Preventing postnatal depression in new mothers using telephone peer support: protocol for the DAISY (Depression and AnxIety peer Support studY) multi-centre randomised controlled trial.

INTRODUCTION: Postnatal depression affects up to one in six new mothers in Australia each year, with significant impacts on the woman and her family. Prevention strategies can be complicated by a woman's reluctance to seek professional help. Peer support is a promising but inadequately tested early intervention. Very few trials have reported on the efficacy of peer support in the perinatal period and no study has been undertaken in Australia. We will explore if proactive telephone-based peer (mother-to-mother) support, provided to women identified as being at high risk of postnatal depression, impacts on clinically significant depressive symptomatology at 6 months postpartum. METHODS AND ANALYSIS: This is a protocol for a single-blinded, multi-centre, randomised controlled trial conducted in Melbourne, Australia. Eligible women will be recruited from either the postnatal units of two maternity hospitals, or around 4 weeks postpartum at maternal and child health centres within two metropolitan council areas. A total of 1060 (530/group) women will be recruited and randomly allocated (1:1 ratio) to either-usual care, to receive the standard community postpartum services available to them, or the intervention group, to receive proactive telephone-based support from a peer volunteer for 6 months, in addition to standard community services. PRIMARY OUTCOME: clinically significant depressive symptomatology at 6 months postpartum as measured using the Edinburgh Postnatal Depression Scale. SECONDARY OUTCOMES: symptoms of anxiety and/or stress, health-related quality of life, loneliness, perception of partner support, self-rated parenting, child health and development, infant feeding and health service use. The cost-effectiveness of the intervention relative to standard care will also be assessed. ETHICS AND DISSEMINATION: Ethics approval has been obtained from La Trobe University, St. Vincent's Hospital, the Royal Women's Hospital, Northern Health, Victorian Department of Health and Human Services and Victorian Department of Education and Training. Written informed consent will be obtained from all participants before randomisation. Trial results will be disseminated through peer-reviewed publications, conference presentations and a higher degree thesis. TRIAL REGISTRATION NUMBER: ACTRN12619000684123; Australian New Zealand Clinical Trials Registry.

What is 'physiological birth'? A scoping review of the perspectives of women and care providers.

PROBLEM: Physiological birth was defined by the World Health Organization in 1997, however, clinical practices in childbirth have changed considerably since this time. BACKGROUND: Ambiguous terms in healthcare such as 'physiological birth' may cause confusion amongst care providers and consumers. AIM: To identify what is known about physiological birth, and how perceptions of physiological birth manifest in current literature. METHODS: This review followed the Joanna Briggs Institute methodology for scoping reviews and the PRISMA-ScR checklist. Four databases were searched using keywords relating to physiological birth. Relevant studies were identified using agreed criteria, and data were extracted and synthesised. RESULTS: A total of 24 studies met the inclusion criteria for this review. Three connected factors were identified: (1) Physiological birth in a risk-averse system, (2) Dominant voices in birth, and (3) Lack of exposure to physiological birth. No unified universal definition of physiological birth was identified in the literature. DISCUSSION: 'Physiological birth' as a term lacks consistency. A risk-averse healthcare system could be a barrier to physiological birth. Dominant voices in the birthing space can dictate the way birth occurs. Lack of exposure to physiological birth may diminish the acquisition and maintenance of important skills and knowledge among care providers. Recognising the factors important to women could lead to a positive birth experience. CONCLUSION: Excluding a woman's subjective experience from health professionals' understanding of physiological birth increases the likelihood of risk management being the paramount objective in clinical decision-making. We propose it is timely to align clinical understanding of physiological birth with midwifery's woman-centred professional philosophy.

Is proactive telephone-based breastfeeding peer support a cost-effective intervention? A within-trial cost-effectiveness analysis of the 'Ringing Up about Breastfeeding earlY' (RUBY) randomised controlled trial.

OBJECTIVE: The 'Ringing Up about Breastfeeding earlY' (RUBY) randomised controlled trial showed increased breastfeeding at 6 months in participants who received the proactive telephone-based peer support breastfeeding intervention compared with participants allocated to receive standard care and supports. The present study aimed to evaluate if the intervention was cost-effective. DESIGN: A within-trial cost-effectiveness analysis. SETTING: Three metropolitan maternity services in Melbourne, Victoria, Australia. PARTICIPANTS: First time mothers intending to breastfeed their infant (1152) and peer volunteers (246). INTERVENTION: The intervention comprised proactive telephone-based support from a peer volunteer from early postpartum up to 6 months. Participants were allocated to usual care (n=578) or the intervention (n=574). MAIN OUTCOME MEASURES: Costs during a 6-month follow-up period including individual healthcare, breastfeeding support and intervention costs in all participants, and an incremental cost-effectiveness ratio. RESULTS: Costs per mother supported were valued at $263.75 (or $90.33 excluding costs of donated volunteer time). There was no difference between the two arms in costs for infant and mothers in healthcare and breastfeeding support costs. These figures result in an incremental cost-effectiveness ratio of $4146 ($1393 if volunteer time excluded) per additional mother breast feeding at 6 months. CONCLUSION: Considering the significant improvement in breastfeeding outcomes, this intervention is potentially cost-effective. These findings, along with the high value placed on the intervention by women and peer volunteers provides robust evidence to upscale the implementation of this intervention. TRIAL REGISTRATION NUMBER: ACTRN12612001024831.

Implementing a successful proactive telephone breastfeeding peer support intervention: volunteer recruitment, training, and intervention delivery in the RUBY randomised controlled trial.

BACKGROUND: The RUBY randomised controlled trial demonstrated the benefit of proactive telephone peer support in promoting breastfeeding continuation in a setting with high breastfeeding initiation, where typically this is difficult to achieve. This paper describes the implementation and delivery of the peer support intervention with a focus on recruitment, training, and support of peer volunteers, and includes a description of the key components of the calls. METHODS: Data collection occurred between December 2012 and June 2016 in Melbourne, Australia. Volunteers completed enrolment forms at the training session and recorded data related to each call in a Call Log maintained for each mother supported. Data were summarised using descriptive statistics and responses to open-ended questions analysed using content analysis. RESULTS: A total of 693 women expressed interest in the peer support role, with 246 completing training, that is, 95% of whom supported at least one mother. Each supported a mean of two mothers (range 1 to 11). Training session topics included respecting individual values, using positive language, confidence building, active listening, empathetic support, and normal baby behaviour. There were 518 periods of support where at least one call was made between a volunteer and a mother to whom she was allocated. Of the 518 periods of support, 359 Call Logs (69%) were returned. The 359 call logs recorded a total of 2398 calls between peers and mothers. Call length median duration was 12 min (range 1 to 111 min). Volunteers perceived the most valued aspects of the calls were the provsion of 'general emotional support' (51%) and 'general information/discussion about breastfeeding' (44%). During the first call, mothers raised questions about 'nipple pain/ damage' (24%) and 'general breastfeeding information' (23%). At ≥12 weeks postpartum, issues raised related to 'normal infant behaviour' (22%), 'feed frequency' (16%), and 'general breastfeeding information' (15%). Volunteers referred women to other resources during 28% of calls, most commonly to the Australian Breastfeeding Association. CONCLUSIONS: Our findings demonstrate that the RUBY trial was feasible and sustainable in terms of recruiting volunteers who were willing to participate in training and who proceeded to provide peer support. Call content was responsive to the evolving breastfeeding information needs of mothers and the provision of emotional support was perceived by volunteers to be important. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN 12612001024831 .

Breastfeeding peer support by telephone in the RUBY randomised controlled trial: A qualitative exploration of volunteers' experiences.

BACKGROUND: There is growing evidence that peer support programs may be effective in supporting breastfeeding mothers. A randomised controlled trial (RCT) (the RUBY study) that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age. METHODS: This qualitative sub-study of the RUBY RCT explores the experiences and views of peer volunteers who delivered the intervention. Focus groups were conducted with 17 peers from the RUBY RCT between November 2015 and March 2016. All had provided peer support to at least one mother. RESULTS: We found that volunteers identified strongly with the mothers' need for support when establishing breastfeeding. Key components of the support were strengthening the mothers' self-belief through affirmation and sharing experiential knowledge. Volunteers found the role rewarding and personally therapeutic although some women reported challenges initiating and maintaining contact with some mothers. Data were analysed using a hybrid approach to thematic analysis combining inductive and deductive techniques. CONCLUSIONS: Breastfeeding peer support programs are reliant on recruitment of motivated volunteers who can provide empathetic mother-to-mother support. This study provides important information regarding volunteers' experiences that may support the upscaling of breastfeeding peer support for new mothers. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN 12612001024831.

Proactive Peer (Mother-to-Mother) Breastfeeding Support by Telephone (Ringing up About Breastfeeding Early [RUBY]): A Multicentre, Unblinded, Randomised Controlled Trial.

BACKGROUND: Breastfeeding rates are suboptimal internationally, and many infants are not receiving any breast milk at all by six months of age. Few interventions increase breastfeeding duration, particularly where there is relatively high initiation. The effect of proactive peer (mother-to-mother) support has been found to increase breastfeeding in some contexts but not others, but if it is shown to be effective would be a potentially sustainable model in many settings. We aimed to determine whether proactive telephone-based peer support during the postnatal period increases the proportion of infants being breastfed at six months of age. METHODS: RUBY (Ringing Up about Breastfeeding earlY) was a multicentre, two-arm un-blinded randomised controlled trial conducted in three hospitals in Victoria, Australia. First-time mothers intending to breastfeed were recruited after birth and prior to hospital discharge, and randomly assigned (1:1) to usual care or usual care plus proactive telephone-based breastfeeding support from a trained peer volunteer for up to six months postpartum. A computerised random number program generated block sizes of four or six distributed randomly, with stratification by site. Research midwives were masked to block size, but masking of allocation was not possible. The primary outcome was the proportion of infants receiving any breast milk at six months of age. Analyses were by intention to treat; data were collected and analysed masked to group. The trial is registered with ACTRN, number 12612001024831. FINDINGS: Women were recruited between Feb 14, 2013 and Dec 15, 2015 and randomly assigned to peer support (n = 574) or usual care (n = 578). Five were not in the primary analysis [5 post-randomisation exclusions]. Infants of women allocated to telephone-based peer support were more likely than those allocated to usual care to be receiving breast milk at six months of age (intervention 75%, usual care 69%; Adj. RR 1·10; 95% CI 1·02, 1·18). There were no adverse events. INTERPRETATION: Providing first time mothers with telephone-based support from a peer with at least six months personal breastfeeding experience is an effective intervention for increasing breastfeeding maintenance in settings with high breastfeeding initiation. FUNDING: The Felton Bequest, Australia, philanthropic donation and La Trobe University grant.

Exploring the effect of the 'Growing Together' parenting education kit on early parenting - study protocol for a cluster randomised controlled trial.

BACKGROUND: Significant gaps exist in education for prospective and new parents, especially for some of the most vulnerable families. Prospective parents would like more information during pregnancy to prepare them for parenting, and need access to trusted and quality information. The Royal Women's Hospital (the Women's) in Melbourne, Australia, a large tertiary referral maternity hospital, developed a parenting education kit known as 'Growing Together'. The kit, designed to guide prospective and new parents from conception until 1 year after birth, includes three components: an A4 sized book, a specifically designed 'App' and a children's story book. We aim to evaluate the impact of the kit on a range of outcomes. METHODS: A two-arm cluster randomised controlled trial will be used. Antenatal clinic days will be randomised to either the intervention or standard care arms. Women in the intervention arm receive the kit at their antenatal booking visit. Women in the standard care arm receive the standard information resources at the Women's. Analyses will be by intention to treat. INCLUSION CRITERIA: primiparous women with adequate English-speaking ability and ≤ 30 weeks' gestation at first pregnancy booking appointment. The primary outcome of the study is the 'experience of motherhood questionnaire' (EMQ), a 20 item validated self-report measure, ranging from 0 to 80, with lower scores indicating better maternal health and wellbeing. To detect a 10% difference in new mothers scoring ≤40 between women who have received the kit (60%) and those who have not (50%), would require 408 per group (total of 816 women) with 95% confidence and 80% power. Allowing for loss to follow up, we aim to recruit 1000 mothers. Secondary outcomes include parents' views and experiences of their care and of the kit during pregnancy and after the birth, parental attachment, knowledge, confidence, wellbeing and health-seeking behaviour; and emotional, developmental and physical health of the infant. Survey data will be collected from mothers at 2, 6 and 12 months postpartum and partners at 6 months. DISCUSSION: This study will provide much needed high-level evidence on the impact of a comprehensive education resource for new parents. TRIAL REGISTRATION: ANZCTRN12615000270516 - Retrospectively registered (23/03/2015); trial started on 16 March 2015.

Ringing Up about Breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) - trial protocol.

BACKGROUND: The risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada. DESIGN/METHODS: A two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to 'usual' care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. HYPOTHESIS: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%).Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes. DISCUSSION: The costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites which have a high proportion of women from disadvantaged backgrounds. This will be the first Australian randomised controlled trial to test the effectiveness and cost effectiveness of proactive peer telephone support for breastfeeding. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612001024831.

Sources of information used by women during pregnancy to meet their information needs.

AIM OF THE STUDY: to explore the information sources used by women during pregnancy to meet their information needs regarding pregnancy, birth and the postpartum period. DESIGN: a cross-sectional postal survey of all eligible women who birthed at the Royal Women's Hospital, Melbourne, Australia between November 2010 and January 2011. Surveys were sent at four months post partum. FINDINGS: forty-seven per cent (350/752) of eligible women returned the surveys, of whom 62% were primiparous. 'Discussion with a midwife' was the source of information used by the greatest number of women during pregnancy (246/350, 70%). Less than half of the women used the internet to access information (154/350, 44%), and group information sessions were the least preferred information format (8/330, 2.4%). Women from non-English speaking backgrounds (NESB) were less likely to use written and online resources. One-third of the women had unmet learning needs, particularly in relation to breast feeding and postnatal recovery. Overall, women rated books as the most useful source of information (57/332, 17.2%). The model of pregnancy care influenced the source women rated as most useful. Women who received most of their pregnancy care from a midwife described discussion with a midwife as their most useful source of information (42/150, 28%). In contrast, of the group who received most of their care from a doctor in antenatal clinic, the largest proportion reported that the internet was their most useful source of information (10/57, 28%). CONCLUSION AND RECOMMENDATIONS: discussion with midwives is an important source of information for women. The internet did not play a significant role in information seeking for more than half of the women in the study. Existing sources of information may not meet the needs of women from NESB, either because women do not access the multilingual resources currently available or because resources may only be provided in English or a few other common languages.