The contribution of midwife-led care to the quality and safety of maternity care : implications of findings from a Cochrane meta-analysis Jane Sandall Professor of Women’s Health, King’s College London Hatem M, Sandall, J. (Joint First Author and Contact Author) Devane D, Soltani H. Gates,S. October 2009

Background Maternal and neonatal morbidity and mortality together one of the biggest challenges to public health in developing countries. Evidence base on patient safety, its root causes and contributing factors, as well as on the most cost-effective solutions to common problems is very limited. Maternal and neonatal care in top 20 WHO Patient Safety Programme global research priorities in low and mid income countries. [1] In 2002, WHO Member States agreed on a World Health Assembly resolution on patient safety. Defined as ‘the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum‘. [i] Lawn JE, Cousens S, Zupan J. (2005) 4 million neonatal deaths: When? Where? Why? Lancet ;365(9462):891-900. [ii] World Health Organisation (2008) Patient Safety Global priorities for research in patient safety research (first edition), The Research Priority Setting Working Group, http://www.who.int/patientsafety/research/priorities/global_priorities_patient_safety_research.pdf accessed 23/9/09 [iii] Althabe F, Bergel E, Cafferata ML, Gibbons L, Ciapponi A, Aleman A, et al. (2008) Strategies for improving the quality of health care in maternal and child health in low- and middle-income countries: an overview of systematic reviews. Paediatric and Perinatal Epidemiology;22(Suppl. 1):42-60.

Improving quality and safety in maternity care The Institute of Medicine (IOM) defines quality of health care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge”.  Crossing the Quality Chasm (2001)

Dimensions of quality Safety Effectiveness Patient/woman-centeredness Timeliness Efficiency Equity Institute of Medicine (2000) Crossing the Quality Chasm: A New Health System for the 21st Century, Washington, National Academy Press

What is the evidence? Improving the coverage of skilled midwifery care has been identified by the WHO and a range of other agencies as delivering on the above agenda.

Cochrane review midwife-led models of care vs other models of care Midwife-led model of care assumes: pregnancy and birth are normal life events and is woman-centred and includes: continuity of care; monitoring the physical, psychological, spiritual and social well-being of the woman and family throughout the childbearing cycle; providing the woman with individualised education, counselling and antenatal care; continuous attendance during labour, birth and the immediate postpartum period; ongoing support during the postnatal period; minimising technological interventions; and identifying and referring women who require obstetric or other specialist attention. Differences between midwife-led and other models of care often include variations in philosophy, focus, relationship between the care provider and the pregnant woman, use of interventions during labour, care setting (home, home-from-home or acute hospital setting, and in the goals and objectives of care.

What we didn’t know before review Clinical and cost effectiveness of the different models of maternity care The optimal model of care for routine antenatal, intrapartum and postnatal care for healthy pregnant women Synthesised information to establish whether there are differences in morbidity and mortality, effectiveness and psychosocial outcomes between midwife-led and other models of care

What Is The Cochrane Library? The Cochrane Library is the single most reliable source for evidence on the effects of health care. Health care in the 21st Century relies not only on individual medical skills, but also on the best information on the effectiveness of each intervention being accessible to practitioners, patients, and policy makers. This approach is known as “evidence-based medicine”.

Cochrane Reviews are now the “gold standard” for systematic reviews in such key publications as The Lancet, New England Journal of Medicine, British Medical Journal, and the Journal of the American Medical Association and routinely appear there as well as in specialised medical journals for various specialty areas.

Review Objectives Primary to compare midwife-led models of care with other models of care for childbearing women and their infants. Secondary to determine whether the effects of midwife-led care are influenced by: 1) models of midwifery care that provide differing levels of continuity; 2) varying levels of obstetrical risk and 3) practice setting (community or hospital based).

Definition of midwife-led care “midwife is the lead professional providing continuity in the planning, organisation and delivery of care given to a woman from initial booking to the postnatal period". Some antenatal and/or intrapartum and/or postpartum care may be provided in consultation with medical staff as appropriate. Midwives are lead professional with responsibility for assessment of her needs, planning her care, referral to other professionals as appropriate. Thus, midwife-led models of care aim to provide care in either community or hospital settings, normally to healthy women with uncomplicated or 'low-risk' pregnancies. In the review, models of care were classified as ‘midwife-led’, or ‘other’ on the basis of the lead professional in the ante and intrapartum periods, with the rationale that decisions and actions taken in pregnancy affect intrapartum events.

Models of midwife-led care Team midwifery Aim to provide continuity of care to a defined group of women through a team of midwives sharing a caseload, often called 'team' midwifery. Thus, a woman will receive her care from a number of midwives in the team, the size of which can vary. Caseload midwifery Aim to offer greater relationship continuity over time, by ensuring that a childbearing woman receives her ante, intra and postnatal care from one midwife or her/his practice partner.

Other models of care Obstetrician-provided care Obstetricians are the primary providers of antenatal care. An obstetrician (not necessarily the one who provides antenatal care) is present for the birth. (b) Family doctor-provided care Obstetric nurses or midwives provide intrapartum and immediate postnatal care but not at a decision making level, and a family doctor is present for the birth. (c) Shared models of care Where responsibility for the organisation and delivery of care, throughout initial booking to the postnatal period, is shared between different health professionals.

Criteria for considering studies for this review Types of studies   All studies in which pregnant women are randomly allocated to midwife-led models of care and other models of care during pregnancy. Types of participants   Pregnant women classified as low and mixed risk of complications. Types of interventions   Models of care are classified as midwife-led, other or shared care on the basis of the lead professional in the ante and intrapartum periods, as decisions and actions taken in pregnancy affect intrapartum events and continuity of care a key part of model.

Search methods for identification of studies No language restrictions, published and unpublished reports Electronic searches Cochrane Pregnancy and Childbirth Group’s Trials Register Cochrane Central Register of Controlled Trials (CENTRAL) Cochrane Effective Practice and Organisation of Care Group's Trials Register Current Contents, Medline, CINAHL Web of Science, BIOSIS, Previews, ISI Proceedings, WHO Reproductive Health Library Unpublished studies from the System for Information on Grey Literature In Europe (SIGLE) Handsearches 30 journals and proceedings of major conferences Current awareness alerts for additional 44 journals Details can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group

Details of studies 11 trials involving 12,276 randomised women Public health systems in Australia, Canada, New Zealand and the United Kingdom with variations in model of care, risk status of participating women and practice settings. Two studies offered a caseload team model of care and nine studies provided a team model of care. Levels of continuity (measured by the percentage of women who were attended during birth by a known carer varied between 63% to 98% for midwife-led models of care to 0.3% to 21% in other models of care). Some midwife-led models included routine visits to the obstetrician or family physicians (GPs), or both. The frequency of such visits varied and were dependent on women's risk status during pregnancy Women classified as being at low risk of complications in six studies and as mixed risk in five studies The midwifery models of care were hospital-based in four studies or offered (i) antenatal services in an outreach community-based clinic and intra- and postpartum care in hospital); (ii) ante- and postpartum community-based care with intrapartum hospital-based care) or (iii) postnatal care in the community with hospital-based ante- and intrapartum care Three studies offered intrapartum care in homelike settings, either to all women in the trial, or to women receiving midwife-led only 11 trials involving 12,276 randomised women

Safety Defined as ‘avoiding injuries to patients from the care that is intended to help them’. Drawing on the IOM definition of dimensions of quality - safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity, what does midwife-led care contribute?

Fetal loss before 24 weeks Women randomized to midwife-led models of care were less likely to experience fetal loss or neonatal death less than 24 weeks (eight trials, n = 9890, risk ratio (RR) 0.79, 95% confidence interval (CI) 0.65 to 0.97), fixed effects analysis There were no statistically significant differences between groups for total fetal loss/neonatal death or more than or equal to 24 weeks. Overall, there was no increased likelihood for any adverse outcome for women or their infants associated with having been randomized to a midwife-led model of care. These results were moderate in magnitude and generally consistent across all the trials. Event rate The proportion of patients in a group for whom a specified health event or outcome is observed. Thus, if out of 100 patients, the event is observed in 27, the event rate is 0.27 or 27%. Confidence Interval A way of expressing certainty about the findings from a study or group of studies, using statistical techniques. A confidence interval describes a range of possible effects (of a treatment or intervention) that are consistent with the results of a study or group of studies. A wide confidence interval indicates a lack of certainty or precision about the true size of the clinical effect and is seen in studies with too few patients. Where confidence intervals are narrow they indicate more precise estimates of effects and a larger sample of patients studied. It is usual to interpret a ‘95%’ confidence interval as the range of effects within which we are 95% confident that the true effect lies. Relative Risk A summary measure which represents the ratio of the risk of a given event or outcome (e.g. an adverse reaction to the drug being tested) in one group of subjects compared with another group. When the ‘risk’ of the event is the same in the two groups the relative risk is 1. In a study comparing two treatments, a relative risk of 2 would indicate that patients receiving one of the treatments had twice the risk of an undesirable outcome than those receiving the other treatment. Relative risk is sometimes used as a synonym for risk ratio. Homogeneity. The term is used in meta-analyses and systematic reviews when the results or estimates of effects of treatment from separate studies seem to be very different – in terms of the size of treatment effects or even to the extent that some indicate beneficial and others suggest adverse treatment effects. Such results may occur as a result of differences between studies in terms of the patient populations, outcome measures, definition of variables or duration of follow-up. Risk reduction of 21%

Effectiveness Defined as ‘providing services based on sound scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit (avoiding underuse and overuse respectively)’.

Women randomised to midwife-led models of care were less likely to experience regional analgesia/anesthesia (11 trials, n = 11,892, RR 0.81, 95% CI 0.73 to 0.91) 19% less instrumental (forceps/vacuum) birth (10 trials, n = 11,724, RR 0.86, 95% CI 0.78 to 0.96) 14% less episiotomy (11 trials, n = 11,872, RR 0.82, 95% CI 0.77 to 0.88) 18% less no significant differences in the caesarean section rate (11 trials, n = 11897, RR 0.96, 95% CI 0.87 to 1.06

Midwife-led versus other models of care for childbearing women and their infants - Instrumental birth Risk reduction of 14%

Women randomized to midwife-led models of care were more likely to experience no intrapartum analgesia/anesthesia (five trials, n = 7039, RR 1.16, 95% CI 1.05 to 1.29) a spontaneous vaginal birth (nine trials, n = 10,926, RR 1.04, 95% CI 1.02 to 1.06) breastfeeding initiation (one trial, n = 405, RR 1.35, 95% CI 1.03 to 1.76)

Woman – centeredness Defined as ‘providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions’.

Women randomized to midwife-led models of care were more likely to experience high perceptions of control during labour (one trial, n = 471, RR 1.74, 95% CI 1.32 to 2.30) attendance at birth by a known midwife (six trials, n = 5525, RR 7.84, 95% CI 4.15 to 14.81)

Experience of care Women's reported experiences of care included maternal satisfaction with information, advice, explanation, venue of delivery and preparation for labour and birth, as well as perceptions of choice for pain relief and evaluations of carer's behaviour. Satisfaction in various aspects of care appeared to be higher in the midwife-led compared to the other model of care.

Attendance at birth by a known midwife Women nearly X8 times more likely to know midwife 26

Efficiency Defined as avoiding waste, including waste of equipment, supplies, ideas and energy.

Efficiency All trials suggest a cost-saving effect in intrapartum care. Lack of consistency in estimating maternity care cost among the available studies; however there seemed to be a trend towards the cost-saving effect of midwife-led care in comparison with medical-led care.

Women randomized to midwife-led models of care were less likely to experience antenatal hospitalization In addition, infants of women randomized to midwife-led models of care had a shorter mean length of stay in hospital (two trials, n = 259, mean difference (WMD) -2.00 days, 95% CI -2.15 to -1.85, random effects analysis) than infants of women randomized to other models of care. Risk reduction of 10%

There were no statistically significant differences between groups for: antepartum haemorrhage preterm birth low birthweight infant amniotomy the use of opiate analgesia augmentation during labour induction of labour caesarean section rate perineal laceration requiring suturing intact perineum five-minute Apgar score less than or equal to seven admission of infant to special care or neonatal intensive care unit(s) neonatal convulsions fetal loss or neonatal death more than or equal to 24 weeks overall fetal loss and neonatal death duration of postnatal hospital stay postpartum depression

Overall fetal loss Non-significant trend risk reduction of 17% 31

Summary Women who received models of midwife-led care were nearly eight times more likely to be attended at birth by a known midwife, were 21% less likely to lose their baby before 24 weeks, 19% less likely to have regional analgesia, 14% less likely to have instrumental birth, 18% less likely to have an episiotomy, and significantly more likely to have a spontaneous vaginal birth, initiate breastfeeding, and feel in control during childbirth. Thus in addition to enhancing normal birth, the contribution of midwife-led care to the quality and safety of health care is substantial. The implications for policymakers and service providers are outlined along with suggestions for future research.

Conclusion “Every women needs a midwife and some women need a doctor too” Most women should be offered midwife-led models of care and women should be encouraged to ask for this option although caution should be exercised in applying this advice to women with substantial medical or obstetric complications.

Interpretation 11 trials, 12,000 women, 4 countries of midwife-led care in pregnancy and birth Limitatations Some effect sizes small Many secondary outcomes Confounders Midwife led unit setting & midwife led care Continuity & midwife led care Care pathways/protocols & midwife led care Cant generalise to Women with extensive medical complications Home birth Low income countries Lay/traditional midwives Midwife-led birth centres where antenatal care not provided

What do we need to find out? Outcomes of different models of continuity of care Impact of care pathways and clinical networks How should services be organised for women with substantial medical complications Impact of midwife continuity on perinatal morbidity and mortality Effects in middle and low incomes settings 35 35

Publications Sandall,J., Hatem.M., Devane,D., Soltani,H., Gates,S. (in submission) Implications of findings from a Cochrane Review of midwife-led versus other models of care for childbearing women in what works to improve ‘normal’ birth, Jnl Midwifery & Women’s Health Sandall,J., Hatem.M., Devane,D., Soltani,H., Gates,S. (2009) Discussion of findings from a Cochrane Review of midwife-led versus other models of care for childbearing women, Midwifery, 25, 8-13. Sandall J. (2008) Midwife-led versus other models of care for childbearing women:implications of findings from a Cochrane meta-analysis. Evidence Based Midwifery 6(4): 111. Hatem M, Sandall, J. Article most likely to change clinical practice” DynaMed Weekly Update 270109. Hatem M, Sandall, J. (Joint First Author and Contact Author) Devane D, Soltani H. Gates,S. (2008) Midwife-led versus other models of care for childbearing women, Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No: CD004667. Finlay,S. Sandall,J. (in press online ) “Someone’s rooting for you”: Continuity and Advocacy in Bureaucratic Maternal Health Care Systems, Social Science and Medicine, doi:10.1016/j.socscimed.2009.07.029 36 36