WITHDRAWN: Periconceptional supplementation with folate and/or multivitamins for preventing neural tube defects.

BACKGROUND: Neural tube defects arise during the development of the brain and spinal cord. OBJECTIVES: The objective of this review was to assess the effects of increased consumption of folate or multivitamins on the prevalence of neural tube defects periconceptionally (that is before pregnancy and in the first two months of pregnancy). SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. Date of last search: April 2001. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing periconceptional supplementation by multivitamins with placebo, folate with placebo, or multivitamins with folate; different dosages of multivitamins or folate; prepregnancy dietary advice and counselling in primary care settings to increase the consumption of folate-rich foods, or folate-fortified foods, with standard care; increased intensity of information provision with standard public health dissemination. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data. MAIN RESULTS: Four trials of supplementation involving 6425 women were included. The trials all addressed the question of supplementation and they were of variable quality. Periconceptional folate supplementation reduced the incidence of neural tube defects (relative risk 0.28, 95% confidence interval 0.13 to 0.58). Folate supplementation did not significantly increase miscarriage, ectopic pregnancy or stillbirth, although there was a possible increase in multiple gestation. Multivitamins alone were not associated with prevention of neural tube defects and did not produce additional preventive effects when given with folate.One dissemination trial, a community randomised trial, was identified involving six communities, matched in pairs, and where 1206 women of child-bearing age were interviewed following the dissemination intervention. This showed that the provision of printed material increased the awareness of the folate/neural tube defects association by 4%, (odds ratio 1.37, 95% confidence interval 1.33 to 1.42). AUTHORS' CONCLUSIONS: Periconceptional folate supplementation has a strong protective effect against neural tube defects. Information about folate should be made more widely available throughout the health and education systems. Women whose fetuses or babies have neural tube defects should be advised of the risk of recurrence in a subsequent pregnancy and offered continuing folate supplementation. The benefits and risks of fortifying basic food stuffs, such as flour, with added folate remain unresolved.

Mothers' AdvocateS In the Community (MOSAIC)--non-professional mentor support to reduce intimate partner violence and depression in mothers: a cluster randomised trial in primary care.

BACKGROUND: Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV) are scarce. As much attention is focussed on professional intervention, this study aimed to determine the effectiveness of non-professional mentor support in reducing IPV and depression among pregnant and recent mothers experiencing, or at risk of IPV. METHODS: MOSAIC was a cluster randomised trial in 106 primary care (maternal and child health nurse and general practitioner) clinics in Melbourne, Australia. 63/106 clinics referred 215 eligible culturally and linguistically diverse women between January 2006 and December 2007. 167 in the intervention (I) arm, and 91 in the comparison (C) arm. 174 (80.9%) were recruited. 133 (76.4%) women (90 I and 43 C) completed follow-up at 12 months. INTERVENTION: 12 months of weekly home visiting from trained and supervised local mothers, (English & Vietnamese speaking) offering non-professional befriending, advocacy, parenting support and referrals. MAIN OUTCOME MEASURES: Primary outcomes; IPV (Composite Abuse Scale CAS) and depression (Edinburgh Postnatal Depression Scale EPDS); secondary measures included wellbeing (SF-36), parenting stress (PSI-SF) and social support (MOS-SF) at baseline and follow-up. ANALYSIS: Intention-to-treat using multivariable logistic regression and propensity scoring. RESULTS: There was evidence of a true difference in mean abuse scores at follow-up in the intervention compared with the comparison arm (15.9 vs 21.8, AdjDiff -8.67, CI -16.2 to -1.15). There was weak evidence for other outcomes, but a trend was evident favouring the intervention: proportions of women with CAS scores ≥ 7, 51/88 (58.4%) vs 27/42 (64.3%) AdjOR 0.47, CI 0.21 to 1.05); depression (EPDS score ≥ 13) (19/85, 22% (I) vs 14/43, 33% (C); AdjOR 0.42, CI 0.17 to 1.06); physical wellbeing mean scores (PCS-SF36: AdjDiff 2.79; CI -0.40 to 5.99); mental wellbeing mean scores (MCS-SF36: AdjDiff 2.26; CI -1.48 to 6.00). There was no observed effect on parenting stress. 82% of women mentored would recommend mentors to friends in similar situations. CONCLUSION: Non-professional mentor mother support appears promising for improving safety and enhancing physical and mental wellbeing among mothers experiencing intimate partner violence referred from primary care. TRIAL REGISTRATION: ACTRN12607000010493http://www.anzctr.org.au.

Modelling prior reproductive history to improve prediction of risk for very preterm birth.

In published studies of preterm birth, analyses have usually been centred on individual reproductive events and do not account for the joint distributions of these events. In particular, spontaneous and induced abortions have often been studied separately and have been variously reported as having no increased risk, increased risk or different risks for subsequent preterm birth. In order to address this inconsistency, we categorised women into mutually exclusive groups according to their reproductive history, and explored the range of risks associated with different reproductive histories and assessed similarities of risks between different pregnancy histories. The data were from a population-based case-control study, conducted in Victoria, Australia. The study recruited women giving birth between April 2002 and April 2004 from 73 maternity hospitals. Detailed reproductive histories were collected by interview a few weeks after the birth. The cases were 603 women who had had a singleton birth between 20 and less than 32 weeks gestation (very preterm births including terminations of pregnancy) and the controls were 796 randomly selected women from the population who had had a singleton birth of at least 37 completed weeks gestation. All birth outcomes were included. Unconditional logistic regression was used to assess the association of very preterm birth with type and number of prior abortions, prior preterm births and sociodemographic factors. Using the complex combinations of prior pregnancy experiences of women (including nulligravidity), we showed that a history of prior childbirth (at term) with no preterm births gave the lowest risk of very preterm birth. With this group as the reference category, odds ratios of more than two were associated with all other prior reproductive histories. There was no evidence of difference in risk between types of abortion (i.e. spontaneous or induced) although the risk increased if a prior preterm birth had also occurred. There was an increasing risk of very preterm birth associated with increasing numbers of abortions. This method of data analysis reveals consistent and similar risks for very preterm birth following spontaneous or induced abortions. The findings point to the need to explore commonalities rather than differences in regard to the impact of abortion on subsequent births.

Modelling sequence of prior pregnancies on subsequent risk of very preterm birth.

The prevalence and intractability of preterm birth is known as is its association with reproductive history, but the relationship with sequence of pregnancies is not well studied. The data were from a population-based case-control study, conducted in Victoria, Australia. The study recruited women giving birth between April 2002 and April 2004 from 73 maternity hospitals. Detailed reproductive histories were collected by interview a few weeks after the birth. The cases were 603 women having a singleton birth between 20 and <32 weeks gestation (very preterm births including terminations of pregnancy). The controls were 796 randomly selected women from the population having a singleton birth of at least 37 completed weeks gestation. Unconditional logistic regression was used to assess the association of very preterm birth with sequence of pregnancies defined by their outcome (prior abortion - spontaneous or induced, and prior preterm or term birth) with adjustment for sociodemographic factors. The outcomes of each prior pregnancy, stratified by pregnancy order, and starting with the pregnancy immediately before the index or control pregnancy, were categorised as one of abortion, preterm birth or term birth. We showed that each of these prior pregnancy events was an independent risk of very preterm birth. This finding does not support the hypothesis of a neutralising effect of a term birth after an abortion on the subsequent risk for very preterm birth and is further evidence for the cumulative or increasing risk associated with increasing numbers of prior abortions or preterm births.

Interventions for promoting smoking cessation during pregnancy.

BACKGROUND: Tobacco smoking in pregnancy remains one of the few preventable factors associated with complications in pregnancy, low birthweight, preterm birth and has serious long-term health implications for women and babies. Smoking in pregnancy is decreasing in high-income countries and increasing in low- to middle-income countries and is strongly associated with poverty, low educational attainment, poor social support and psychological illness. OBJECTIVES: To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2008), the Cochrane Tobacco Addiction Group's Trials Register (June 2008), EMBASE, PsycLIT, and CINAHL (all from January 2003 to June 2008). We contacted trial authors to locate additional unpublished data. SELECTION CRITERIA: Randomised controlled trials where smoking cessation during pregnancy was a primary aim of the intervention. DATA COLLECTION AND ANALYSIS: Trials were identified and data extracted by one person and checked by a second. Subgroup analysis was conducted to assess the effect of risk of trial bias, intensity of the intervention and main intervention strategy used. MAIN RESULTS: Seventy-two trials are included. Fifty-six randomised controlled trials (over 20,000 pregnant women) and nine cluster-randomised trials (over 5000 pregnant women) provided data on smoking cessation outcomes.There was a significant reduction in smoking in late pregnancy following interventions (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.93 to 0.96), an absolute difference of six in 100 women who stopped smoking during pregnancy. However, there is significant heterogeneity in the combined data (I(2) > 60%). In the trials with the lowest risk of bias, the interventions had less effect (RR 0.97, 95% CI 0.94 to 0.99), and lower heterogeneity (I(2) = 36%). Eight trials of smoking relapse prevention (over 1000 women) showed no statistically significant reduction in relapse.Smoking cessation interventions reduced low birthweight (RR 0.83, 95% CI 0.73 to 0.95) and preterm birth (RR 0.86, 95% CI 0.74 to 0.98), and there was a 53.91g (95% CI 10.44 g to 95.38 g) increase in mean birthweight. There were no statistically significant differences in neonatal intensive care unit admissions, very low birthweight, stillbirths, perinatal or neonatal mortality but these analyses had very limited power. AUTHORS' CONCLUSIONS: Smoking cessation interventions in pregnancy reduce the proportion of women who continue to smoke in late pregnancy, and reduce low birthweight and preterm birth. Smoking cessation interventions in pregnancy need to be implemented in all maternity care settings. Given the difficulty many pregnant women addicted to tobacco have quitting during pregnancy, population-based measures to reduce smoking and social inequalities should be supported.

MOSAIC (MOthers' Advocates In the Community): protocol and sample description of a cluster randomised trial of mentor mother support to reduce intimate partner violence among pregnant or recent mothers.

BACKGROUND: Intimate partner violence (IPV) is prevalent globally, experienced by a significant minority of women in the early childbearing years and is harmful to the mental and physical health of women and children. There are very few studies with rigorous designs which have tested the effectiveness of IPV interventions to improve the health and wellbeing of abused women. Evidence for the separate benefit to victims of social support, advocacy and non-professional mentoring suggested that a combined model may reduce the levels of violence, the associated mental health damage and may increase a woman's health, safety and connection with her children. This paper describes the development, design and implementation of a trial of mentor mother support set in primary care, including baseline characteristics of participating women. METHODS/DESIGN: MOSAIC (MOtherS' Advocates In the Community) was a cluster randomised trial embedded in general practice and maternal and child health (MCH) nursing services in disadvantaged suburbs of Melbourne, Australia. Women who were pregnant or with infants, identified as abused or symptomatic of abuse, were referred by IPV-trained GPs and MCH nurses from 24 general practices and eight nurse teams from January 2006 to December 2007. Women in the intervention arm received up to 12 months support from trained and supported non-professional mentor mothers. Vietnamese health professionals also referred Vietnamese women to bilingual mentors in a sub-study. Baseline and follow-up surveys at 12 months measured IPV (CAS), depression (EPDS), general health (SF-36), social support (MOS-SF) and attachment to children (PSI-SF). Significant development and piloting occurred prior to trial commencement. Implementation interviews with MCH nurses, GPs and mentors assisted further refinement of the intervention. In-depth interviews with participants and mentors, and follow-up surveys of MCH nurses and GPs at trial conclusion will shed further light on MOSAIC's impact. DISCUSSION: Despite significant challenges, MOSAIC will make an important contribution to the need for evidence of effective partner violence interventions, the role of non-professional mentors in partner violence support services and the need for more evaluation of effective health professional training and support in caring for abused women and children among their populations. TRIAL REGISTRATION: ACTRN12607000010493.

COSMOS: COmparing Standard Maternity care with one-to-one midwifery support: a randomised controlled trial.

BACKGROUND: In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6-12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail. METHODS/DESIGN: A two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self administered survey) and at 2 and 6 months postpartum by postal survey. Medical/obstetric outcomes will be abstracted from the medical record. The sample size of 2008 was calculated to identify a decrease in caesarean birth from 19 to 14% and detect a range of other significant clinical differences. Comprehensive process and economic evaluations will be conducted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN012607000073404.

Birth then and now.

Halfway through the 20th century, views on pain in labour encompassed almost everything from women's self-blame to blaming nurses, midwives, doctors or partners for 'bad experiences'. Soon after that, giving birth came to be seen - in some settings and by some caregivers - as a 'natural' and thus benign event which women could 'master'. In their recent systematic review of women's expectations and experiences of pain relief in labour, Joanne Lally, Madeleine Murtagh, Sheila Macphail, and Richard Thomson show that there is wide variation in women's expectations and knowledge about the first birth. This systematic review provides us with a strong basis for reflection and action.

Recruitment to research studies in maternity hospitals: an example from the Early Births Study.

OBJECTIVES: to present issues associated with recruitment of women in maternity hospitals to a population-based case-control study of very preterm birth. DESIGN: a descriptive study of the recruitment process. SETTING: all maternity hospitals, including three providing neonatal intensive care services, in Victoria, Australia from April 2002 to April 2004. PARTICIPANTS: cases were women who had a singleton birth between 20 and 31+6 weeks of gestation. Controls were a random selection of women having a singleton birth of at least 37 completed weeks of gestation in the same time period as the cases. MEASUREMENTS AND FINDINGS: ethical approval was obtained from 73 of 77 maternity hospitals. Hospitals considered that privacy laws required that women should be approached initially by hospital staff for recruitment into the research study. Extensive effort was put into liaising with hospital personnel, determining hospital-specific protocols for approaching women and developing relationships with doctors, midwives and ward clerks. Recurrent reminders were provided to all hospitals. Of the 2785 women (cases and controls) ascertained as eligible, 13% of cases with surviving babies, 11% of controls and 74% of cases whose babies did not survive were not approached to participate in the study. Within these groups, there was variation by gestation and hospital. Once women were approached, 72% were interviewed. The interview response proportion was 50%. KEY CONCLUSIONS: recruitment to studies in the maternity setting in the postpartum period is a challenge. Barriers to recruitment that may have introduced selection bias in this study include: recruitment at many hospitals; short postnatal hospital stay; reliance on hospital staff to make the first approach to women; and low response from women whose babies did not survive. A dialogue between researchers and clinical midwives is proposed to explore ways of increasing researchers' understanding of the complex and demanding hospital environment, and to improve research awareness among clinical midwives.

Is the organisation and structure of hospital postnatal care a barrier to quality care? Findings from a state-wide review in Victoria, Australia.

OBJECTIVE: to describe the structure and organisation of hospital postnatal care in Victoria, Australia. DESIGN: postal survey sent to all public hospitals in Victoria (n=71) and key-informant interviews with midwives and medical practitioners (n=38). SETTING: Victoria, Australia. PARTICIPANTS: providers of postnatal care in Victorian public hospitals. FINDINGS: there is significant diversity across Victoria in the way postnatal units are structured and organised and in the way care is provided. There are differences in numerous practices, including maternal and neonatal observations and the length of time women spend in hospital after giving birth. Although the benefits of continuity of care are recognised by health care providers, continuity is difficult to provide in the postnatal period. Postnatal care is provided in busy, sometimes chaotic environments, with many barriers to providing effective care and few opportunities for women to rest and recover after childbirth. The findings in this study can, in part, be explained by the lack of evidence that has been available to guide early postnatal care. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: current structures such as standard postnatal documentation (clinical pathways) and fixed length of stay, may inhibit rather than support individualised care for women after childbirth. There is a need to move towards greater flexibility in providing of early postnatal care, including alternative models of service delivery; choice and flexibility in the length of stay after birth; a focus on the individual with far less emphasis on care being structured around organisational requirements; and building an evidence base to guide care.

Oestrogen treatment for tall stature in girls: estimating the effect on height and the error in height prediction.

OBJECTIVE: To determine the effect of oestrogen treatment on attenuating the growth of tall girls after adjusting for error in height prediction. DESIGN: Retrospective cohort study. PATIENTS: Tall girls assessed by Australian paediatric endocrinologists between 1959 and 1993. A total of 279 girls received oestrogen treatment (diethylstilboestrol or ethinyl oestradiol) and 367 girls were assessed but not treated. MEASUREMENTS: Estimated mature height (EMH) was calculated using radiographic assessment of bone age in adolescence. Final adult height was self-reported at follow-up. To control for error in the EMH predictions and their different distributions by treatment status, pairs of treated and untreated girls, matched on EMH within 1 cm, were selected for analysis. Covariate adjusted estimates of treatment effect (final height - EMH) were calculated. RESULTS In the sample of 108 matched pairs, the mean difference between the final height and EMH was -1.4 cm (SE 0.29) in the treated group and 1.1 cm (SE 0.23) in the untreated group, giving an unadjusted treatment effect of -2.5 cm (95% CI -3.2 to 1.8). A regression model based on 107 pairs of treated and untreated girls contained a significant interaction between bone age at treatment initiation and treatment, which estimated an approximately 1 cm per year decrease in treatment effect. The treatment effect was greatest in those commencing treatment at an early bone age and was significant if initiated before a bone age of 15 years. CONCLUSIONS: On average, oestrogen treatment resulted in an adult height that was less than predicted. Although treatment was more effective in the least mature girls, the mean height difference was relatively modest for most treated girls.

Hospital ethics approval for a population-based case-control study of very preterm birth.

AIM: To describe the process involved in obtaining ethics approval for a study aiming to recruit women from all maternity hospitals in Victoria, Australia. DESIGN: Observational data of the application process involving 85 hospitals throughout Victoria in 2001. RESULTS: Twenty-three of the 85 hospitals had a Human Research Ethics Committee (HREC) constituted in accordance with the National Health and Medical Council requirements; 27 agreed to accept decisions from other hospitals having HRECs and 27 relied on ethics advisory committees, hospital managers, clinical staff, quality assurance committees or lawyers for ethics decisions. Four of the latter did not approve the study. Eight hospitals no longer provided maternity services in the recruitment period. The process took 16 months, 26,000 sheets of paper, 258 copies of the application and the cost was about $30,000. Approval was eventually obtained for recruitment at 73 hospitals. DISCUSSION: Difficulties exist in obtaining timely ethics approval for multicentre studies due to a complex uncoordinated system. All hospitals should have explicit protocols for dealing with research ethics applications so that they can be processed in a straightforward and timely manner. To facilitate this, those without properly constituted HRECs should be affiliated with one hospital that has an HREC.