Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers.

BACKGROUND: The bacille Calmette-Guérin (BCG) vaccine has immunomodulatory "off-target" effects that have been hypothesized to protect against coronavirus disease 2019 (Covid-19). METHODS: In this international, double-blind, placebo-controlled trial, we randomly assigned health care workers to receive the BCG-Denmark vaccine or saline placebo and followed them for 12 months. Symptomatic Covid-19 and severe Covid-19, the primary outcomes, were assessed at 6 months; the primary analyses involved the modified intention-to-treat population, which was restricted to participants with a negative test for severe acute respiratory syndrome coronavirus 2 at baseline. RESULTS: A total of 3988 participants underwent randomization; recruitment ceased before the planned sample size was reached owing to the availability of Covid-19 vaccines. The modified intention-to-treat population included 84.9% of the participants who underwent randomization: 1703 in the BCG group and 1683 in the placebo group. The estimated risk of symptomatic Covid-19 by 6 months was 14.7% in the BCG group and 12.3% in the placebo group (risk difference, 2.4 percentage points; 95% confidence interval [CI], -0.7 to 5.5; P = 0.13). The risk of severe Covid-19 by 6 months was 7.6% in the BCG group and 6.5% in the placebo group (risk difference, 1.1 percentage points; 95% CI, -1.2 to 3.5; P = 0.34); the majority of participants who met the trial definition of severe Covid-19 were not hospitalized but were unable to work for at least 3 consecutive days. In supplementary and sensitivity analyses that used less conservative censoring rules, the risk differences were similar but the confidence intervals were narrower. There were five hospitalizations due to Covid-19 in each group (including one death in the placebo group). The hazard ratio for any Covid-19 episode in the BCG group as compared with the placebo group was 1.23 (95% CI, 0.96 to 1.59). No safety concerns were identified. CONCLUSIONS: Vaccination with BCG-Denmark did not result in a lower risk of Covid-19 among health care workers than placebo. (Funded by the Bill and Melinda Gates Foundation and others; BRACE ClinicalTrials.gov number, NCT04327206.).

Nurse home visiting to improve child and maternal outcomes: 5-year follow-up of an Australian randomised controlled trial.

OBJECTIVES: Nurse home visiting (NHV) is widely implemented to address inequities in child and maternal health. However, few studies have examined longer-term effectiveness or delivery within universal healthcare systems. We evaluated the benefits of an Australian NHV program ("right@home") in promoting children's language and learning, general and mental health, maternal mental health and wellbeing, parenting and family relationships, at child ages 4 and 5 years. SETTING AND PARTICIPANTS: Randomised controlled trial of NHV delivered via universal, child and family health services (the comparator). Pregnant women experiencing adversity (≥2 of 10 risk factors) were recruited from 10 antenatal clinics across 2 states (Victoria, Tasmania) in Australia. INTERVENTION: Mothers in the intervention arm were offered 25 nurse home visits (mean 23·2 home visits [SD 7·4, range 1-43] received) of 60-90 minutes, commencing antenatally and continuing until children's second birthdays. PRIMARY AND SECONDARY OUTCOMES MEASURED: At 4 and 5 years, outcomes were assessed via parent interview and direct assessment of children's language and learning (receptive and expressive language, phonological awareness, attention, and executive function). Outcomes were compared between intervention and usual care arms (intention to treat) using adjusted regression with robust estimation to account for nurse/site. Missing data were addressed using multiple imputation and inverse probability weighting. RESULTS: Of 722 women enrolled in the trial, 225 of 363 (62%) intervention and 201 of 359 (56%) usual care women provided data at 5 years. Estimated group differences showed an overall pattern favouring the intervention. Statistical evidence of benefits was found across child and maternal mental health and wellbeing, parenting and family relationships with effect sizes ranging 0·01-0·27. CONCLUSION: An Australian NHV program promoted longer-term family functioning and wellbeing for women experiencing adversity. NHV can offer an important component of a proportionate universal system that delivers support and intervention relative to need. TRIAL REGISTRATION: 2013-2016, registration ISRCTN89962120.

Identification of families in need of support: Correlates of adverse childhood experiences in the right@home sustained nurse home visiting program.

BACKGROUND: Little is known about the efficacy of pregnancy screening tools using non-sensitive sociodemographic questions to identify the possible presence of as yet undiagnosed disease in individuals and later adverse childhood events disclosure. OBJECTIVES: The study aims were to: 1) record the prevalence of risk disclosed by families during receipt of a sustained nurse home visiting program; and 2) explore patterns of relationships between the disclosed risks for their child having adverse experiences and the antenatal screening tool, which used non-sensitive demographic questions. DESIGN: Retrospective, observational study. PARTICIPANTS AND METHODS: Data about the participants in the intervention arm of the Australian right@home trial, which is scaffolded on the Maternal Early Childhood Sustained Home-visiting model, collected between 2013 and 2017 were used. Screening data from the 10-item antenatal survey of non-sensitive demographic risk factors and disclosed risks recorded by the nurse in audited case files during the subsequent 2 year intervention were examined (n = 348). Prevalence of disclosed risks for their child having adverse experiences were analysed in 2019 using multiple response frequencies. Phi correlations were conducted to test associations between screening factors and disclosed risks. RESULTS: Among the 348 intervention participants whose files were audited, 300 were noted by nurses to have disclosed risks during the intervention, with an average of four disclosures. The most prevalent maternal disclosures were depression or anxiety (57.8%). Mental health issues were the most prevalent partner and family disclosures. Screening tool questions on maternal smoking in pregnancy, not living with another adult, poverty and self-reporting anxious mood were significantly associated with a number of disclosed risks for their child having adverse experiences. CONCLUSIONS: These findings suggest that a non-sensitive sociodemographic screening tool may help to identify families at higher risk for adverse childhood experiences for whom support from a sustained nurse home visiting program may be beneficial.

Economic evaluation of an Australian nurse home visiting programme: a randomised trial at 3 years.

OBJECTIVES: To investigate the additional programme cost and cost-effectiveness of 'right@home' Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care. DESIGN: A cost-utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%. Analysis used an intention-to-treat approach with multiple imputation. SETTING: The right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years. PARTICIPANTS: 722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359). PRIMARY AND SECONDARY OUTCOME MEASURES: First, a cost-consequences analysis to compare the additional costs of NHV over usual care, accounting for any reduced costs of service use, and impacts on all maternal and child outcomes assessed at 3 years. Second, cost-utility analysis from a government-as-payer perspective compared additional costs to maternal QALYs to express cost-effectiveness in terms of additional cost per additional QALY gained. RESULTS: When compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI -0.01 to 0.02). The probability of right@home being cost-effective by child age 3 years is less than 20%, at a willingness-to-pay threshold of $A50 000 per QALY. CONCLUSIONS: Benefits of NHV to parenting at 2 years and maternal health and well-being at 3 years translate into marginal maternal QALY gains. Like previous cost-effectiveness results for NHV programmes, right@home is not cost-effective at 3 years. Given the relatively high up-front costs of NHV, long-term follow-up is needed to assess the accrual of health and economic benefits over time. TRIAL REGISTRATION NUMBER: ISRCTN89962120.

Patterns of maternal depression, anxiety, and stress symptoms from pregnancy to 5 years postpartum in an Australian cohort experiencing adversity.

The objective of this study is to describe the longitudinal patterns of depression, anxiety, and stress symptoms from pregnancy to 5 years postpartum, in a cohort of Australian mothers experiencing adversity. Longitudinal data were drawn from the control group of a trial of nurse home visiting. Pregnant women experiencing adversity (≥ 2 of 10 adversity risk factors) were recruited from antenatal clinics across 2 Australian states (30 April 2013-29 August 2014). Women completed the Depression Anxiety and Stress Scales short-form (DASS-21) at 11 time-points from pregnancy to 5 years postpartum. DASS-21 scores were summarized at each time-point for all women and by level of adversity risk. Three hundred fifty-nine women (100%) completed the DASS-21 in pregnancy and 343 (96%) provided subsequent data. Mental health symptoms were highest in pregnancy and at 4 and 5 years postpartum. While this pattern was comparable across levels of antenatal adversity risk, women with greatest adversity risk had consistently higher mental health symptoms. In a cohort of mothers experiencing adversity, depression, anxiety, and stress symptoms were highest in pregnancy and at 4 to 5 years postpartum. The striking patterns of persistent, high, mental health symptoms, beyond the first year postpartum, can inform a more equitable and responsive health system.

Nurse Home Visiting and Maternal Mental Health: 3-Year Follow-Up of a Randomized Trial.

BACKGROUND: Poor mental health is recognized as one of the greatest global burdens of disease. Maternal mental health is crucial for the optimal health of mothers and their children. We examined the effects of an Australian Nurse Home Visiting (NHV) program (right@home), offered to pregnant women experiencing adversity, on maternal mental health and well-being at child age 3 years. METHODS: A randomized controlled trial of NHV delivered via universal child and family health services (2013-2016). Pregnant women experiencing adversity (≥2 of 10 risk factors) were recruited from 10 antenatal clinics across 2 states. Intervention comprised 25 home visits until child age 2 years. The outcomes assessed 1-year postintervention completion were maternal self-report of mental health symptoms (Depression Anxiety Stress Scales) and positive aspects of mental health (personal well-being and self-efficacy). RESULTS: Of the 722 women enrolled in the trial, 255 of 363 (70%) intervention and 240 of 359 (67%) control group women provided data at 3 years. Compared with controls, the intervention group reported better mental health (reverse Depression Anxiety Stress Scales scores): effect sizes of 0.25 (depression; 95% confidence interval [CI]: 0.08 to 0.32), 0.20 (anxiety; 95% CI: 0.05 to 0.30), 0.17 (stress; 95% CI: 0.09 to 0.37), and 0.23 (total score; 95% CI: 0.12 to 0.38); 0.16 (95% CI: 0.04 to 0.29) for personal well-being; and an odds ratio of 1.60 (95% CI: 1.19 to 2.16) for self-efficacy. CONCLUSIONS: An NHV designed to support mothers experiencing adversity can lead to later maternal mental health benefits, even after the program ends.

Health service utilisation and unmet healthcare needs of Australian children from immigrant families: A population-based cohort study.

Compared with most other Organization for Economic Co-operation and Development (OECD) countries, information about the patterns of health service use for children from immigrant families in Australia is currently limited, and internationally, data on unmet healthcare needs are scarce. This study aims to examine the distribution of health service utilisation and unmet healthcare needs for immigrant children aged 10-11 years in Australia. We drew on data from the Longitudinal Study of Australian Children Birth (B; n = 5,107) and Kindergarten (K; n = 4,983) cohorts. The exposure was family immigration background collected at 0-1 (B-cohort) and 4-5 (K-cohort) years. Outcomes were parent-reported child health service use and unmet healthcare needs (defined as the difference between services needed and services received) at 10-11 years. Logistic regression analyses were used to examine associations between family immigration background and health service use/unmet healthcare needs, adjusting for potential confounders. Results showed that one-third of Australian children (B-cohort: 29.0%; K-cohort: 33.4%) came from immigrant families. There were similar patterns of health service use and unmet healthcare needs between children from English-speaking immigrant and Australian-born families. However, children from non-English-speaking immigrant families used fewer health services, including paediatric, dental, mental health and emergency ward services. There was a disparity between the services used when considering children's health needs, particularly for paediatric specialist services (B-cohort: OR = 2.43, 95% CI 1.11-5.31; K-cohort: OR = 2.72, 95% CI 1.32-5.58). Findings indicate that Australian children from non-English-speaking immigrant families experience more unmet healthcare needs and face more barriers in accessing health services. Further effort is needed to ensure that the healthcare system meets the needs of all families.

Nurse Home Visiting for Families Experiencing Adversity: A Randomized Trial.

OBJECTIVES: Nurse home visiting (NHV) may redress inequities in children's health and development evident by school entry. We tested the effectiveness of an Australian NHV program (right@home), offered to pregnant women experiencing adversity, hypothesizing improvements in (1) parent care, (2) responsivity, and (3) the home learning environment at child age 2 years. METHODS: A randomized controlled trial of NHV delivered via universal child and family health services was conducted. Pregnant women experiencing adversity (≥2 of 10 risk factors) with sufficient English proficiency were recruited from antenatal clinics at 10 hospitals across 2 states. The intervention comprised 25 nurse visits to child age 2 years. Researchers blinded to randomization assessed 13 primary outcomes, including Home Observation of the Environment (HOME) Inventory (6 subscales) and 25 secondary outcomes. REULTS: Of 1427 eligible women, 722 (50.6%) were randomly assigned; 306 of 363 (84%) women in the intervention and 290 of 359 (81%) women in the control group provided 2-year data. Compared with women in the control group, those in the intervention reported more regular child bedtimes (adjusted odds ratio 1.76; 95% confidence interval [CI] 1.25 to 2.48), increased safety (adjusted mean difference [AMD] 0.22; 95% CI 0.07 to 0.37), increased warm parenting (AMD 0.09; 95% CI 0.02 to 0.16), less hostile parenting (reverse scored; AMD 0.29; 95% CI 0.16 to 0.41), increased HOME parental involvement (AMD 0.26; 95% CI 0.14 to 0.38), and increased HOME variety in experience (AMD 0.20; 95% CI 0.07 to 0.34). CONCLUSIONS: The right@home program improved parenting and home environment determinants of children's health and development. With replicability possible at scale, it could be integrated into Australian child and family health services or trialed in countries with similar child health services.

Evidence for a comprehensive approach to Aboriginal tobacco control to maintain the decline in smoking: an overview of reviews among Indigenous peoples.

BACKGROUND: Tobacco smoking is a leading cause of disease and premature mortality among Aboriginal and Torres Strait Islander (Indigenous) Australians. While the daily smoking prevalence among Indigenous Australians has declined significantly from 49% in 2001, it remains about three times higher than that of non-Indigenous Australians (39 and 14%, respectively, for age ≥15 years in 2014-15). This overview of systematic reviews aimed to synthesise evidence about reducing tobacco consumption among Indigenous peoples using a comprehensive framework for Indigenous tobacco control in Australia comprised of the National Tobacco Strategy (NTS) and National Aboriginal and Torres Strait Islander Health Plan (NATSIHP) principles and priorities. METHODS: MEDLINE, EMBASE, systematic review and Indigenous health databases were searched (2000 to Jan 2016) for reviews examining the effects of tobacco control interventions among Indigenous peoples. Two reviewers independently screened reviews, extracted data, and assessed review quality using Assessing the Methodological Quality of Systematic Reviews. Data were synthesised narratively by framework domain. Reporting followed the PRISMA statement. RESULTS: Twenty-one reviews of varying quality were included. There was generally limited Indigenous-specific evidence of effective interventions for reducing smoking; however, many reviewers recommended multifaceted interventions which incorporate Indigenous leadership, partnership and engagement and cultural tailoring. Under the NTS priority areas, reviewers reported evidence for brief smoking cessation interventions and pharmacological support, mass media campaigns (on knowledge and attitudes) and reducing affordability and regulation of tobacco sales. Aspects of intervention implementation related to the NATSIHP domains were less well described and evidence was limited; however, reviewers suggested that cultural tailoring, holistic approaches and building workforce capacity were important strategies to address barriers. There was limited evidence regarding social media and mobile applications, for Indigenous youth, pregnant women and prisoners, and no evidence regarding interventions to protect communities from industry interference, the use of electronic cigarettes, interventions for people experiencing mental illness, juvenile justice, linguistic diversity or 'pubs, clubs and restaurants'. CONCLUSIONS: There is limited Indigenous-specific evidence for most tobacco interventions. A 'comprehensive approach' incorporating NTS and NATSIHP Principles and Priorities of partnership and engagement, evidence from other settings, programme logic and responsive evaluation plans may improve intervention acceptability, effectiveness and implementation and mitigate risks of adapting tobacco evidence for Indigenous Australians.

Psychosocial interventions for supporting women to stop smoking in pregnancy.

BACKGROUND: Tobacco smoking remains one of the few preventable factors associated with complications in pregnancy, and has serious long-term implications for women and babies. Smoking in pregnancy is decreasing in high-income countries, but is strongly associated with poverty and is increasing in low- to middle-income countries. OBJECTIVES: To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. SEARCH METHODS: In this sixth update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register (13 November 2015), checked reference lists of retrieved studies and contacted trial authors. SELECTION CRITERIA: Randomised controlled trials, cluster-randomised trials, and quasi-randomised controlled trials of psychosocial smoking cessation interventions during pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and trial quality, and extracted data. Direct comparisons were conducted in RevMan, with meta-regression conducted in STATA 14. MAIN RESULTS: The overall quality of evidence was moderate to high, with reductions in confidence due to imprecision and heterogeneity for some outcomes. One hundred and two trials with 120 intervention arms (studies) were included, with 88 trials (involving over 28,000 women) providing data on smoking abstinence in late pregnancy. Interventions were categorised as counselling, health education, feedback, incentives, social support, exercise and dissemination.In separate comparisons, there is high-quality evidence that counselling increased smoking cessation in late pregnancy compared with usual care (30 studies; average risk ratio (RR) 1.44, 95% confidence interval (CI) 1.19 to 1.73) and less intensive interventions (18 studies; average RR 1.25, 95% CI 1.07 to 1.47). There was uncertainty whether counselling increased the chance of smoking cessation when provided as one component of a broader maternal health intervention or comparing one type of counselling with another. In studies comparing counselling and usual care (largest comparison), it was unclear whether interventions prevented smoking relapse among women who had stopped smoking spontaneously in early pregnancy. However, a clear effect was seen in smoking abstinence at zero to five months postpartum (11 studies; average RR 1.59, 95% CI 1.26 to 2.01) and 12 to 17 months (two studies, average RR 2.20, 95% CI 1.23 to 3.96), with a borderline effect at six to 11 months (six studies; average RR 1.33, 95% CI 1.00 to 1.77). In other comparisons, the effect was unclear for most secondary outcomes, but sample sizes were small.Evidence suggests a borderline effect of health education compared with usual care (five studies; average RR 1.59, 95% CI 0.99 to 2.55), but the quality was downgraded to moderate as the effect was unclear when compared with less intensive interventions (four studies; average RR 1.20, 95% CI 0.85 to 1.70), alternative interventions (one study; RR 1.88, 95% CI 0.19 to 18.60), or when smoking cessation health education was provided as one component of a broader maternal health intervention.There was evidence feedback increased smoking cessation when compared with usual care and provided in conjunction with other strategies, such as counselling (average RR 4.39, 95% CI 1.89 to 10.21), but the confidence in the quality of evidence was downgraded to moderate as this was based on only two studies and the effect was uncertain when feedback was compared to less intensive interventions (three studies; average RR 1.29, 95% CI 0.75 to 2.20).High-quality evidence suggests incentive-based interventions are effective when compared with an alternative (non-contingent incentive) intervention (four studies; RR 2.36, 95% CI 1.36 to 4.09). However pooled effects were not calculable for comparisons with usual care or less intensive interventions (substantial heterogeneity, I2 = 93%).High-quality evidence suggests the effect is unclear in social support interventions provided by peers (six studies; average RR 1.42, 95% CI 0.98 to 2.07), in a single trial of support provided by partners, or when social support for smoking cessation was provided as part of a broader intervention to improve maternal health.The effect was unclear in single interventions of exercise compared to usual care (RR 1.20, 95% CI 0.72 to 2.01) and dissemination of counselling (RR 1.63, 95% CI 0.62 to 4.32).Importantly, high-quality evidence from pooled results demonstrated that women who received psychosocial interventions had a 17% reduction in infants born with low birthweight, a significantly higher mean birthweight (mean difference (MD) 55.60 g, 95% CI 29.82 to 81.38 g higher) and a 22% reduction in neonatal intensive care admissions. However the difference in preterm births and stillbirths was unclear. There did not appear to be adverse psychological effects from the interventions.The intensity of support women received in both the intervention and comparison groups has increased over time, with higher-intensity interventions more likely to have higher-intensity comparisons, potentially explaining why no clear differences were seen with increasing intervention intensity in meta-regression analyses. Among meta-regression analyses: studies classified as having 'unclear' implementation and unequal baseline characteristics were less effective than other studies. There was no clear difference between trials implemented by researchers (efficacy studies), and those implemented by routine pregnancy staff (effectiveness studies), however there was uncertainty in the effectiveness of counselling in four dissemination trials where the focus on the intervention was at an organisational level. The pooled effects were similar in interventions provided for women classified as having predominantly low socio-economic status, compared to other women. The effect was significant in interventions among women from ethnic minority groups; however not among indigenous women. There were similar effect sizes in trials with biochemically validated smoking abstinence and those with self-reported abstinence. It was unclear whether incorporating use of self-help manuals or telephone support increased the effectiveness of interventions. AUTHORS' CONCLUSIONS: Psychosocial interventions to support women to stop smoking in pregnancy can increase the proportion of women who stop smoking in late pregnancy and the proportion of infants born low birthweight. Counselling, feedback and incentives appear to be effective, however the characteristics and context of the interventions should be carefully considered. The effect of health education and social support is less clear. New trials have been published during the preparation of this review and will be included in the next update.

Physical health after childbirth and maternal depression in the first 12 months post partum: results of an Australian nulliparous pregnancy cohort study.

OBJECTIVE: to investigate the relationship between maternal physical health problems and depressive symptoms in the first year after childbirth. DESIGN: prospective pregnancy cohort study. SETTING: Melbourne, Victoria, Australia. POPULATION: 1507 nulliparous women. METHODS: women were recruited from six public hospitals between six and 24 weeks gestation. Written questionnaires were completed at recruitment and at three, six and 12 months post partum. OUTCOME MEASURES: Edinburgh Postnatal Depression Scale (EPDS); standardised measures of urinary and faecal incontinence, a checklist of symptoms for other physical health problems. RESULTS: overall, 16.1% of women reported depressive symptoms during the first 12 months post partum, with point prevalence at three, six and 12 months post partum of 6.9%, 8.8% and 7.8% respectively. The most commonly reported physical health problems in the first three months were tiredness (67%), back pain (47%), breast problems (37%), painful perineum (30%), and urinary incontinence (29%). Compared with women reporting 0-2 health problems in the first three months post partum, women reporting 5 or more health problems had a six-fold increase in likelihood of reporting concurrent depressive symptoms at three months post partum (Adjusted OR=6.69, 95% CI=3.0-15.0) and a three-fold increase in likelihood of reporting subsequent depressive symptoms at 6-12 months post partum (Adjusted OR=3.43, 95% CI 2.1-5.5). CONCLUSIONS: poor physical health in the early postnatal period is associated with poorer mental health throughout the first 12 months post partum. Early intervention to promote maternal mental health should incorporate assessment and intervention to address common postnatal physical health problems.

Psychosocial interventions for supporting women to stop smoking in pregnancy.

BACKGROUND: Tobacco smoking in pregnancy remains one of the few preventable factors associated with complications in pregnancy, stillbirth, low birthweight and preterm birth and has serious long-term implications for women and babies. Smoking in pregnancy is decreasing in high-income countries, but is strongly associated with poverty and increasing in low- to middle-income countries. OBJECTIVES: To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. SEARCH METHODS: In this fifth update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2013), checked reference lists of retrieved studies and contacted trial authors to locate additional unpublished data. SELECTION CRITERIA: Randomised controlled trials, cluster-randomised trials, randomised cross-over trials, and quasi-randomised controlled trials (with allocation by maternal birth date or hospital record number) of psychosocial smoking cessation interventions during pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and trial quality, and extracted data. Direct comparisons were conducted in RevMan, and subgroup analyses and sensitivity analysis were conducted in SPSS. MAIN RESULTS: Eighty-six trials were included in this updated review, with 77 trials (involving over 29,000 women) providing data on smoking abstinence in late pregnancy.In separate comparisons, counselling interventions demonstrated a significant effect compared with usual care (27 studies; average risk ratio (RR) 1.44, 95% confidence interval (CI) 1.19 to 1.75), and a borderline effect compared with less intensive interventions (16 studies; average RR 1.35, 95% CI 1.00 to 1.82). However, a significant effect was only seen in subsets where counselling was provided in conjunction with other strategies. It was unclear whether any type of counselling strategy is more effective than others (one study; RR 1.15, 95% CI 0.86 to 1.53). In studies comparing counselling and usual care (the largest comparison), it was unclear whether interventions prevented smoking relapse among women who had stopped smoking spontaneously in early pregnancy (eight studies; average RR 1.06, 95% CI 0.93 to 1.21). However, a clear effect was seen in smoking abstinence at zero to five months postpartum (10 studies; average RR 1.76, 95% CI 1.05 to 2.95), a borderline effect at six to 11 months (six studies; average RR 1.33, 95% CI 1.00 to 1.77), and a significant effect at 12 to 17 months (two studies, average RR 2.20, 95% CI 1.23 to 3.96), but not in the longer term. In other comparisons, the effect was not significantly different from the null effect for most secondary outcomes, but sample sizes were small.Incentive-based interventions had the largest effect size compared with a less intensive intervention (one study; RR 3.64, 95% CI 1.84 to 7.23) and an alternative intervention (one study; RR 4.05, 95% CI 1.48 to 11.11).Feedback interventions demonstrated a significant effect only when compared with usual care and provided in conjunction with other strategies, such as counselling (two studies; average RR 4.39, 95% CI 1.89 to 10.21), but the effect was unclear when compared with a less intensive intervention (two studies; average RR 1.19, 95% CI 0.45 to 3.12).The effect of health education was unclear when compared with usual care (three studies; average RR 1.51, 95% CI 0.64 to 3.59) or less intensive interventions (two studies; average RR 1.50, 95% CI 0.97 to 2.31).Social support interventions appeared effective when provided by peers (five studies; average RR 1.49, 95% CI 1.01 to 2.19), but the effect was unclear in a single trial of support provided by partners.The effects were mixed where the smoking interventions were provided as part of broader interventions to improve maternal health, rather than targeted smoking cessation interventions.Subgroup analyses on primary outcome for all studies showed the intensity of interventions and comparisons has increased over time, with higher intensity interventions more likely to have higher intensity comparisons. While there was no significant difference, trials where the comparison group received usual care had the largest pooled effect size (37 studies; average RR 1.34, 95% CI 1.25 to 1.44), with lower effect sizes when the comparison group received less intensive interventions (30 studies; average RR 1.20, 95% CI 1.08 to 1.31), or alternative interventions (two studies; average RR 1.26, 95% CI 0.98 to 1.53). More recent studies included in this update had a lower effect size (20 studies; average RR 1.26, 95% CI 1.00 to 1.59), I(2)= 3%, compared to those in the previous version of the review (50 studies; average RR 1.50, 95% CI 1.30 to 1.73). There were similar effect sizes in trials with biochemically validated smoking abstinence (49 studies; average RR 1.43, 95% CI 1.22 to 1.67) and those with self-reported abstinence (20 studies; average RR 1.48, 95% CI 1.17 to 1.87). There was no significant difference between trials implemented by researchers (efficacy studies), and those implemented by routine pregnancy staff (effectiveness studies), however the effect was unclear in three dissemination trials of counselling interventions where the focus on the intervention was at an organisational level (average RR 0.96, 95% CI 0.37 to 2.50). The pooled effects were similar in interventions provided for women with predominantly low socio-economic status (44 studies; average RR 1.41, 95% CI 1.19 to 1.66), compared to other women (26 studies; average RR 1.47, 95% CI 1.21 to 1.79); though the effect was unclear in interventions among women from ethnic minority groups (five studies; average RR 1.08, 95% CI 0.83 to 1.40) and aboriginal women (two studies; average RR 0.40, 95% CI 0.06 to 2.67). Importantly, pooled results demonstrated that women who received psychosocial interventions had an 18% reduction in preterm births (14 studies; average RR 0.82, 95% CI 0.70 to 0.96), and infants born with low birthweight (14 studies; average RR 0.82, 95% CI 0.71 to 0.94). There did not appear to be any adverse effects from the psychosocial interventions, and three studies measured an improvement in women's psychological wellbeing. AUTHORS' CONCLUSIONS: Psychosocial interventions to support women to stop smoking in pregnancy can increase the proportion of women who stop smoking in late pregnancy, and reduce low birthweight and preterm births.

Have guidelines about smoking cessation support in pregnancy changed practice in Victoria, Australia?

BACKGROUND: Antenatal smoking cessation guidelines have been available in Victoria, Australia, for the past decade. The objective of this study was to assess to what extent introduction of smoking cessation guidelines in pregnancy changed practice in Victorian public hospitals. METHODS: Two population-based postal surveys of women giving birth in the state of Victoria, conducted in 2000 and 2008 before and after implementation of smoking cessation guidelines. Self-administered questionnaires were distributed by hospitals and home birth practitioners to women 5-6 months postpartum. RESULTS: Surveys were completed and returned by 67 percent of eligible women (1,616/2,412) in 2000 and 51% (2,900/5,681) in 2008. Compared with the 2000 survey, women in the 2008 survey attending public sector care were more likely: to receive advice on how to stop smoking (Adjusted Odds Ratio: 2.2, 95% CI 1.5-3.2); to be given written information (Adj OR: 2.7, 95% CI 1.8-4.0); to be referred to stop smoking programs (Adj OR: 6.1, 95% CI 3.1-11.7); and to have discussed smoking cessation at more than one visit (Adj OR: 1.5, 95% CI 1.0-2.2). While the majority of women in both surveys were asked about smoking in early pregnancy, about half of those smoking did not receive advice on how to stop or cut down; were not given written information; were not told about/referred to stop smoking programs and were not asked again about smoking at subsequent visits. The significant shift in women's reports of receiving smoking cessation advice and support between the two surveys occurred predominantly at public hospitals where women received all or some antenatal care. CONCLUSIONS: Smoking cessation guidelines in Victorian public hospitals have increased the extent to which pregnant women receive advice and support to stop or reduce smoking. However, half of smokers did not receive the full complement of advice and support according to state guidelines, with marked variability according to where and from whom women received antenatal care. Further efforts are needed to implement smoking cessation advice and support in clinical practice.

Maternal depression and physical health problems in early pregnancy: findings of an Australian nulliparous pregnancy cohort study.

OBJECTIVE: to investigate the relationship between physical health problems and depressive symptoms in early pregnancy. DESIGN: baseline questionnaire, prospective pregnancy cohort study. SETTING: six metropolitan public maternity hospitals in Victoria, Australia. PARTICIPANTS: 1507 nulliparous women recruited in early pregnancy. FINDINGS: nine per cent of women (131/1500) scored ≥ 13 on the EPDS indicating probable clinical depression in early pregnancy (mean gestation=15 weeks). The five most commonly reported physical health problems were as follows: exhaustion (86.9%), morning sickness (64.3%), back pain (45.6%), constipation (43.5%) and severe headaches or migraines (29.5%). Women scoring ≥ 13 on the EPDS reported a mean of six physical health problems compared with a mean of 3.5 among women scoring <13 on the EPDS. Women reporting five or more physical health problems had a three-fold increase in likelihood of reporting depressive symptoms (Adj OR=3.13, 95% CI 2.14-4.58) after adjusting for socio-demographic factors, including maternal age. CONCLUSIONS: the findings from this large multi-centre study show that women experiencing a greater number of physical health problems are at increased risk of reporting depressive symptoms in early pregnancy. IMPLICATIONS FOR PRACTICE: early detection and support for women experiencing physical and psychological health problems in pregnancy is an important aspect of antenatal care. The extent of co-morbid physical and psychological health problems underlines the need for comprehensive primary health care as an integral component of antenatal care.

Physical health and recovery in the first 18 months postpartum: does cesarean section reduce long-term morbidity?

BACKGROUND: Research examining long-term health outcomes for women after childbirth has been limited. The objective of this study was to investigate the natural history of common morbidities in the 18 months after the birth of a first child, and to explore the hypothesis that women who have a cesarean section for a first birth experience less overall morbidity in the postnatal period. METHODS: A prospective nulliparous pregnancy cohort study was conducted of 1,507 women recruited in early pregnancy from six public hospitals in Melbourne, Australia (mean gestation 15 weeks). Follow-up questionnaires at 3, 6, 12, and 18 months postpartum included standardized measures of urinary and fecal incontinence, and a symptom checklist asking about common physical health problems. RESULTS: At 6, 12, and 18 months postpartum, no statistically significant differences were found in the proportion of women reporting three or more health problems by method of birth. Compared with women who had a spontaneous vaginal birth, women who had a cesarean section were more likely to report extreme tiredness at 6 months postpartum (adjusted OR: 1.39; 95% CI: 1.07-1.82) and at 12 months postpartum (adjusted OR: 1.40; 95% CI: 1.05-1.85), and were more likely to report back pain at 6 months postpartum (adjusted OR: 1.37; 95% CI: 1.06-1.77) and at 12 months postpartum (adjusted OR: 1.41; 95% CI: 1.06-1.87). Women who had a cesarean section were less likely to report urinary incontinence at 3, 6, and 12 months postpartum, respectively (adjusted OR: 0.26; 95% CI: 0.19-0.36; adjusted OR: 0.36; 95% CI: 0.25-0.52; adjusted OR: 0.48; 95% CI: 0.33-0.68). For all other physical health problems the pattern of morbidity did not differ between cesarean section and spontaneous vaginal birth. CONCLUSIONS: Physical health problems commonly persist or recur throughout the first 18 months postpartum, with potential long-term consequences for women's health. Cesarean section does not result in women experiencing less overall morbidity in the postpartum period compared with women who have a spontaneous vaginal birth.

Women's health in early pregnancy: findings from an Australian nulliparous cohort study.

BACKGROUND: Much is known about severe maternal morbidity during pregnancy, but there has been little attention paid to the impact of pregnancy itself on women's general health and well-being. AIM: To investigate women's general health and well-being in early pregnancy and examine the relationship between maternal age and women's physical and mental health. METHOD: Cross-sectional analysis of baseline data from a multicentre, prospective nulliparous pregnancy cohort study. The baseline questionnaire included the SF-36 health status measure and individual items assessing a range of common maternal health issues. RESULTS: A total of 1507 eligible women returned baseline questionnaires in early pregnancy (mean gestation 15 weeks, range 6-24 weeks) ranging from 18 to 49 years of age (mean age 30.1 years). Study participants reported significantly poorer health compared with age and gender-standardised population means on all SF-36 scales except general health. Two-thirds of women (68%) reported three or more health issues, the most common being exhaustion (87%), nausea (64%), back pain (46%), constipation (44%) and severe headaches/migraines (30%). Younger women (18-24 years) had significantly lower SF-36 scores (poorer self perceived health) compared with women ≥ 35 (P ≤ 0.03). After adjusting for socio-demographic factors, maternal age remained significantly positively associated with women's mental and physical component scores. Younger women reported significantly more health issues than women ≥ 35 (4.39 and 3.27, mean difference = 1.12, 95% CI 0.75-1.79, P < 0.001). CONCLUSIONS: Common pregnancy symptoms have a marked impact on women's physical and mental health in early pregnancy, with the greatest impact apparent for younger women.

Seeking help for anxiety and depression after childbirth: results of the Maternal Health Study.

Access to treatment for postnatal anxiety and depression is dependant on women seeking help for psychological symptoms. The aim of this paper was to investigate what women themselves say about seeking help for emotional difficulties after childbirth. The Maternal Health Study is a prospective pregnancy cohort study investigating the physical and psychological health of 1,507 nulliparous women during pregnancy and after birth. One thousand, three hundred eighty-five women completed a computer-assisted telephone interview at 9 months postpartum; 8.5% of women reported intense anxiety or panic attacks occasionally or often, and 9.5% reported depressed mood, between 6 and 9 months postpartum. Of those experiencing anxiety symptoms alone 44.4% had spoken to a health professional, compared with 65.5% of women experiencing depressive symptoms alone (RR = 0.68, 95% CI-0.5 to 0.9). Measures of anxiety and depressive symptoms at 9 months postpartum were not validated against diagnostic criteria. Anxiety is a common experience in the perinatal period. More research is needed into this area to determine what levels of anxiety are 'normal' and acceptable to women during this period. Public health campaigns may have been more effective in encouraging women to seek help for depression than anxiety.