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1.  Women’s groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis 
Lancet  2013;381(9879):1736-1746.
Maternal and neonatal mortality rates remain high in many low-income and middle-income countries. Different approaches for the improvement of birth outcomes have been used in community-based interventions, with heterogeneous effects on survival. We assessed the effects of women’s groups practising participatory learning and action, compared with usual care, on birth outcomes in low-resource settings.
We did a systematic review and meta-analysis of randomised controlled trials undertaken in Bangladesh, India, Malawi, and Nepal in which the effects of women’s groups practising participatory learning and action were assessed to identify population-level predictors of effect on maternal mortality, neonatal mortality, and stillbirths. We also reviewed the cost-effectiveness of the women’s group intervention and estimated its potential effect at scale in Countdown countries.
Seven trials (119 428 births) met the inclusion criteria. Meta-analyses of all trials showed that exposure to women’s groups was associated with a 37% reduction in maternal mortality (odds ratio 0·63, 95% CI 0·32–0·94), a 23% reduction in neonatal mortality (0·77, 0·65–0·90), and a 9% non-significant reduction in stillbirths (0·91, 0·79–1·03), with high heterogeneity for maternal (I2=58·8%, p=0·024) and neonatal results (I2=64·7%, p=0·009). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0·026 and p=0·011, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 55% reduction in maternal mortality (0·45, 0·17–0·73) and a 33% reduction in neonatal mortality (0·67, 0·59–0·74). The intervention was cost effective by WHO standards and could save an estimated 283 000 newborn infants and 41 100 mothers per year if implemented in rural areas of 74 Countdown countries.
With the participation of at least a third of pregnant women and adequate population coverage, women’s groups practising participatory learning and action are a cost-effective strategy to improve maternal and neonatal survival in low-resource settings.
Wellcome Trust, Ammalife, and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Birmingham and the Black Country programme.
PMCID: PMC3797417  PMID: 23683640
2.  The effectiveness of exercise as a treatment for postnatal depression: study protocol 
Postnatal depression can have a substantial impact on the woman, the child and family as a whole. Thus, there is a need to examine different ways of helping women experiencing postnatal depression; encouraging them to exercise may be one way. A meta analysis found some support for exercise as an adjunctive treatment for postnatal depression but the methodological inadequacy of the few small studies included means that it is uncertain whether exercise reduces symptoms of postnatal depression. We aim to determine whether a pragmatic exercise intervention that involves one-to-one personalised exercise consultations and telephone support plus usual care in women with postnatal depression, is superior to usual care only, in reducing symptoms of postnatal depression.
We aim to recruit 208 women with postnatal depression in the West Midlands. Recently delivered women who meet the ICD-10 diagnosis for depression will be randomised to usual care plus exercise or usual care only. The exercise intervention will be delivered over 6 months. The primary outcome measure is difference in mean Edinburgh Postnatal Depression Scale score between the groups at six month follow-up. Outcome measures will be assessed at baseline and at six and 12 month post randomisation.
Findings from the research will inform future clinical guidance on antenatal and postnatal mental health, as well as inform practitioners working with postnatal depression.
Trial registration number
PMCID: PMC3449184  PMID: 22682671
Exercise; Postnatal depression
3.  Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS): a randomised controlled trial 
Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK).
The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW) service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT) in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service.
The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care) from randomisation (before 28 weeks gestation) until 6 weeks after birth.
The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy) and mother-to-infant bonding will also be collected using validated tools.
A sample size of 1316 will provide 90% power (at the 5% significance level) to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will be by intention to treat.
Qualitative research will explore the POWs' daily work in context. This will complement the findings of the RCT through a triangulation of quantitative and qualitative data on the process of the intervention, and identify other contextual factors that affect the implementation of the intervention.
The trial will provide high quality evidence as to whether or not lay support (POW) offered to women identified with social risk factors improves engagement with maternity services and reduces numbers of women with depression.
MREC number
Trial registration number
PMCID: PMC3349581  PMID: 22375895
4.  A comparison of clinical officers with medical doctors on outcomes of caesarean section in the developing world: meta-analysis of controlled studies 
Objective To review the effectiveness and safety of clinical officers (healthcare providers trained to perform tasks usually undertaken by doctors) carrying out caesarean section in developing countries compared with doctors.
Design Systematic review with meta-analysis.
Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, CINAHL, BioMed Central, the Reproductive Health Library, and the Science Citation Index (inception-2010) without language restriction.
Study selection Controlled studies.
Data extraction Information was extracted from each selected article on study characteristics, quality, and outcome data. Two independent reviewers extracted data.
Results Six non-randomised controlled studies (16 018 women) evaluated the effectiveness of clinical officers carrying out caesarean section. Meta-analysis found no significant differences between the clinical officers and doctors for maternal death (odds ratio 1.46, 95% confidence interval 0.78 to 2.75; P=0.24) or for perinatal death (1.31, 0.87 to 1.95; P=0.19). The results were heterogeneous, with some studies reporting a higher incidence of both outcomes with clinical officers. Clinical officers were associated with a higher incidence of wound infection (1.58, 1.01 to 2.47; P=0.05) and wound dehiscence (1.89, 1.21 to 2.95; P=0.005). Two studies accounted for confounding factors.
Conclusion Clinical officers and doctors did not differ significantly in key outcomes for caesarean section, but the conclusions are tentative owing to the non-randomised nature of the studies. The increase in wound infection and dehiscence may highlight a particular training need for clinical officers.
PMCID: PMC3272986  PMID: 21571914
5.  Heather Rosemary Winter 
BMJ : British Medical Journal  2008;336(7645):675.
PMCID: PMC2270951
6.  Effect of antenatal peer support on breastfeeding initiation: a systematic review 
Our objective was to examine the effect of antenatal peer support on rates of breastfeeding initiation.
We performed a systematic review of randomized controlled trials, quasi-randomized trials and cohort studies with concurrent controls. We searched the Cochrane Library, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the National Research Register and the British Nursing Index from inception or from 1980 to 2009. We carried out study selection, data abstraction and quality assessment independently and in duplicate. We defined high-quality studies as those that minimized the risk of at least three of the following types of bias: selection, performance, measurement and attrition bias. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for individual studies and undertook separate meta-analyses for high-quality trials of universal peer support and targeted peer support. We did not include low-quality studies.
We selected 11 studies, which involved 5445 women in total. Seven of these studies (involving 4416 women in total) evaluated universal peer support, and four studies (involving 1029 women in total) targeted antenatal peer support. In the three high-quality studies of universal peer support, all involving low-income women, the relative risk for not initiating breastfeeding was 0.96 (95% CI 0.76–1.22). In the three high-quality studies of antenatal peer support that targeted women considering breastfeeding, the relative risk for not initiating breastfeeding was 0.64 (95% CI 0.41 – 0.99).
Universal antenatal peer support does not appear to improve rates of breastfeeding initiation, but targeted antenatal peer support may be beneficial. This effect may be related to context, however, so any new peer-support program should undergo concurrent high-quality evaluation.
PMCID: PMC2972324  PMID: 20940234
7.  Feasibility of an exercise intervention for women with postnatal depression: a pilot randomised controlled trial 
Postnatal depression is a serious mental health problem that may be reduced by exercise.
This study examined the feasibility of an exercise intervention for women with postnatal depression, and assessed which methods of recruitment are most effective.
Design of study
Randomised controlled trial.
General practice and the community.
Participants were recruited from various sources and randomised to an exercise intervention or usual care with follow-up at 12 weeks. As well as assessing feasibility, other trial outcomes included exercise participation and self-efficacy for exercise. Levels of depression were assessed but the study was not powered to show a difference in this.
The recruitment rate of eligible patients was 23.1%. The highest recruitment rate was via referral from the psychiatric mother and baby unit (9/28; 32.1%), followed by invitation letters from GPs (24/93; 25.8%). Thirty-eight eligible participants were randomised. At follow-up there was no significant difference in exercise participation between groups. The intervention group reported significantly higher self-efficacy for exercise compared to usual care, but depression scores did not differ.
Exercise participation over the 12-week period was not significantly increased, possibly because it is difficult to motivate women with postnatal depression to exercise, or the intervention was not sufficiently intensive. Eligible patients were recruited into this study but response rates were low. Optimum methods of recruitment in this difficult-to-reach population are required prior to a substantive trial. Further research is imperative given poorly-evidenced recommendations by the National Institute for Health and Clinical Excellence to consider this treatment.
PMCID: PMC2249793  PMID: 18399022
exercise; postnatal depression; women
8.  Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial 
Objective To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding.
Design Cluster randomised controlled trial.
Setting Community antenatal clinics in one primary care trust in a multiethnic, deprived population.
Participants 66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care.
Intervention An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks’ gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population.
Main outcome measure Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered.
Results The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not.
Conclusion A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates.
Trial registration Current Controlled Trials ISRCTN16126175.
PMCID: PMC2636685  PMID: 19181730
9.  Systematic review of effect of community-level interventions to reduce maternal mortality 
The objective was to provide a systematic review of the effectiveness of community-level interventions to reduce maternal mortality.
We searched published papers using Medline, Embase, Cochrane library, CINAHL, BNI, CAB ABSTRACTS, IBSS, Web of Science, LILACS and African Index Medicus from inception or at least 1982 to June 2006; searched unpublished works using National Research Register website, metaRegister and the WHO International Trial Registry portal. We hand searched major references.
Selection criteria were maternity or childbearing age women, comparative study designs with concurrent controls, community-level interventions and maternal death as an outcome. We carried out study selection, data abstraction and quality assessment independently in duplicate.
We found five cluster randomised controlled trials (RCT) and eight cohort studies of community-level interventions. We summarised results as odds ratios (OR) and confidence intervals (CI), combined using the Peto method for meta-analysis. Two high quality cluster RCTs, aimed at improving perinatal care practices, showed a reduction in maternal mortality reaching statistical significance (OR 0.62, 95% CI 0.39 to 0.98). Three equivalence RCTs of minimal goal-oriented versus usual antenatal care showed no difference in maternal mortality (1.09, 95% CI 0.53 to 2.25). The cohort studies were of low quality and did not contribute further evidence.
Community-level interventions of improved perinatal care practices can bring about a reduction in maternal mortality. This challenges the view that investment in such interventions is not worthwhile. Programmes to improve maternal mortality should be evaluated using randomised controlled techniques to generate further evidence.
PMCID: PMC2637835  PMID: 19154588
10.  Exercise participation, body mass index, and health-related quality of life in women of menopausal age 
Menopausal symptoms can affect women's health and wellbeing. It is important to develop interventions to alleviate symptoms, especially given recent evidence resulting in many women no longer choosing to take hormone replacement therapy. Exercise may prove useful in alleviating symptoms, although evidence on its effectiveness has been conflicting.
To examine the association between exercise participation, body mass index (BMI), and health-related quality of life in women of menopausal-age.
Design of study
Survey of women of menopausal age.
West Midlands, England.
Women aged 46–55 years (n = 2399) registered with six general practices in the West Midlands were sent a questionnaire containing items relating to demographics, lifestyle factors, weight, height, exercise participation, menopausal bleeding patterns, and health-related quality of life (including vasomotor symptoms).
One thousand two hundred and six (50.3%) women replied. Women who were regularly active reported better health-related quality of life scores than women who were not regularly active (P<0.01 for all significant subscales). No difference in vasomotor symptoms was recorded for exercise status. Women who were obese reported significantly higher vasomotor symptom scores than women of normal weight (P<0.01). Women who were obese reported significantly higher somatic symptoms (P<0.001) and attractiveness concern scores (P<0.001) than women of normal weight or those who were overweight.
The data suggest a positive association between somatic and psychological dimensions of health-related quality of life and participation in regular exercise. Women with BMI scores in the normal range reported lower vasomotor symptom scores and better health-related quality of life scores than heavier women. Further evidence from high-quality randomised controlled trials is required to assess whether exercise interventions are effective for management of menopausal symptoms.
PMCID: PMC2034173  PMID: 17266830
body mass index; exercise; health-related quality of life; menopause
11.  Randomised controlled trial of conservative management of postnatal urinary and faecal incontinence: six year follow up 
BMJ : British Medical Journal  2005;330(7487):337.
Objective To determine the long term effects of a conservative nurse-led intervention for postnatal urinary incontinence.
Design Randomised controlled trial.
Setting Community based intervention in three centres in the United Kingdom and New Zealand.
Participants 747 women with urinary incontinence at three months after childbirth, of whom 516 were followed up again at 6 years (69%).
Intervention Active conservative treatment (pelvic floor muscle training and bladder training) at five, seven, and nine months after delivery or standard care.
Main outcome measures Urinary and faecal incontinence, performance of pelvic floor muscle training.
Results Of 2632 women with urinary incontinence, 747 participated in the original trial. The significant improvements relative to controls in urinary (60% v 69%) and faecal (4% v 11%) incontinence at one year were not found at six year follow up (76% v 79% (95% confidence interval for difference in means -10.2% to 4.1%) for urinary incontinence, 12% v 13% (-6.4% to 5.1%) for faecal incontinence) irrespective of subsequent obstetric events. In the short term the intervention had motivated more women to perform pelvic floor muscle training (83% v 55%) but this fell to 50% in both groups in the long term. Both urinary and faecal incontinence increased in prevalence in both groups during the study period.
Conclusions The moderate short term benefits of a brief nurse-led conservative treatment of postnatal urinary incontinence may not persist, even among women with no further deliveries. About three quarters of women with urinary incontinence three months after childbirth still have this six years later.
PMCID: PMC548727  PMID: 15615766
12.  Conservative management of persistent postnatal urinary and faecal incontinence: randomised controlled trial 
BMJ : British Medical Journal  2001;323(7313):593.
To assess the effect of nurse assessment with reinforcement of pelvic floor muscle training exercises and bladder training compared with standard management among women with persistent incontinence three months postnatally.
Randomised controlled trial with nine months' follow up.
Community intervention in three centres (Dunedin, New Zealand; Birmingham; Aberdeen).
747 women with urinary incontinence three months postnatally, allocated at random to intervention (371) or control (376) groups.
Assessment by nurses of urinary incontinence with conservative advice on pelvic floor exercises at five, seven, and nine months after delivery supplemented with bladder training if appropriate at seven and nine months.
Main outcome measures
Primary: persistence and severity of urinary incontinence 12 months after delivery. Secondary: performance of pelvic floor exercises, change in coexisting faecal incontinence, wellbeing, anxiety, and depression.
Women in the intervention group had significantly less urinary incontinence: 167/279 (59.9%) v 169/245 (69.0%), difference 9.1% (95% confidence interval 1.0% to 17.3%, P=0.037) for any incontinence and 55/279 (19.7%) v 78/245 (31.8%), difference 12.1% (4.7% to 19.6%, P=0.002) for severe incontinence. Faecal incontinence was also less common: 12/273 (4.4%) v 25/237 (10.5%), difference 6.1% (1.6% to 10.8%, P=0.012). At 12 months women in the intervention group were more likely to be performing pelvic floor exercises (218/278 (79%) v 118/244 (48%), P<0.001).
A third of women may have some urinary incontinence three months after childbirth. Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum. Further trials for faecal incontinence are needed.
What is already known on this topicVaginal delivery is a risk factor for urinary incontinenceThree months after childbirth 20-30% of women still experience urinary incontinenceMost women do not seek treatmentWhat this study addsWomen will use conservative treatments such as pelvic floor exercises or bladder trainingConservative management prevents persistent urinary incontinence in about one in 10 women who have postnatal incontinenceCoexisting persistent faecal incontinence is also improved
PMCID: PMC55571  PMID: 11557703
13.  Delay in the diagnosis of colorectal cancer 
Investigation of factors affecting the speed of diagnosis, referral and treatment of 113 patients with colorectal cancer shows that failure to examine the patient was significantly associated with delay. Patients who were not given a rectal or abdominal examination at their first medical consultation experienced considerably more delay in being referred for specialist opinion. Factors affecting the decision to examine are described.
PMCID: PMC1972713  PMID: 6842437
14.  Effectiveness of strategies incorporating training and support of traditional birth attendants on perinatal and maternal mortality: meta-analysis 
Objective To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries.
Design Systematic review with meta-analysis.
Data sources Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were “birth attend*”, “traditional midwife”, “lay birth attendant”, “dais”, and “comadronas”.
Review methods We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model.
Results We identified six cluster randomised controlled trials (n=138 549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, P<0.001; number needed to treat 35, 24 to 70) and neonatal death (0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170). Meta-analysis of the non-randomised studies also showed a significant reduction in perinatal mortality (0.70, 0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal mortality (0.61, 0.48 to 0.75, P<0.001; 96, 65 to 168). Six studies reported on maternal mortality and our meta-analysis showed a non-significant reduction (three randomised trials, relative risk 0.79, 0.53 to 1.05, P=0.12; three non-randomised studies, 0.80, 0.44 to 1.15, P=0.26).
Conclusion Perinatal and neonatal deaths are significantly reduced with strategies incorporating training and support of traditional birth attendants.
PMCID: PMC3228291  PMID: 22134967

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