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1.  Management of pregnant and postnatal women with pre-existing diabetes or cardiac disease using multi-disciplinary team models of care: a systematic review 
More women with an increased risk of poor pregnancy outcome due to pre-existing medical conditions are becoming pregnant. Although clinical care provided through multi-disciplinary team (MDT) working is recommended, little is known about the structure or working practices of different MDT models, their impact on maternal and infant outcomes or healthcare resources. The objectives of this review were to consider relevant international evidence to determine the most appropriate MDT models of care to manage complex medical conditions during and after pregnancy, with a specific focus on pre-existing diabetes or cardiac disease in high income country settings.
Quantitative and qualitative evidence of MDT models of care for the management of pregnant/postnatal women with pre-existing diabetes and cardiac disease was considered. A search of the literature published between January 2002 - January 2014 was undertaken. Methodological quality was assessed using checklists developed by the Joanna Briggs Institute. Given limited primary and secondary research evidence, guidelines and opinion papers were included. Two independent reviewers conducted critical appraisal of included papers.
Nineteen papers were included from UK, Canada, USA, the Netherlands and Singapore. No studies were found which had compared MDT models for pregnant/postnatal women with pre-existing diabetes or cardiac disease. Two small retrospective studies reported better outcomes for women with cardiac disease if an MDT approach was used, although evidence to support this was limited. Due to study heterogeneity it was not possible to meta-analyse data. No evidence was identified of MDT management in the postnatal period or impacts of MDT working on healthcare resources.
Despite widespread promotion of MDT models of care for pregnant and postnatal women with pre-existing diabetes or cardiac disease, there is a dearth of primary evidence to inform structure or working practices or beneficial impact on maternal and infant outcomes or healthcare resources. Primary research into if or how MDT models of care improve outcomes for women with complex pregnancies is urgently needed.
Electronic supplementary material
The online version of this article (doi:10.1186/s12884-014-0428-5) contains supplementary material, which is available to authorized users.
PMCID: PMC4296678  PMID: 25528045
Multidisciplinary team; Pregnancy; Diabetes; Cardiac disease; Maternity; Antenatal; Postnatal; Complex pregnancies
2.  The relationship between severe maternal morbidity and psychological health symptoms at 6–8 weeks postpartum: a prospective cohort study in one English maternity unit 
The incidence of severe maternal morbidity is increasing in high-income countries. However, little has been known about the impact on postnatal morbidity, particularly on psychological health outcomes. The objective of this study was to assess the relationship between severe maternal morbidity (ie. major obstetric haemorrhage, severe hypertensive disorders or intensive care unit/obstetric high dependency unit admission) and postnatal psychological health symptoms, focusing on post-traumatic stress disorder (PTSD) symptoms at 6–8 weeks postpartum.
A prospective cohort study was undertaken of women who gave birth over six months in 2010 in an inner city maternity unit in England. Primary outcomes were prevalence of PTSD symptoms namely: 1) intrusion and 2) avoidance as measured using the Impact of Event Scale at 6 – 8 weeks postpartum via a self-administered postal questionnaire. Secondary outcomes included probable depression. Data on incidence of severe maternal morbidity were extracted from maternity records. Multivariable logistic regression analysis examined the relationship between severe maternal morbidity and PTSD symptoms taking into account factors that might influence the relationship.
Of women eligible to participate (n=3509), 52% responded. Prevalence of a clinically significant level of intrusion and avoidance were 6.4% (n=114) and 8.4% (n=150) respectively. There was a higher risk of PTSD symptoms among women who experienced severe maternal morbidity compared with women who did not (adjusted OR = 2.11, 95%CI = 1.17-3.78 for intrusion; adjusted OR = 3.28, 95%CI = 2.01-5.36 for avoidance). Higher ratings of reported sense of control during labour/birth partially mediated the risk of PTSD symptoms. There were no statistically significant differences in the prevalence or severity of symptoms of depression.
This is one of the largest studies to date of PTSD symptoms among women who had recently given birth. Findings showed that an experience of severe maternal morbidity was independently associated with symptoms of PTSD. Individually tailored care that increases women’s sense of control during labour may be a protective factor with further work required to promote effective interventions to prevent these symptoms. Findings have important implications for women’s health and the content and organisation of maternity services during and after the birth.
PMCID: PMC4021064  PMID: 24708797
Stress disorders; Post-traumatic; Pregnancy complications; Puerperal disorders; Postnatal care; Cohort studies
3.  Effects of demand-side financing on utilisation, experiences and outcomes of maternity care in low- and middle-income countries: a systematic review 
Demand-side financing, where funds for specific services are channelled through, or to, prospective users, is now employed in health and education sectors in many low- and middle-income countries. This systematic review aimed to critically examine the evidence on application of this approach to promote maternal health in these settings. Five modes were considered: unconditional cash transfers, conditional cash transfers, short-term payments to offset costs of accessing maternity services, vouchers for maternity services, and vouchers for merit goods. We sought to assess the effects of these interventions on utilisation of maternity services and on maternal health outcomes and infant health, the situation of underprivileged women and the healthcare system.
The protocol aimed for collection and synthesis of a broad range of evidence from quantitative, qualitative and economic studies. Nineteen health and social policy databases, seven unpublished research databases and 27 websites were searched; with additional searches of Indian journals and websites. Studies were included if they examined demand-side financing interventions to increase consumption of services or goods intended to impact on maternal health, and met relevant quality criteria. Quality assessment, data extraction and analysis used Joanna Briggs Institute standardised tools and software. Outcomes of interest included maternal and infant mortality and morbidity, service utilisation, factors required for successful implementation, recipient and provider experiences, ethical issues, and cost-effectiveness. Findings on Effectiveness, Feasibility, Appropriateness and Meaningfulness were presented by narrative synthesis.
Thirty-three quantitative studies, 46 qualitative studies, and four economic studies from 17 countries met the inclusion criteria. Evidence on unconditional cash transfers was scanty. Other demand-side financing modes were found to increase utilisation of maternal healthcare in the index pregnancy or uptake of related merit goods. Evidence of effects on maternal and infant mortality and morbidity outcomes was insufficient. Important implementation aspects include targeting and eligibility criteria, monitoring, respectful treatment of beneficiaries, suitable incentives for providers, quality of care and affordable referral systems.
Demand-side financing schemes can increase utilisation of maternity services, but attention must be paid to supply-side conditions, the fine-grain of implementation and sustainability. Comparative studies and research on health impact and cost-effectiveness are required.
PMCID: PMC3897964  PMID: 24438560
Demand-side financing; Maternal health; Vouchers; Cash transfers; Narrative synthesis; Qualitative; Systematic review
4.  Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial 
BMC Medicine  2013;11:209.
Perineal trauma during childbirth affects millions of women worldwide every year. The aim of the Perineal Assessment and Repair Longitudinal Study (PEARLS) was to improve maternal clinical outcomes following childbirth through an enhanced cascaded multiprofessional training program to support implementation of evidence-based perineal management.
This was a pragmatic matched-pair cluster randomized controlled trial (RCT) that enrolled women (n = 3681) sustaining a second-degree perineal tear in one of 22 UK maternity units (clusters), organized in 11 matched pairs. Units in each matched pair were randomized to receive the training intervention either early (group A) or late (group B). Outcomes within each cluster were assessed prior to any training intervention (phase 1), and then after the training intervention was given to group A (phase 2) and group B (phase 3). Focusing on phase 2, the primary outcome was the percentage of women who had pain on sitting or walking at 10 to 12 days post-natal. Secondary outcomes included use of pain relief at 10 to 12 days post-natal, need for suture removal, uptake and duration of exclusive breastfeeding, and perineal wound infection. Practice-based measures included implementation of evidence into practice to promote effective clinical management of perineal trauma. Cluster-level paired t-tests were used to compare groups A and B.
There was no significant difference between the clusters in phase 2 of the study in the average percentage of women reporting perineal pain on sitting and walking at 10 to 12 days (mean difference 0.7%; 95% CI −10.1% to 11.4%; P = 0.89). The intervention significantly improved overall use of evidence-based practice in the clinical management of perineal trauma. Following the training intervention, group A clusters had a significant reduction in mean percentages of women reporting perineal wound infections and of women needing sutures removed.
PEARLS is the first RCT to assess the effects of a ‘training package on implementation of evidence-based perineal trauma management. The intervention did not significantly improve the primary outcome but did significantly improve evidence-based practice and some of the relevant secondary clinical outcomes for women.
Trial registrations
NIHR UKCRN portfolio no: 4785.
PMCID: PMC3849411  PMID: 24059602
Childbirth; Perineum; Trauma; Cluster RCT; Quality improvement
5.  A systematic review of the relationship between severe maternal morbidity and post-traumatic stress disorder 
The incidence of severe maternal morbidity is increasing in high-income countries as a consequence, in part, of increased obstetric intervention and increasingly complex medical needs of women who become pregnant. Access to emergency obstetric care means that for the majority of women in these countries, an experience of severe maternal morbidity is unlikely to result in loss of life. However, little is known about the subsequent impact on postnatal psychological health resulting in an evidence gap to support provision of appropriate care for these women. There has recently been increasing recognition that childbirth can be a cause of post-traumatic stress disorder (PTSD). The combination of experiencing a life-threatening complication and its management may culminate in psychological trauma. This systematic review examined the association between women’s experience of severe maternal morbidity during labour, at the time of giving birth or within the first week following birth, and PTSD and its symptoms.
Relevant literature was identified through multiple databases, including MEDLINE, PsycINFO, EMBASE, CINAHL, British Nursing Index, Web of Science, Cochrane library and the British Library, using predetermined search strategies. The search terms included "post-traumatic stress disorder", "PTSD", "stress disorders, post-traumatic", "maternal morbidity", “pregnancy complications” “puerperal disorders”, "obstetric labo(u)r complication", "postpartum h(a)emorrhage", "eclampsia”. Studies identified were categorised according to pre-defined inclusion and exclusion criteria. The quality of included studies was assessed using the relevant CASP appraisal tools.
Eleven primary studies met review criteria. Evidence of a relationship between severe maternal morbidity and PTSD/PTSD symptoms was inconsistent and findings varied between studies. Nevertheless, there is some evidence that severe pre-eclampsia is a risk factor for PTSD and its symptoms, an association possibly mediated by other factors such as fetal/neonatal condition.
Despite the absence of robust evidence regarding the relationship between severe maternal morbidity and PTSD/PTSD symptoms, it is crucially important that clinicians and policy makers are aware of a potential higher risk of PTSD among women who experience severe morbidity. Further studies are now needed to confirm this risk as well as to understand underlying mechanisms in order to minimise the longer term psychiatric impact of severe maternal morbidity.
PMCID: PMC3582425  PMID: 23140343
PTSD; Childbirth; Posttraumatic stress; Obstetric labor complication; Pregnancy complications; Puerperal disorders
6.  How good are we at implementing evidence to support the management of birth related perineal trauma? A UK wide survey of midwifery practice 
The accurate assessment and appropriate repair of birth related perineal trauma require high levels of skill and competency, with evidence based guideline recommendations available to inform UK midwifery practice. Implementation of guideline recommendations could reduce maternal morbidity associated with perineal trauma, which is commonly reported and persistent, with potential to deter women from a future vaginal birth. Despite evidence, limited attention is paid to this important aspect of midwifery practice. We wished to identify how midwives in the UK assessed and repaired perineal trauma and the extent to which practice reflected evidence based guidance. Findings would be used to inform the content of a large intervention study.
A descriptive cross sectional study was completed. One thousand randomly selected midwives were accessed via the Royal College of Midwives (RCM) and sent a questionnaire. Study inclusion criteria included that the midwives were in clinical practice and undertook perineal assessment and management within their current role. Quantitative and qualitative data were collated. Associations between midwife characteristics and implementation of evidence based recommendations for perineal assessment and management were examined using chi-square tests of association.
405 midwives (40.5%) returned a questionnaire, 338 (83.5%) of whom met inclusion criteria. The majority worked in a consultant led unit (235, 69.5%) and over a third had been qualified for 20 years or longer (129, 38.2%). Compliance with evidence was poor. Few (6%) midwives used evidence based suturing methods to repair all layers of perineal trauma and only 58 (17.3%) performed rectal examination as part of routine perineal trauma assessment. Over half (192, 58.0%) did not suture all second degree tears. Feeling confident to assess perineal trauma all of the time was only reported by 116 (34.3%) midwives, with even fewer (73, 21.6%) feeling confident to perform perineal repair all of the time. Two thirds of midwives (63.5%) felt confident to perform an episiotomy. Midwives qualified for 20 years or longer and those on more senior clinical grades were most likely to implement evidence based recommendations and feel confident about perineal management.
There are considerable gaps with implementation of evidence to support management of perineal trauma.
PMCID: PMC3472238  PMID: 22731799
Perineal trauma; Episiotomy; Suturing methods; Maternal morbidity; Midwifery practice
7.  Revising acute care systems and processes to improve breastfeeding and maternal postnatal health: a pre and post intervention study in one English maternity unit 
Most women in the UK give birth in a hospital labour ward, following which they are transferred to a postnatal ward and discharged home within 24 to 48 hours of the birth. Despite policy and guideline recommendations to support planned, effective postnatal care, national surveys of women’s views of maternity care have consistently found in-patient postnatal care, including support for breastfeeding, is poorly rated.
Using a Continuous Quality Improvement approach, routine antenatal, intrapartum and postnatal care systems and processes were revised to support implementation of evidence based postnatal practice. To identify if implementation of a multi-faceted QI intervention impacted on outcomes, data on breastfeeding initiation and duration, maternal health and women’s views of care, were collected in a pre and post intervention longitudinal survey. Primary outcomes included initiation, overall duration and duration of exclusive breastfeeding. Secondary outcomes included maternal morbidity, experiences and satisfaction with care. As most outcomes of interest were measured on a nominal scale, these were compared pre and post intervention using logistic regression.
Data were obtained on 741/1160 (64%) women at 10 days post-birth and 616 (54%) at 3 months post-birth pre-intervention, and 725/1153 (63%) and 575 (50%) respectively post-intervention. Post intervention there were statistically significant differences in the initiation (p = 0.050), duration of any breastfeeding (p = 0.020) and duration of exclusive breastfeeding to 10 days (p = 0.038) and duration of any breastfeeding to three months (p = 0.016). Post intervention, women were less likely to report physical morbidity within the first 10 days of birth, and were more positive about their in-patient care.
It is possible to improve outcomes of routine in-patient care within current resources through continuous quality improvement.
PMCID: PMC3489602  PMID: 22672354
8.  Improving inpatient postnatal services: midwives views and perspectives of engagement in a quality improvement initiative 
Despite major policy initiatives in the United Kingdom to enhance women's experiences of maternity care, improving in-patient postnatal care remains a low priority, although it is an aspect of care consistently rated as poor by women. As part of a systems and process approach to improving care at one maternity unit in the South of England, the views and perspectives of midwives responsible for implementing change were sought.
A Continuous Quality Improvement (CQI) approach was adopted to support a systems and process change to in-patient care and care on transfer home in a large district general hospital with around 6000 births a year. The CQI approach included an initial assessment to identify where revisions to routine systems and processes were required, developing, implementing and evaluating revisions to the content and documentation of care in hospital and on transfer home, and training workshops for midwives and other maternity staff responsible for implementing changes. To assess midwifery views of the quality improvement process and their engagement with this, questionnaires were sent to those who had participated at the outset.
Questionnaires were received from 68 (46%) of the estimated 149 midwives eligible to complete the questionnaire. All midwives were aware of the revisions introduced, and two-thirds felt these were more appropriate to meet the women's physical and emotional health, information and support needs. Some midwives considered that the introduction of new maternal postnatal records increased their workload, mainly as a consequence of colleagues not completing documentation as required.
This was the first UK study to undertake a review of in-patient postnatal services. Involvement of midwives at the outset was essential to the success of the initiative. Midwives play a lead role in the planning and organisation of in-patient postnatal care and it was important to obtain their feedback on whether revisions were pragmatic and achieved anticipated improvements in care quality. Their initial involvement ensured priority areas for change were identified and implemented. Their subsequent feedback highlighted further important areas to address as part of CQI to ensure best quality care continues to be implemented. Our findings could support other maternity service organisations to optimise in-patient postnatal services.
PMCID: PMC3215185  PMID: 22044744
9.  A qualitative study of the experiences and expectations of women receiving in-patient postnatal care in one English maternity unit 
Studies consistently highlight in-patient postnatal care as the area of maternity care women are least satisfied with. As part of a quality improvement study to promote a continuum of care from the birthing room to discharge home from hospital, we explored women's expectations and experiences of current in-patient care.
For this part of the study, qualitative data from semi-structured interviews were transcribed and analysed using content analyses to identify issues and concepts. Women were recruited from two postnatal wards in one large maternity unit in the South of England, with around 6,000 births a year.
Twenty women, who had a vaginal or caesarean birth, were interviewed on the postnatal ward. Identified themes included; the impact of the ward environment; the impact of the attitude of staff; quality and level of support for breastfeeding; unmet information needs; and women's low expectations of hospital based postnatal care. Findings informed revision to the content and planning of in-patient postnatal care, results of which will be reported elsewhere.
Women's responses highlighted several areas where changes could be implemented. Staff should be aware that how they inter-act with women could make a difference to care as a positive or negative experience. The lack of support and inconsistent advice on breastfeeding highlights that units need to consider how individual staff communicate information to women. Units need to address how and when information on practical aspects of infant care is provided if women and their partners are to feel confident on the woman's transfer home from hospital.
PMCID: PMC2978124  PMID: 20979605
10.  A realistic evaluation: the case of protocol-based care 
'Protocol based care' was envisioned by policy makers as a mechanism for delivering on the service improvement agenda in England. Realistic evaluation is an increasingly popular approach, but few published examples exist, particularly in implementation research. To fill this gap, within this paper we describe the application of a realistic evaluation approach to the study of protocol-based care, whilst sharing findings of relevance about standardising care through the use of protocols, guidelines, and pathways.
Situated between positivism and relativism, realistic evaluation is concerned with the identification of underlying causal mechanisms, how they work, and under what conditions. Fundamentally it focuses attention on finding out what works, for whom, how, and in what circumstances.
In this research, we were interested in understanding the relationships between the type and nature of particular approaches to protocol-based care (mechanisms), within different clinical settings (context), and what impacts this resulted in (outcomes). An evidence review using the principles of realist synthesis resulted in a number of propositions, i.e., context, mechanism, and outcome threads (CMOs). These propositions were then 'tested' through multiple case studies, using multiple methods including non-participant observation, interviews, and document analysis through an iterative analysis process. The initial propositions (conjectured CMOs) only partially corresponded to the findings that emerged during analysis. From the iterative analysis process of scrutinising mechanisms, context, and outcomes we were able to draw out some theoretically generalisable features about what works, for whom, how, and what circumstances in relation to the use of standardised care approaches (refined CMOs).
As one of the first studies to apply realistic evaluation in implementation research, it was a good fit, particularly given the growing emphasis on understanding how context influences evidence-based practice. The strengths and limitations of the approach are considered, including how to operationalise it and some of the challenges. This approach provided a useful interpretive framework with which to make sense of the multiple factors that were simultaneously at play and being observed through various data sources, and for developing explanatory theory about using standardised care approaches in practice.
PMCID: PMC2889857  PMID: 20504293
11.  PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial 
The Perineal Assessment and Repair Longitudinal Study (PEARLS) is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women.
PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere) and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh Postnatal Depression Scale (EPDS) will be assessed at 10 days and three months post-birth.
Implementation of evidence-based perineal assessment and management practices, could lead to significantly improved physical and psychological health outcomes for women in the UK and world-wide.
Trial registration
PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.
PMCID: PMC2836981  PMID: 20184764
12.  A case study evaluation of implementation of a care pathway to support normal birth in one English birth centre: anticipated benefits and unintended consequences 
The policy drive for the UK National Health Service (NHS) has focused on the need for high quality services informed by evidence of best practice. The introduction of care pathways and protocols to standardise care and support implementation of evidence into practice has taken place across the NHS with limited evaluation of their impact. A multi-site case study evaluation was undertaken to assess the impact of use of care pathways and protocols on clinicians, service users and service delivery. One of the five sites was a midwifery-led Birth Centre, where an adapted version of the All Wales Clinical Pathway for Normal Birth had been implemented.
The overarching framework was realistic evaluation. A case study design enabled the capture of data on use of the pathway in the clinical setting, use of multiple methods of data collection and opportunity to study and understand the experiences of clinicians and service users whose care was informed by the pathway. Women attending the Birth Centre were recruited at their 36 week antenatal visit. Episodes of care during labour were observed, following which the woman and the midwife who cared for her were interviewed about use of the pathway. Interviews were also held with other key stakeholders from the study site. Qualitative data were content analysed.
Observations were undertaken of four women during labour. Eighteen interviews were conducted with clinicians and women, including the women whose care was observed and the midwives who cared for them, senior midwifery managers and obstetricians. The implementation of the pathway resulted in a number of anticipated benefits, including increased midwifery confidence in skills to support normal birth and promotion of team working. There were also unintended consequences, including concerns about a lack of documentation of labour care and negative impact on working relationships with obstetric and other midwifery colleagues. Women were unaware their care was informed by a care pathway.
Care pathways are complex interventions which generate a number of consequences for practice. Those considering introduction of pathways need to ensure all relevant stakeholders are engaged with this and develop robust evaluation strategies to accompany implementation.
PMCID: PMC2761848  PMID: 19804624
13.  Achieving sustainable quality in maternity services – using audit of incontinence and dyspareunia to identify shortfalls in meeting standards 
Some complications of childbirth (for example, faecal incontinence) are a source of social embarrassment for women, and are often under reported. Therefore, it was felt important to determine levels of complications (against established standards) and to consider obstetric measures aimed at reducing them.
Clinical information was collected on 1036 primiparous women delivering at North and South Staffordshire Acute and Community Trusts over a 5-month period in 1997. A questionnaire was sent to 970 women which included self-assessment of levels of incontinence and dyspareunia prior to pregnancy, at 6 weeks post delivery and 9 to 14 months post delivery.
The response rate was 48%(470/970). Relatively high levels of obstetric interventions were found. In addition, the rates of instrumental deliveries differed between the two hospitals. The highest rates of postnatal symptoms had occurred at 6 weeks, but for many women problems were still present at the time of the survey. At 9–14 months high rates of dyspareunia (29%(102/347)) and urinary incontinence (35%(133/382)) were reported. Seventeen women (4%) complained of faecal incontinence at this time. Similar rates of urinary incontinence and dyspareunia were seen regardless of mode of delivery.
Further work should be undertaken to reduce the obstetric interventions, especially instrumental deliveries. Improvements in a number of areas of care should be undertaken, including improved patient information, improved professional communication and improved professional recognition and management of third degree tears. It is likely that these measures would lead to a reduction in incontinence and dyspareunia after childbirth.
PMCID: PMC59837  PMID: 11710963

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