estimation of 2500-4000 g) in labour||487 women (I: 234/C: 253)||Midwife-led model of care/Labour and Birth||
Intervention group: Women were managed in the birth centre using previously established protocols. Care exclusively provided by midwives, unless physician consultation was sought. Midwife-led careliberally uses ambulation, varied positions for birth, and a support person as an integral part of labour management.|
Comparison group: Women were managed in the labour and birthing ward. This ward is directed by a senior resident primarily responsible for management decisions, in consultation with an attending physician. The service rarely uses ambulation, does not use birthing beds (instead a lithotomy position on a delivery table), patients rarely have a coach or support person, and epidural anaesthesia is common.
|X (p > 0.05)|
|Gagnon ||To compare the risks and benefits of one-to-one nurse labour support with usual labour and birth care.||RCT||Canada/Hospital (1 site)||Pregnant women (nulliparous, ≥37 weeks gestation, singleton) in labour||413 women (I: 209/C: 204)||Continuous Midwifery Care/Labour and Birth||
Intervention group: Continuous one-to-one nursing care from the time of randomisation until one hour after birth. During this time, in addition to the usual labour and birth care (including foetal monitoring and intravenous regulation), the nurse provided physical comfort, emotional support, and instruction on relaxation and coping techniques to the woman; gave support to the expectant father; contacted the attending physician; contacted the anaesthesiologist when appropriate; and updated the unit staff on the progress of labour.|
Comparison group: Usual labour and birth care.
|X (RR 0.86, 95% CI 0.54 to 1.36)|
|Gu ||To develop and implement a midwife-led pregnancy clinic service in China and explore its effect on childbirth outcomes, psychological state and satisfaction.||RCT||China/ Hospital (1 site)||Pregnant women (Mandarin-speaking, primiparous 29–30 weeks gestation at recruitment; low risk, singleton)||110 women randomised (I: 55/ C:55)/ 106 women included in final analysis (I: 53/C:53)||Midwife-led model of care/ Pregnancy ± Labour and Birth/ Postnatal (up to 2 h)||
Intervention group: Women received individual care from a specially trained, experienced midwife following each pregnancy obstetrician appointment. The midwife typically focussed on pregnancy check-ups, consultation, making birth plans, parent education, and collaborated with obstetricians. The midwife was on call for the woman’s labour and birth except in designated circumstances, in which case an associate midwife would be present. Each women had a chance of chance of having continuous one-to-one care from the onset of labour to 2 h postpartum.|
Comparison group: Women received routine obstetrician-led pregnancy care. This included consultations with obstetricians who could differ at each visit; being cared for in labour and birth by rostered midwives and obstetricians. Each woman had a chance of receiving one-to-one continuity of care by a duty midwife from the onset of labour to 2 h postpartum.
|+ (Difference − 22.64, 95% CI −41.60 to −3.69, p = 0.019)|
|Harvey ||To determine if nurse-midwifery care was as effective as traditional medical care for low-risk women with respect to clinical outcomes.||RCT||Canada/ Hospital (1 site)||Pregnant women (low-risk, ≥20 weeks gestation at study entry)||194 women (I: 101/ C: 93)||Midwife-led model of care/ Pregnancy, Labour and Birth, Postnatal||
Intervention group: Women received care from a team of seven nurse-midwives who provided complete management of those with uncomplicated pregnancies. Protocols and guidelines for the care were based on the midwifery philosophy and standards of practice developed by the Alberta Association of Midwives. Women were seen during pregnancy in the nurse-midwifery clinic. A nurse-midwifery team member provided care throughout the labour, birth, and immediate postpartum period. A member of the team carried out postpartum follow-up in the postpartum unit or at home, and a 6-week follow-up visit was performed in the midwifery clinic.|
Comparison group: Women selected their physician through standard referral processes, and were free to use any family practice physician or obstetrician in the area.
|+ (p = 0.01, 95% CI for difference 2.9 to 19.3%)|
|Hodnett ||To evaluate the effectiveness of nurses as providers of labour support in hospitals.||RCT||USA & Canada/ Hospital (13 sites)||Pregnant women (singleton or twin, ≥34 weeks gestation) in established labour||6915 women (I: 3454/ C: 3461)||Continuous Midwifery Care/Labour and Birth||
Intervention group: Women received continuous labour support (minimum 80% nurse time from randomisation to birth) from specially trained nurses.|
Comparison group: Usual care.
|X (p = 0.44)|
|Homer ||To test whether a new community-based model of continuity of care provided by midwives and obstetricians improved maternal clinical outcomes, in particular a reduced CS rate.||RCT||Australia/ Hospital (1 site)||Pregnant women (< 24 weeks gestation at first visit, < 2 prior caesarean deliveries)||1089 women (I: 550/ C: 539)||Midwife-led model of care/Pregnancy, Labour and Birth, Postnatal||
Intervention group: Community-based model with a team of six full-time midwives - the emphasis was on continuity of care (a consistent team approach) rather than carer (the same midwife). Two midwives and an obstetrician or obstetric registrar attended each clinic. Two teams were involved and one midwife from each was always on call for women in labour and to provide advice and information. After the birth, women could either choose to remain in hospital for postnatal care with community-based midwives or be discharged early and receive domiciliary care by the community-based midwives.|
Comparison group: Standard care provided in the hospital-based pregnancy clinic, the birthing suite and the postnatal ward. Midwives and doctors saw women in the pregnancy clinic. Women with risks were seen by an obstetrician or obstetric registrar; low-risk women by midwives. Hospital-based pregnancy care included visits to the women’s GP (i.e. shared care). Midwives and doctors on duty provided care in the birthing suite and the postnatal ward. Standard care was characterised by a lack of continuity of care across the pregnancy, labour and birth and postnatal periods as a large number of clinicians provided care.
|+ (OR 0.6, 95% CI 0.4 to 0.9, p = 0.02)|
|Janssen ||To compare rates of caesarean birth among women who were triaged by obstetric nurses at home visits vs telephone.||RCT||Canada/ Hospital & Home (7 sites)||Pregnant women (16–42 years, 37–41 weeks gestation, nulliparous, singleton vertex presentation, ± induced on an outpatient basis with prostaglandins) in labour||1459 women (I: 728/ C: 731)||Labour Assessment Triage/ Labour||
Home-triage (intervention) group: Women received a nursing assessment at home (identical to that received by the control group over telephone) and received an assessment that included maternal vital signs, abdominal palpation, auscultation of the foetal heart rate, assessment of contractions, and examination of the cervix. Comfort measures were taught to the woman and her support person/s as needed. The study nurse contacted the primary physician by telephone following assessment and a joint decision made whether to remain at home longer. If needed, a woman could be assessed at home more than once. Women could access the study nurse via phone at any time.|
Telephone-triage (comparison) group: Women were asked questions over the telephone about the nature of contractions, presence of bloody show, status of membranes, colour of amniotic fluid, presence of bleeding, nature of foetal movements, and their own coping assessment. Suggestions for coping were made over the phone. Women could access the study nurse via phone at any time.
|X (RR: 1.12, 95% CI 0.94 to 1.32)|
|Kashanian ||To evaluate the effect of continuous support provided by midwives during labour on the duration of the different stages of labour and the rate of caesarean delivery.||RCT||Iran/ Hospital (1 site)||Pregnant women (nulliparous, 18–34 years, low-risk, 38–42 weeks gestation, singleton cephalic presentation, estimated foetal weight of 2500–3400 g, cervical dilatation of 3–4 cm with appropriate contractions) in labour||100 women (I: 50/ C: 50)||Continuous Midwifery Care/ Labour and Birth||
Intervention group: Women were shown to an isolated room and were supported by an experienced midwife. Women were free to choose their position, and were able to eat and walk about freely. During labour, the midwife explained the process of labour and the importance of body relaxation. Midwife-led support included close physical proximity, touch, eye contact with the labouring women, and teaching, reassurance, and encouragement. The midwife remained with the woman throughout labour and birth, and applied warm or cold packs to the woman’s back, abdomen, or other parts of the body, as well as performing massage according to each woman’s request.|
Comparison group: Women were admitted to the labour ward, did not receive continuous support, and care followed the routine procedures. Women did not have a private room, did not receive one-to-one care, were not permitted food, and did not receive education and explanation about the labour process. The only persons allowed in the birthing room were nurses, midwives, and doctors.
|+ (p = 0.026)|
|McLachlan ||To determine whether primary midwife care (caseload midwifery) decreases the CS rate compared with standard maternity care.||RCT||Australia/ Hospital (1 site)||Pregnant women (< 24 completed weeks gestation, singleton pregnancy, low obstetric risk at recruitment)||2314 women randomised (I: 1156/ C: 1158)/ 2286 included in final analysis (I: 1142/ C: 1144)||Midwife-led model of care/ Pregnancy, Labour and Birth, Postnatal||
Intervention group: Women received the majority of their care from a ‘primary’ caseload midwife at the hospital. If complications developed, the primary midwife collaborated with obstetrician/ health professionals and continued to provide caseload care. The primary midwife was on call for the woman’s labour. Labour and birth care was provided in the hospital birthing suite. The primary midwife attended the hospital on most days to provide some postnatal care and provided domiciliary care following discharge.|
Comparison group: Standard care options for women included midwifery-led care with varying levels of continuity, obstetric trainee care and community-based care ‘shared’ between a GP and the participating hospital, where the GP provided the majority of pregnancy care. Women were cared for by rostered midwives and doctors for labour, birth and postnatal care.
|+ (RR 0.78, 95% CI 0.67 to 0.91, p = 0.001)|
|Rowley ||To compare continuity of care from a midwife team with routine care from a variety of doctors and midwives.||Stratified RCT||Australia/ Hospital (1 site)||Pregnant women||814 women (I: 405/ C: 409)||Midwife-led model of care/ Pregnancy, Labour and Birth, Postnatal||
Intervention group: Women received pregnancy care, one-to-one labour and birth care, and early postnatal care by a team of 6 experienced and newly graduated midwives. Low-risk women were seen by a midwife at each visit but also had 3 consultations with a doctor. High-risk women had an individualised care plan devised in consultation with a doctor. They were seen by a midwife and a doctor at each visit, at a frequency determined by their risk status. Throughout labour, one of the team midwives provided care.|
Comparison group: Women received pregnancy care, labour and birth care, and early postnatal care by a variety of doctors and midwives working in the pregnancy clinic, birthing suite and postnatal area.
|X (Planned CS: OR 0.82, 95% CI 0.45 to 1.52; Unplanned CS: 0.99, 95% CI 0.58 to 1.67)|
|Tracy ||To assess the clinical and cost outcomes of caseload midwifery care for women irrespective of risk factors.||RCT||Australia/ Hospital (2 sites)||Pregnant women (≥18 years, < 24 weeks gestation at first visit, single foetus, planning to have vaginal birth)||1748 women (I: 871/ C: 877)||Midwife-led model of care/ Pregnancy, Labour and Birth, Postnatal||
Intervention group: Women received pregnancy, labour and birth, and postnatal care in hospital and in the community from a named (or primary) caseload midwife, who worked within a small group known as a midwifery group practice. Women also received postnatal care at home from their caseload midwife for up to 6 weeks.|
Comparison group: Women chose from the standard hospital options for maternity care, which did not include substantial continuity of a midwifery carer. Standard hospital care was provided through antenatal clinics, labour wards, and postnatal wards, with care provided by rostered doctors and midwives.
|X (OR 0·88, 95% CI 0·70 to 1·10, p = 0·26)|
|Yavangi ||To evaluate the effectiveness of Iranian Ministry of Health and Medical Education protocols on CS rate trends.||Non-concurrent controlled quasi-experimental study||Iran/ Hospital (2 sites)||Pregnant women hospitalised with complications (premature rupture of membranes, prolonged pregnancy, pre-eclampsia, intrauterine growth retardation, vaginal bleeding, and premature labour in 1st /2nd trimester).||1172 women (I: 578/ C: 594)||Hospital protocols for pregnancy complications/ Pregnancy||
Intervention group: Women hospitalised from December 2008 to April 2009 underwent interventions based on newly developed protocols for managing pregnancy complications.|
Comparison group: Women hospitalised from April 2008 to October 2008 were treated based on previous routine approaches and underwent no intervention based on the new protocols.
|-(p = 0.001)|