A study of the provision of the emergency contraceptive pill (ECP) over-the-counter (OTC) in Australia

Angela Taft, Judith Lumley and Melissa Hobbs in collaboration with Kay Stewart and Colin Chapman, Victorian College of Pharmacy, Monash University; Julia Shelley, School of Health and Social development, Deakin University; and Anthony Smith, Australian Research Centre in Sex, Health and Society, La Trobe University A collaboration of researchers, together with Sexual Health and Family Planning Australia, is evaluating the implementation of the emergency contraceptive pill (ECP) over-the-counter (OTC) in Australia. The availability of ECP through Australian pharmacies could potentially make significant differences to rates of ECP use and reduce unwanted and unplanned pregnancies and abortion rates in Australia.

The study aims to:
• examine the effectiveness of the distribution of levonorgestrel as an ECP to Australian pharmacies;
• examine the training, attitudes and experience of dispensing ECP in a stratified random sample of Australian pharmacists;
• measure and explore the knowledge and cost of ECP, sociodemographic patterns of use and need for, as well as the barriers and facilitators of access to ECP in a random sample of sexually active Australian women aged between 16 to 35, prior to and after the implementation of OTC ECP in Australia;
• monitor, within the limits of available data, whether there has been any change in abortion rates among Australian women, especially
among teenagers, over the same period; and
• disseminate the findings of the study and develop recommendations to governments and other key stakeholders for enhanced
effectiveness of the OTC policy.

An analysis of ECP supplies to community pharmacies in 2006 demonstrated that all three forms of ECP were distributed to pharmacies in all postcodes where community pharmacies are located Australia-wide and would be potentially available in most pharmacies if requested. Six focus groups (n=29) with women recruited in four states found them to be typical of ECP users in a previous population study of Sex in Australia (Smith AMA et al, 2003) and their views confirmed those in the literature. Preparation and piloting of the computer-assisted telephone interview (CATI) survey with women has been completed. The full survey of 600 randomly selected Australian women aged 16-35 commences in February 2008. Planning for the pharmacy survey has also commenced.

FUNDING: Australian Research Council Linkage grant
STATUS: Ongoing, one letter on ECP published

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The emergency contraceptive pill rescheduled: knowledge, attitudes and practice among women – a sub-study of the study of the provision of the emergency contraceptive pill (ECP) over-the-counter (OTC) in Australia

Melissa Hobbs, Angela Taft, Judith Lumley, and Lisa Amir in collaboration with Kay Stewart, Victorian College of Pharmacy, Monash University

The aim of this study is to assess whether the rescheduling of the emergency contraceptive pill (ECP), levonorgestrel, in Australia has
improved its accessibility and use by women at risk of unwanted pregnancy.

The study is using both qualitative and quantitative methods, involving focus groups with women users of ECP to explore knowledge of, access to, attitudes towards and experiences of using ECP. The information obtained from these focus groups has informed the development of Computer Assisted Telephone Interviews (CATI) with a random sample of 600 Australian women.Six focus groups with women have been completed and analysed. An interview schedule for the CATI has been completed and piloted and the Hunter Valley Research Foundation will commence conducting the survey in February 2008.

FUNDING: Australian Postgraduate Award (Industry) (2006-2008)
STATUS: Focus groups completed and analysed, CATI piloted, letter published

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Australian women’s use of the emergency contraceptive pill: a descriptive study

Angela Taft, Melissa Hobbs, Lisa Amir and Lyn Watson, in collaboration with Women’s Health Australia, University of Newcastle
The study aims to analyse secondary data from the 2006 (4th) survey of the Young cohort from the Australian Longitudinal Study of
Women’s Health in order to:
• describe the proportions and characteristics of women who have used the emergency contraceptive pill since 2004; and
• their ease of access by area of residence and any other relevant factor e.g. socio-economic status in order to assess the current
patterns of use by women of this form of contraception.

FUNDING: None
STATUS: Ethics application submitted

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Termination of pregnancy in Australia: a descriptive analysis of trends over time and associations in the young women’s cohort of Women’s Health Australia

Angela Taft and Lyn Watson

Using the data from the 1996 and 2000 surveys of the young women’s cohorts from the Australian Longitudinal Women’s Health
Study (Women’s Health Australia) this analysis aimed to:• provide descriptive summary statistics of the population of young women who had one or more terminations, including sociodemographic characteristics, area of residence/location, and use of contraception, comparing them within age strata with (i) women who have not had a termination and (ii) those who have not had any pregnancy;
• examine the changes in reported terminations from the 1996 to the 2000 survey, and describe their relationship to other pregnancy outcomes in the same time period, for the whole young women’s cohort;
• compare the reported rate of terminations in these surveys with age specific rates from 1996 to 2000 collected through the mandatory reporting systems in South Australia and the Northern Territory, both of which produce annual reports; and
• undertake subsequent analysis examined factors associated with women reporting terminations, violence status and depression.

FUNDING: VicHealth Grant 2002; La Trobe University Faculty of Health Sciences Research Grant 2002
STATUS: One paper published and another under review

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Why are women using complementary and alternative medicine (CAM) to enhance fertility?

Infertility treatment is an increasing phenomenon in Australia and current trends in women’s age at first birth suggest more Australian couples will seek assisted reproductive technologies (ART) to achieve parenthood. Complementary and alternative medicine (CAM) has become a popular health care option for a variety of chronic health conditions and women are the primary users. While the national and international evidence demonstrates widespread use of CAM to alleviate reproductive and obstetric problems, there are many unknowns regarding CAM use to enhance or support fertility. Using focus groups this study aims to explore and describe the views and experiences of women who consult CAM therapists to enhance their fertility, as well as the experiences of CAM therapists who specialise in fertility enhancement. The information gathered will be used for developing the questionnaires and interview schedules for a proposed larger study.

FUNDING: None
STATUS: Three focus groups completed, transcription commenced and an abstract accepted for conference in April 2008

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The views, experiences, and referral patterns of Victorian fertility specialists regarding fertility enhancement by complementary and alternative medicine (CAM)

Infertility treatment is increasing in Australia and current trends in women’s age at first birth suggest more Australian couples may
need to seek assisted reproductive technologies (ART) to achieve parenthood. Over 60% of Australians are using complementary
and alternative medicines (CAM) as an option for a variety of health conditions, often without consultation with medical practitioners, potentially increasing the risk of drug interactions and adverse effects. There is very little data on the use of CAM in fertility enhancement (e.g. extent of use; costs; women’s willingness-to pay; what CAM modalities are commonly used; and what proportion of medical fertility specialists refer to CAM practitioners), and limited knowledge of potential side effects of many CAM products, particularly with respect to their use in the periconceptional period. There have been calls for further research into the use of CAM within Australia and elsewhere to provide much needed evidence, for integration of CAM with orthodox obstetrics and gynecology and for consideration by infertility specialists. This descriptive study aims to increase our understanding of women’s use of CAM in conjunction with conventional medical therapies to enhance fertility by ascertaining the views, experiences and referral practices of Victorian infertility specialists. All medical specialists approved under the Infertility Treatment Act 1995 and listed with the Infertility Treatment Authority (ITA) to practice in Victoria (n=55) will be invited to complete an anonymous postal survey.

FUNDING: La Trobe University Faculty of Health Sciences Research Grant 2008
STATUS: Ethics application submitted

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Comparing Standard Maternity care with One to one midwifery Support (COSMOS): A randomised trial

Helen McLachlan, Della Forster, Mary-Ann Davey, Judith Lumley in collaboration with Lisa Gold, School of Social Health and
Development, Deakin University; Tanya Farrell and Jeremy Oates, Royal Women’s Hospital; Ulla Waldenström, Karolinska Institute; and
Leah Albers, University of New Mexico

Continuity of carer in the provision of maternity care has been strongly recommended and encouraged in Victoria and throughout
Australia. The Victorian Department of Human Services (DHS) released a policy document “Future directions for Victoria’s
maternity services” in June 2004 which endorsed and promoted the expansion of public models of maternity care that offer continuity of carer. Many hospitals have responded by introducing caseload midwifery, a one to one midwifery model of care in which women are cared for by a primary midwife throughout pregnancy, birth and the early postnatal period. However, this model of care has yet to be subjected to rigorous evaluation. “One to one midwifery” or caseload care is being implemented
under trial conditions at the Women’s initially, with the possibility of one or two other sites also joining the trial. We will evaluate whether caseload midwifery decreases a number of interventions during childbirth (such as caesarean births, instrumental vaginal births, and induction of labour) compared with standard maternity care.

We will also compare a range of other outcomes such as perineal trauma; postnatal depression; maternal satisfaction with care;
initiation and duration of breastfeeding; costs; health outcomes for mothers and babies; and the impact of this new model on midwives and other staff in the organisation. Two thousand women at low risk of medical complications will be recruited to the COSMOS trial. We commenced recruitment in September 2007 and to date 206 women have agreed to participate.
This opportunity to conduct a randomised controlled trial in a large maternity hospital and possibly a smaller suburban hospital
is unique. The results are urgently needed and will assist policy makers and maternity services in planning for future models of
maternity care. This study will be the first randomised controlled trial in Australia of caseload midwifery care.

FUNDING: NHMRC project grant (2007-2010)
STATUS: Trial commenced, recruitment underway

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A review of postnatal hospital care in Victoria (PinC)

Della Forster, Judith Lumley and Jo Rayner in collaboration with Helen McLachlan, Division of Nursing and Midwifery, La Trobe University; andJane Yelland, Healthy Mothers, Healthy Families, Murdoch Childrens Research Institute

A decade of Victorian research has found low levels of satisfaction with the hospital stay following birth. Little was known about how
hospital postnatal services are organised, what guides the provision of care and how maternity units approach maternal health issues, including breastfeeding support and early responses to postnatal depression.

PinC (Postnatal in-hospital Care: a review) was conducted in 2004with two major stages of data collection – a survey of all public
maternity hospitals and interviews with key informants. Sixty-six hospitals participated in the survey, a response fraction of 96%.
Over forty interviews were conducted with managers, midwives and medical practitioners working in a range of large and small, rural and metropolitan maternity hospitals across Victoria.

There was great diversity in the provision of postnatal care across Victoria with differences in models of care, staffing arrangements,
physical facilities and routine practices. Overall, care providers were enthusiastic about postnatal care, and committed to ensuring this care was of high quality. However, there was a strong sense that the provision of early postnatal care is considered a lower priority compared to other episodes of maternity care. A final report of the PinC Review findings was launched in May 2005 in conjunction with a seminar on early postnatal care. The review has provided valuable information on the way public hospital postnatal services are provided in Victoria, what constrains care and innovations in service delivery. Importantly the PinC Review has assisted in our understanding of new possibilities that will inform the development and evaluation of interventions to improve care.

FUNDING: The William Buckland Foundation Grant 2003/4; Telstra Foundation Community Development Fund Grant 2004
STATUS: Final report published, two papers published and another two in press

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A review of postnatal care in the Victorian private hospital sector (PinC Private)

Jo Rayner and Della Forster in collaboration with Helen McLachlan and Louise Peters, Division of Nursing and Midwifery, La Trobe University; and Jane Yelland, Healthy Mothers, Healthy Families, Murdoch Childrens Research Institute

The first review of postnatal care from the perspective of public hospital care providers (PinC) was undertaken in 2004 and
involved a survey of public maternity facilities in Victoria and interviews with key informants from selected hospitals. The findings
revealed a diversity of practices in the provision of care across the State, including differences in the organisation of care, staffing
arrangements, facilities and routine practices. Barriers to provision of high quality postnatal care were also identified including the
busyness of the units, the inadequacy of staff-patient ratios, and the priority given to other episodes of care.

Given that approximately one third of Victorian births occur in the private sector a review of postnatal care in the private sector
(PinC private) was undertaken in 2006 to provide a comprehensive understanding of the structure and provision of postnatal care in
Victoria. A postal questionnaire was sent to all private hospitals (n=19) providing maternity services and in-depth interviews were
conducted with care providers (n=11) at selected regional and metropolitan hospitals. While the response rate was lower in the
private sector (14/19 hospitals, 76%), the postal survey revealed similar barriers to the provision of postnatal care highlighted in
the public review, despite some major differences in the staffing arrangements. Preliminary analysis of the interviews suggests a
mismatch between the expectations of postnatal care of women and midwives, with doctors who are seen as responsible for maternitycare in the private sector.

It is anticipated that the findings will highlight successes, gaps and concerns in service provision as well as provide important
background information to plan, implement and evaluate interventions to improve in-hospital postnatal care.

FUNDING: La Trobe University Faculty of Health Science Research Grant 2006, MCHR Grant 2006
STATUS: All data collection complete; analysis complete; paper on findings and minor thesis drafted; two presentations of findings at a conference 2007

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A review of postnatal care documentation in Victoria

Della Forster and Jo Rayner in collaboration with Helen McLachlan and Tracey Savage, Division of Nursing and Midwifery La Trobe University

Previous research has demonstrated low levels of satisfaction with postnatal care among recent mothers and clinicians alike.
As documentation is likely to have a significant influence on the provision of postnatal care, this study aims to analyse all postnatal
care documentation in Victoria.

Hospitals responding (80/88, 91%) to the state-wide surveys of postnatal care (PinC and PinC Private) were asked to provide any
documents used in the provision of postnatal care. All documents were categorised and analysed for content. Clinical pathways
were systematically reviewed using the Integrated Care Pathway Appraisal Tool (ICPAT). Providers’ comments relating to postnatal
documentation and clinical pathways collected in the surveys were also summarised to gain a more in depth understanding of the
documents in use.

A total of 1611 documents from 73 of the participating hospitals including: clinical pathways (n=146); educational material (n=776);
and other (n=689). There were over 100 unique sources of educational material for women, although only 10% were referenced
and 55% dated. There was a high level of duplication of clinical documentation of medication administration as well as neonatal
birth-weight and screening. Ninety percent of hospitals reported using clinical pathways and 131 different clinical pathways were
appraised. None met all appraisal criteria: 37% were task, not outcome focused; 9% could act as a decision support tool; 50%
promoted individualised care; and 38% were multidisciplinary.

Providers were generally supportive of clinical pathways, claiming they are useful and standardise care but that in practice inhibited
multidisciplinary communication. Comments involving general documentation for postnatal care were far less positive with
comments relating to poor documentation, excessive time demands and a general need for improvement. Preliminary findings suggest a state-wide approach may be required to regulate the quantity and quality of postnatal documentation and educational materials. This will minimise time and resource use, reduce areas of duplication, decrease costs and address risk management issues. It is also timely to redesign (using current evidence or ICPAT templates) and standardise or reconsider the role of clinical pathways in postnatal care and explore the impact they may have on individualised and multidisciplinary care.

FUNDING: None
STATUS: Preliminary findings presented at a national conference in 2007; final report is being drafted; and minor thesis (TS) underway

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An alternative approach to early postnatal care: a pilot study

Della Forster and Jo Rayner in collaboration with Helen McLachlan, Division of Nursing and Midwifery, La Trobe University; Tanya Farrell
and Tracey Savage from the Royal Women’s Hospital; Lisa Gold, School of Social Health and Development, Deakin University; and Jane Yelland, Healthy Mothers, Healthy Families, Murdoch Childrens Research Institute

A decade of Victorian research has identified women’s low levels of satisfaction with the hospital stay following birth and recent
Victorian state-wide reviews found that there were a number of barriers to care. Whilst the length of the hospital stay has declined
dramatically in Australia since the 1980s, pressure on hospital postnatal beds has increased, despite lack of rigorous evidence
regarding associated outcomes. We aim to determine the feasibility of implementing an adequately powered randomised controlled trial to investigate this issue.

We previously explored women’s views on postnatal care and the acceptability of alternative packages of care; women thought
postnatal length of stay needed to be individualised. We are therefore piloting an intervention that is more as the women
suggested: individualised flexible home-based early postnatal care, exploring feasibility, resource implications, and women’s and staff views and experiences.

Women expecting to give birth between November 2007 and March 2008 will be offered participation in mid-pregnancy until 100 women are recruited. Women are introduced to the concept of early home based care, with length of stay inversely proportional to number of home midwife visits, to a maximum of 5 home visits with discharge less than 12-24 hours (or 48 hours following a caesarean birth).

Women are seen again at 36 weeks to discuss their individual plan. Women will be asked to complete questionnaires at recruitment
and 8 weeks postpartum. Obstetric data will be obtained from the medical record. Focus groups and interviews will explore midwives’ views. An economic evaluation is being undertaken.

FUNDING: La Trobe University Faculty of Health Sciences Research Grant 2007; grant to the Royal Women’s Hospital from the Victorian Department of Human Services
STATUS: Recruitment continuing, data collection underway

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Alternative approaches to early postnatal care: exploring women’s views

Della Forster and Jo Rayner in collaboration with Helen McLachlan, Division of Nursing and Midwifery, La Trobe University; Lisa Gold,
School of Social Health and Development, Deakin University; Jane Yelland, Healthy Mothers, Healthy Families, Murdoch Childrens
Research Institute; and Sharon Rayner as part of the Public Health Trainee program
There is growing evidence from Australia and overseas that the care

provided in hospital in the early postnatal period is less than ideal forboth women and care providers. In addition, in many health services in Victoria, particularly metropolitan, the pressure on hospital beds has increased, and the physical space available to care for mothers and their babies may be limited. Many services, especially tertiary referral hospitals, have had to respond by discharging women much earlier than planned or expected, often with little or no preparation during pregnancy.

We conducted eight focus groups and four individual interviews in both rural and metropolitan areas of Victoria, to explore women’s preferences for postnatal care and the acceptability of proposed alternative packages of care. Proposed packages related for the most part to a shorter length of hospital stay with various care options.

Participants did not generally respond favourably towards the packages that were suggested; they felt the packages would not
provide the level of care that they expected. Many suggested that postnatal care needed to be flexible to meet the needs of each
individual. Women’s main concerns related to a shorter length of stay, especially for first time mothers. Generally, participants did not believe that domiciliary visits compensated for the perceived security of staying in hospital. The women in this study were of the view that being in hospital during the first days after the birth of their baby was safer for the baby than if they were home. Many lacked confidence in themselves as new mothers regarding their ability to care for their baby. There was a consistent view that the physical presence and availability of professional support helped alleviate these concerns, and this was especially the case for women having a first baby.

Women understandably have concerns about any moves to shorten the length of the postnatal hospital stay, they do not believe that increased domiciliary visits can compensate for forgoing the perceived security and value of staying in hospital. It is crucial that
women’s concerns and needs be considered when service delivery changes are planned and important that any move towards a
shorter postnatal length of stay is evaluated, in terms of the physical and mental health of both mother and baby, and the mother’s
satisfaction with the care received.

FUNDING: La Trobe University Faculty of Health Sciences Research Grant 2006, MCHR grant 2006
STATUS: Data collection and analysis complete; report disseminated and two papers submitted and under review

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PinC ANEW: supporting women after childbirth

Della Forster and Jo Rayner in collaboration with Helen McLachlan and Rebecca Collins, Division of Nursing and Midwifery, La Trobe
University; Kelsey Hegarty and Jane Gunn, Department of General Practice, University of Melbourne; Jane Yelland and Stephanie Brown,
Healthy Mothers, Healthy Families, Murdoch Childrens Research Institute; Lisa Love and Margie Cass, Mercy Hospital for Women;
and Jenny Kelly, Barwon Health

An alternative approach to psychosocial risk screening which focused on advanced communication skills for midwives and doctors was recently implemented as a six-month education program (ANEW) and evaluated using a before/after design. The program evaluation showed that midwives and doctors self-reported comfort and competency when identifying and caring for women with psychosocial difficulties increased. In the recent Victorian state-wide review of hospital postnatal care (PinC), 55% of key informants raised the issue that some midwives are not comfortable dealing with psychosocial issues.

The PinC review recommended that an ANEW style program be considered for staff who care for women during the postnatal period. Given the context of the postnatal environment, women’s low ratings of satisfaction with care, limitations of psychosocial risk screening, and the challenges for care providers in dealing with sensitive issues, a re-emphasis on an individual needs-based approach is likely to be beneficial to women after childbirth. A new approach to postnatal care focusing on advanced communication skills of midwives and nurses may also improve women’s satisfaction with care and enhance women’s comfort in disclosing psychosocial issues with the potential to impact on other health outcomes such as breastfeeding. In 2006 we redesigned the original ANEW program to make it suitable to the postnatal environment. The redesigned packages have been piloted
at two sites and evaluated using a before/after design.

FUNDING: La Trobe University Faculty of Health Sciences Research Grant 2006
STATUS: Data collection and analysis completed; minor thesis and one paper drafted

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Attachment to the breast and family attitudes towards breastfeeding (ABFAB) ISRCTN21556494

Judith Lumley, Della Forster, Helen McLachlan and Lisa Amir in collaboration with Christine Beanland, Nurses Board Victoria;
Dianne Earl, Kaye Dyson and Heather Harris, Royal Women’s Hospital; Roger Short, Department of Perinatal Medicine, Royal Women’s
Hospital; and Ulla Waldenström, Karolinska Institute, Sweden

ABFAB was a randomised controlled trial evaluating the effect of two educational interventions in the middle of pregnancy on the initiation and duration of breastfeeding. 981 women having their first baby, who were booked into The Royal Women’s Hospital (RWH) were enrolled in the project in mid-pregnancy (approximately 18 weeks), and randomly allocated to one of three
groups: a control group or one of two interventions - an antenatal breastfeeding class focused on practical aspects of breastfeeding and two antenatal breastfeeding classes that explored family attitudes to breastfeeding. Classes took place between weeks 20-25 of pregnancy.

All women had access to the standard childbirth education at the RWH. Recruitment to the study was between May 1999 and August 2001. Data were collected by questionnaire at recruitment, at interview in hospital after the birth and by telephone interview 6 months later, and completed in August 2002. Attendance at the ‘practical skills’ class was 66% (similar to attendance at standard childbirth education classes at the RWH) and the ‘attitudes’ class had 58% attendance for class one and 40% for class two.
Neither intervention increased breastfeeding initiation or duration compared to standard care. Breastfeeding initiation was 96% in
the ‘practical skills’ group, 94% in the ‘attitudes’ group, and 95% in the group allocated to standard care. Six months after birth, 53% of women in the ‘practical skills’ group, 47% of those in the ‘attitudes’ group and 52% of those allocated to standard care were feeding any breast milk. We conclude that in settings where breastfeeding initiation is already high, neither of the two interventions can be recommended as effective strategies to increase initiation or duration.

FUNDING: NHMRC Project grant 1998-2000, RWH scholarship 2002, VicHealth scholarship 2003-2005
STATUS: Trial completed, four papers published, one under review and two in preparation Mother & Child Health Research ANNUAL REPORT 2007

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Medications and breastfeeding women: knowledge, attitudes and practices of GPs

Lisa Amir and Jeanne Daly, in collaboration with Marie Pirotta, Department of General Practice, University of Melbourne; and Swee
Wong, Pharmacy Department, Royal Women’s Hospital At times, women who are breastfeeding will consider taking medicines. These may include complementary and over-the-counter as well as prescribed medicines. General practitioners (GPs) tend to rely on pharmaceutical companies for information about medicines.

The companies’ usual advice is to be cautious about prescribing medicines to breastfeeding women. However, there are very few
medicines which need to be used with caution while breastfeeding.

This study aims to investigate general practitioners’ knowledge, attitudes and practices about the use of medicines in breastfeeding
women. These issues will be explored with GPs using in-depth interviews with a small number (10-20) and a survey of a larger
group (over 700).

FUNDING: NHMRC Health Professional Research Fellowship 2006-2009 (LA), La Trobe University Faculty Health Sciences Research Grant 2007
STATUS: Ethics approval from La Trobe University and Royal Women’s Hospital; four interviews conducted and postal questionnaire sent

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