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Women's health

The clinical utility of routine urinalysis in pregnancy

To the Editor: Murray et al recently suggested that after an initial screening urinalysis, routine urinalysis could be eliminated from antenatal care without adverse outcomes for women.1 Their conclusions are based on a prospective observational study of 1000 women, 26 of whom developed pre-eclampsia, with 6/24 (25%) developing new proteinuria before the onset of hypertension. We have concerns about the authors' claims, which, we believe, are not justified by their findings. Pre-eclampsia remains a major cause of maternal and perinatal mortality.2 A study of 26 cases of pre-eclampsia is clearly underpowered to evaluate important morbidity and mortality outcomes. Therefore, one must place great emphasis on potentially undetected cases of pre-eclampsia, such as those that repeatedly appear as examples of substandard care in the Report on confidential inquiries into maternal deaths in the United Kingdom.3 That the initial screening urinalysis detected only 2/26 (8%) women who subsequently developed pre-eclampsia is no surprise. In contrast, routine urinalysis at antenatal visits detected 25% of cases of pre-eclampsia before the onset of hypertension. In the UK, this would amount to 4500 women per annum. The detection of proteinuria provokes further antenatal visits earlier than would normally be planned, facilitating early detection and management of pre-eclampsia. Intervals of 2–4 weeks between visits are usual in the early part of the third trimester when the risks to mother and fetus of severe early onset pre-eclampsia are greatest.4 By eliminating routine urinalysis from antenatal care, a quarter of affected women are potentially exposed to the risk of ongoing undetected pre-eclampsia for up to four weeks. Murray et al suggest that most women would be detected by risk assessment at the initial visit. While there are known risk factors for pre-eclampsia, the largest group who develop pre-eclampsia are primigravid women with no previous history of note. In addition, there are no reliable studies to justify this claim of Murray et al. Recent randomised controlled trials have suggested that the frequency of antenatal visits could be reduced without demonstrating harmful effects.5 None of these trials, however, have the power to demonstrate safety. Even the recent large World Health Organization trial involving 24 526 women6 would have required 490 000 women for 80% power, and 649 910 women for 90% power, to exclude the 40% increase in maternal mortality actually observed with reduced antenatal care. Changes in well-tried methods of antenatal care need to be assessed with more stringency before it is concluded that they are safe.

Deirdre J Murphy · Christopher W Redman

In reply: The clinical utility of routine urinalysis in pregnancy

In reply: We agree with Murphy and Redman that pre-eclampsia remains an important disorder and a major cause of maternal and perinatal mortality. However, we disagree with their interpretation of our data. Murphy and Redman allege that, by eliminating routine urinalysis, a quarter of cases of pre-eclampsia may remain undetected for up to four weeks. As we pointed out in our article,1 three of the six women who developed dipstick proteinuria before they developed pre-eclampsia were already considered "at risk" for pre-eclampsia — two because of multiple pregnancies and one with a history of prior pre-eclampsia. These women would, in our practice, continue to have routine urine tests during their pregnancies. The argument is then whether it is justifiable to undertake repeated urinalysis in almost 1000 women to detect three who have dipstick proteinuria, but no other warning signs before the onset of their hypertension. In practice, we would have had to increase antenatal clinic visits for 338 women with dipstick proteinuria (most of whom will have had false-positive results2) to detect these three women with proteinuria before they developed pre-eclampsia. It is already our normal practice for women to have antenatal visits every second week in their third trimester. Therefore, it is just as likely that their blood pressure changes would have been detected by our routine surveillance as by the knowledge that they had dipstick proteinuria. We did acknowledge clearly in our discussion that our study had a potential for type II error and that the best approach is a randomised controlled trial of outcomes between those who do and do not have continued urinalyses during pregnancy. None of this belittles the importance of pre-eclampsia, nor the need for us to separate women considered at "low risk" from those considered "at risk" for pre-eclampsia on the basis of well recognised risk factors. The latter group should never be considered among those in whom routine urinalysis can be omitted.

Mark A Brown · Caroline S E Homer · Gregory K Davis · George Mangos

Pap smear participation rates, primary healthcare and Indigenous women

To the Editor: As practitioners in a community-controlled Aboriginal and Torres Strait Islander primary healthcare centre, striving to better meet the healthcare needs of our community, we would like to offer some thoughts on a recent article by Coory et al.1 In reporting on cervical cancer screening participation rates in Indigenous communities in Queensland, Coory et al identified the communities but did not inform them that the study was being conducted. We feel that such an approach is unhelpful and reflects a paternalistic attitude. The accompanying editorial2 rightly drew attention to the lack of direct consultation with the communities involved and the consequences of this in terms of future interventions. Without a true partnership with the women and their communities, the authors were unable to do more than imply that participation rates were better in centres with a primary-healthcare approach to screening. Information about the types of services and choice of Pap smear providers available in each community, in addition to the Pap smear screening participation rate, would be of great interest. It would, in part, answer the question the authors themselves posed about the role of primary healthcare in improving Pap smear participation rates. Already scarce funds could then be committed to improving access to quality primary healthcare rather than to conducting further trials. A further factor, which was not explored in either the study or the editorial, was health promotion. The cornerstone of health promotion in the Indigenous community remains the "kit-video" model, comprising posters, leaflets and a video. In contrast, mainstream health promotion often involves expensive multimedia campaigns promoted by national celebrities. Such campaigns have been shown to increase Pap smear screening in the wider community.3,4 To date, these campaigns have rarely had an Indigenous focus, and it might be argued that a consequence of this is the low Pap smear participation rate documented by Coory et al. In our experience,5 the Indigenous community does respond to culturally appropriate holistic primary healthcare. The study by Coory et al demonstrates a lack of commitment, collaboration and innovation — essential features for the delivery of quality primary healthcare — that is all too common in the current approach to Indigenous health.

Katie S Panaretto · Sarah Larkins · Vivienne Manessis

In reply: Pap smear participation rates, primary healthcare and Indigenous women

In reply: Black has argued that the role of evidence in policy development is to create concern and set agendas.1 This was the aim of our article. Although there has been a national, organised approach to preventing cervical cancer since 1991, our study found that screening rates for Indigenous women still lag well behind those of non-Indigenous women. Workers in Indigenous health might have suspected as much, but valid data have not previously been available for a wide geographical area. As Murray and Lopez point out, the lack of good data on a health issue is often taken to mean that the problem is not important.2 We agree that the development of effective programs should be done in consultation and partnership with Indigenous communities. However, there is an additional need to influence decision-makers and budget-holders at national, State and regional levels. An evidence base that identified effective interventions would facilitate this process. Such evidence need not come from randomised controlled trials. On the other hand, case reports of successful interventions in a single community that cannot be sustained when key personnel leave are not very persuasive. It is also useful to demonstrate that the situation is not hopeless. The encouraging finding from our study was that the participation rate in cervical cancer screening was more than 50% in three of the 13 communities studied.

Michael D Coory · Patricia S Fagan · Jennifer M Muller · Nathan AM Dunn

Women's health Clinical update 21 April 2003 Free

Management of common vulval conditions

Community-based surveys indicate that about a fifth of women have significant vulval symptoms lasting over three months at some time in their lives. Common causes of itch or pain are dermatitis, recurrent candidiasis and the recently recognised pain syndromes — vulvar vestibular syndrome and dysaesthetic vulvodynia. Diagnosis is usually apparent after a thorough history and examination, although conditions commonly coexist and are complicated by prior treatment. Skin lesions not responding to treatment require biopsy. Treatment aims to control symptoms rather than to cure; avoiding soaps and other irritants is central to management. An early, accurate diagnosis should enhance management of vulval conditions, particularly pain syndromes.

Belinda M Welsh FACD · Karen N Berzins DRANZCOG, Dip Ven · Kathy A Cook FRACOG · Christopher K Fairley FRACP, PhD

Women's health Letters 21 April 2003 Free

Hormone replacement therapy after a diagnosis of breast cancer: cancer recurrence and mortality

To the Editor: We urge caution about the recently published findings of Durna and colleagues on use of hormone replacement therapy (HRT) by breast cancer patients.1 They found no increase in risk of breast cancer recurrence or reduction in life expectancy in women using HRT after treatment for primary breast cancer, leading them to conclude that HRT seems a safe treatment for women with a history of breast cancer. We believe that their study has many limitations and consequently their conclusions are unfounded Durna's group conducted a retrospective, observational study using unmatched patient groups. The HRT group was statistically younger, with smaller tumours and fewer positive nodes, and thus had better prognosis. The authors discussed regression analyses for age of diagnosis and stage to reduce potential bias, but did not include these data. The omission of tumour grade and receptor status in the analysis is an obvious flaw. The mean duration of HRT use was short compared with many previous studies (mean, 1 year). This is particularly important, as any risk is likely to be cumulative.2 There were also statistically more women in the HRT group who had received HRT before diagnosis, and for a longer duration (mean, 6.5 years v 3 years). This too may bias results, as breast cancer that develops after HRT has been suggested to carry a better prognosis.3 There was also no subgroup analysis of those who took concomitant tamoxifen. Durna and colleagues also do not address the concerns raised by the Women's Health Initiative study, which showed an excess of cardiovascular and thromboembolic events in "healthy" women taking HRT.4 Many of these events occurred in the first years of HRT use, the time assessed in Durna's study. The risks of short-term HRT in breast cancer patients may be not only tumour-related, but may also include cardiac and thrombotic events, which were not specifically considered by Durna and colleagues. Of additional concern is the extensive portrayal in some sections of the media that this study is conclusive regarding the risks of HRT use by women with breast cancer. The importance of correct media interpretation of studies is discussed in the accompaning editorial by Patel and colleagues.5 Despite this editorial and the inadequacies of Durna's study, the results of this study, released through the media, inaccurately suggested safety and even a possible benefit of HRT.6 This simply adds to the "HRT furore". All studies addressing this issue to date have been small and non-randomised, often with no control group or unmatched groups.2 Because of these limitations, no clear recommendation can be made about the safety of HRT in women with breast cancer. Until results are available from rigorous randomised controlled trials, such as the ongoing HABITS (Hormone Replacement Therapy After Breast Cancer — Is It Safe?) study (IBCSG 17-98), we should not be "advocating" HRT to breast cancer patients. For Durna's group to suggest otherwise is very premature. In addition, there are well studied, effective alternatives to HRT for treating menopausal symptoms in breast cancer patients (eg, venlafaxine),7 and these would seem the current safer option.

Theresa M Hayes · Craig R Underhill · Kerrie Clarke · Martin HN Tattersall

Women's health Letters 21 April 2003 Free

In reply: Hormone replacement therapy after a diagnosis of breast cancer: cancer recurrence and mortality

In reply: We feel that Hayes and colleagues repeat the editorial comments of Dixon1 that accompanied our article.2 Our investigation, being retrospective, had biases and limitations normally associated with that type of study. In the third and fourth paragraphs of the discussion section of our article, we examined further the sources of bias and their impact. Hayes and colleagues state that the omission of tumour grade and receptor status from our analysis is a flaw. We agree that including these variables would have made our study more complete, even if we doubt that this would have altered the conclusions. So many of these data were missing that statistical analysis would have been unreliable. As was stated in the methods section, the analysis was adjusted for the covariate HRT use before diagnosis. Tamoxifen use was very similar among HRT users and non-users (58% and 60%, respectively), and any bias introduced by this difference would be insignificant. The scope of our article, as suggested by its title, was limited to the issue of cancer recurrence and mortality. We did not specifically investigate the impact of HRT on cardiovascular and thromboembolic events. Nonetheless, if car-diovascular disease had increased mortality, this would have been apparent as an increase in all-cause mortality. We agree with Hayes and colleagues that it is vital that the media interpret studies correctly for the general public. We are disappointed that Hayes and colleagues have misinterpreted our conclusion. Our article does not advocate HRT use by women with breast cancer. We explicitly stated that "These results need to be confirmed in a randomised trial before HRT can be advocated for all women who have had breast cancer." Furthermore, ". . . the observed association between HRT use and [reduced] risks of breast cancer recurrence and death cannot be inferred to be causal". We believe that we are justified in our conclusion that HRT use in women diagnosed with breast cancer is not associated with an increased risk of recurrence of breast cancer or a shortened life span. It is our clinical practice to use HRT only when alternative therapy fails.

Eva M Durna · Barry G Wren · Gillian Z Heller · Leo R Leader · Peter Sjoblom · John A Eden

In reply: Low-molecular-weight heparins and heparinoids

In reply: Walters and Graham question the role of low-molecular-weight heparin (LMWH) as a replacement for unfractionated heparin during pregnancy, and cite the lack of randomised comparisons to support their view that the standard initial treatment for pulmonary embolism during pregnancy remains intravenous unfractionated heparin. We do not deny the lack of clinical trials of LMWH in pregnancy; we were simply referring to the increased use of LMWH.1,2 However, the lack of evidence of effectiveness does not equate with evidence of lack of effectiveness of LMWH in pregnancy. Clinical trials are needed to determine optimal anticoagulant strategies during pregnancy, particularly in patients with prosthetic heart valves. While awaiting the results of these trials, we believe that the major pharmaco-kinetic and safety advantages of LMWH over unfractionated heparin, coupled with an extensive body of evidence demonstrating their efficacy and safety in non-pregnant patients, should not be ignored in our pursuit of optimal anticoagulation therapies. Williamson and Street question the validity of asymptomatic deep vein thrombosis as a surrogate for symptomatic venous thromboembolism in patients undergoing major orthopaedic surgery. Further, they cite a 0.1%–0.2% incidence of pulmonary embolism in patients undergoing hip replacement surgery without prophylaxis3 to support the conclusion that any effect of thromboprophylaxis on reducing symptomatic events is likely to be irrelevant for individual orthopaedic surgeons. We believe that their argument is seriously flawed. Firstly, the "meta-analysis" they cite3 had major methodological limitations, as elegantly highlighted by "Sherlock Holmes" in his critical appraisal of systematic reviews of surgical thromboprophylaxis.4 Secondly, rigorously conducted randomised trials and meta-analyses of randomised trials have demonstrated the efficacy of antithrombotic therapy for the prevention of both symptomatic and fatal venous thromboembolism in high-risk surgical patients, including lower-limb orthopaedic surgery.5,6 Thirdly, the clear correlation between reduction in asymptomatic and symptomatic venous thromboembolism in patients undergoing elective joint replacement surgery7 suggests that asymptomatic thrombosis detected by screening venography is a valid surrogate for symptomatic events. Fourthly, we agree that an individual orthopaedic surgeon performing 50 joint replacements per year may remain unaware of a small reduction in fatal pulmonary emboli in his or her own practice (eg, a 0.1% absolute risk reduction would be equivalent to preventing one death in 20 years of practice). Yet, on a population basis, even a 0.1% absolute reduction (which is likely to be an underestimate — the PEP study showed a 0.3% absolute reduction in fatal pulmonary embolism with aspirin5) equates to 50 preventable deaths per year in Australia alone8 and many thousands worldwide. There is now overwhelming evidence of the efficacy of thromboprophylaxis for preventing venous thromboembolism, including symptomatic and fatal pulmonary embolism, in high-risk surgical patients. With the rapid ageing of the Australian population and the expected increase in joint replacement surgery in coming years,9 the failure to use effective thromboprophylaxis in orthopaedic patients will likely result in a growing burden of preventable morbidity and mortality from venous thromboembolism.

John W Eikelboom · Graeme J Hankey

Women's health Research 17 March 2003 Free

The effect of female age on the likelihood of a live birth from one in-vitro fertilisation treatment

Objective: To determine the chance of at least one live birth from one round of in-vitro fertilisation (IVF) treatment and the effect of the woman's age on that likelihood.Design: Retrospective analysis of outcomes from IVF treatment that did not involve donated gametes, but which included embryos cryopreserved in the retrieval cycle.Setting and patients: All IVF patients (median age, 36 years; range, 22–48 years) who attended a private IVF clinic in Sydney for an egg retrieval between 1 January 1998 and 31 December 1998, and had embryo placements (fresh and cryostored) performed up to 30 June 2001.Main outcome measure: Independently audited live births surviving the neonatal period.Results: 565 women had 648 egg retrievals during the period. The age of peak utilisation of IVF was 39 years. For women aged 34 years or less, the chance of a live birth from one round of egg retrieval and IVF treatment was 52.4% (95% CI, 47%–59%). For women aged 35–44 years, there was a linear decline in the live birth rate, and no babies were born from retrievals at age 45 years and over. There was an age-dependent rise in the frequency of miscarriages, from 10.5% (95% CI, 5%–18%) for women under 35 years, to 16.1% (95% CI, 9%–25%) for those 35–39 years, and 42.9% [95% CI, 24%–63%] for those over 40 years (P < 0.001). A third of the first births resulted from embryo transfers performed after a period of cryostorage.Conclusion: As fertility with IVF falls from the age of 34 years, and the age of peak IVF utilisation is 39 years, many Australian women are seeking IVF at an age when the likelihood of a live birth is reduced.

Robert P S Jansen MD, FRACP, FRANZCOG, CREI

Women's health Letters 17 March 2003 Free

How much cervical cancer is being prevented?

To the Editor: It was estimated in 1989 that cervical screening in Australia was preventing only 46% of squamous malignancies, against a theoretical capacity of 90%.1 This suboptimal achievement after almost 25 years of cervical screening led to a major reorganisation of the program. The 1989 analysis has been repeated, using the most recent year (1998) for which incidence rates have been published (Box). The more recent figures suggest that cervical screening in Australia is now preventing 70% of squamous carcinoma of the cervix. This remarkable improvement can probably be attributed to the improved participation by women in regular screening, improved standards within laboratories, and better follow-up of cytological abnormalities. While there is still scope for improvement, there is clear evidence of a substantially better gain from cervical screening. Continued efforts to increase the participation rate among women aged 60–69 years is appropriate given that the prevented proportion appears to be lower in this age range. Percentage of squamous carcinoma of the cervix prevented, by age group, Australia 1998 Age group Number of women (estimated number with a cervix*) in Australia2 Expected rate (per 100 000 women) of squamous carcinoma without screening† Expected number of squamous carcinomas‡ Estimated number of squamous carcinomas observed in 1998§ Percentage prevented 20–24 665 691 (665 025) 5 33.3 9.6 71.1% 25–29 733 145 (732 412) 15 109.9 34.8 68.3% 30–34 706 925 (687 838) 25 172.0 62.9 63.4% 35–39 748 913 (728 692) 45 327.9 74.7 77.2% 40–44 702 629 (608 477) 45 273.8 76.2 72.2% 45–49 649 539 (562 501) 45 253.1 81.4 67.8% 50–54 570 287 (410 607) 45 184.8 48.1 74.0% 55–59 431 183 (310 452) 45 139.7 40.7 70.9% 60–64 370 123 (251 314) 45 113.1 40.7 64.0% 65–69 348 707 (236 772) 45 106.6 44.4 58.3% Total 5 927 142 (5 194 090) 1714 514 70.0% * Calculated by multiplying the number of women in Australia by the estimated age-specific hysterectomy fractions.3 † Methodology as for the study by the International Agency for Research on Cancer,4 using incidence in Norway at a time when the rates would have been little affected by screening. ‡ Calculated by multiplying the estimated number of women in Australia with a cervix by the expected rate of squamous carcinoma of the cervix in the absence of screening.4 § Calculated by multiplying the number of cases of cervical cancer observed in 1998 by 0.74, which was the proportion of all cervical cancers that were squamous.5

Heather S Mitchell

Women's health EBM in action 3 March 2003 Free

Is physiotherapy an effective treatment for lymphoedema secondary to cancer treatment?

Clinical questionA physiotherapist at Monash Medical Centre wanted to know the most effective physiotherapy treatments for lymphoedema following treatment for breast cancer. Search questionPeople undergoing physiotherapy for lymphoedema formed the patient group of interest. Clinical outcomes were reduction or prevention of lymphoedema. A randomised controlled trial comparing physiotherapy treatment to no treatment, placebo, or other conservative treatment would be the most appropriate study design. SearchThe search term "lymph(o)edema" was combined with the general treatment search terms "physical therapy", "physiotherapy", "conservative treatment", "non-invasive treatment" and the more specific treatment terms "complex physical therapy", "compression sleeve/bandaging/garment", "manual lymphatic drainage", "mechanical compression" to identify all English-language controlled trials, meta-analyses and systematic reviews published between January 1970 and August 2000. We electronically searched the Cochrane Library, Best Evidence, MEDLINE, Cumulative Index of Nursing and Allied Health Library (CINAHL), Current Contents and the Physiotherapy Evidence Database (PEDro). We also searched the websites of 12 relevant health organisations, including the National Guidelines Clearinghouse, National Breast Cancer Centre, and Agency for Healthcare Research and Quality. Summary of findingsOur search identified two systematic reviews,1,2 and five randomised controlled trials3-7 and one non-randomised controlled trial8 published subsequently to, or not included in, the systematic reviews. There are few well-designed randomised controlled trials that examine the effectiveness of physical therapies for lymphoedema. The two identified systematic reviews1,2 included uncontrolled studies with methodological problems, and their conclusions cannot be confidently endorsed. Furthermore, as no single validated and widely acceptable outcome measure is available, comparison of results across trials or pooling of results in a meta-analysis is not appropriate. Some conclusions can be drawn by examining the controlled studies included in the systematic reviews, and the subsequently published randomised3,4 and non-randomised8 controlled trials. While there is some evidence that compression garments reduce limb swelling, the addition of other modalities, including multilayer bandaging,4 manual lymphatic drainage,3,8 pneumatic pumps or electrical stimulation,1 does not provide additional benefit. However, one randomised controlled trial found that compression sleeves provided only short term benefit (over four weeks),6 while the remaining randomised controlled trials reported that compression was no more effective than manual lymphatic drainage7 or no active treatment5 to reduce lymphoedema. The randomised controlled trials of Dini et al5 and Hornsby6 illustrate the importance of appropriate control groups. Both reported that adherence to skin-care guidelines and other self-care protocols reduces lymphoedema as effectively as the addition of active treatment. Although the International Society of Lymphology9 recommends complex physical therapy (skin hygiene, lymph drainage, bandaging, and exercises in treatment and maintenance phases) as the initial treatment for lymphoedema, we found no rigorous evidence to support this. OutcomeSubsequently published evidence-based clinical practice guidelines10 support our findings, namely that compression garments are of some but limited value, although they are as effective as other, more resource-intensive methods. Other physical therapies, such as complex physical therapy, pneumatic pumps, rigorous massage and compression bandaging, require further rigorous evaluation before recommendations about their use can be made. These recommendations were incorporated into a lymphoedema service for women in south-east Melbourne.

Renea V Johnston PhD · Jeremy N Anderson MD, FRANZCP · Barbara L Walker BAppSci(Phty), GradDipHealthAdmin

Women's health Letters 3 March 2003 Free

Lymphoedema in breast cancer patients

To the Editor: It has been known for a long time that washing soda (crystalline sodium carbonate) is effective for removing fluid from joint effusions. The crystals are simply wrapped in a tea towel, crushed with a rolling pin and wrapped around the joint overnight. In the morning the sodium carbonate is rock solid and the joint effusion has markedly improved. I was discussing with one my patients her problem of gross upper-limb lymphoedema after surgery and radiotherapy for breast cancer to the axilla. She went home and made an appropriate pack of sodium carbonate, which she wears overnight. She can now use her arm throughout the day. Obviously, the lymph fluid reaccumulates because her lymphatic system is well and truly obstructed. This patient spoke to several other patients in the Day Centre at the Monash Medical Centre, who tried this in addition to other exercises for lymphoedema, and they have found it to be extraordinarily effective. One woman had gross oedema of her hand, which rendered it useless: she simply immersed her hand in a solution of sodium carbonate and thus dialysed the fluid from her hand. Thereafter she could use her hand for 12 hours before significant amounts of fluid reaccumulated. While this is obviously not the perfect solution to lymphoedema in patients with breast cancer, anything that may help them is worth noting. Perhaps a suitable linen device could be made which would cover the whole arm at night. Evidence for the use of this simple dialysis treatment is currently anecdotal. It might be appropriate to design a clinical trial to determine whether this method has potential in treating this extremely troublesome form of lymphoedema.

Graeme N Brodie

Women's health Medicine and the community 3 February 2003 Free

Embryo donation at an Australian university in-vitro fertilisation clinic: issues and outcomes

Objectives: To review the choices of couples relinquishing frozen embryos and the outcomes of embryo donation at a major in-vitro fertilisation (IVF) clinic.Design and setting: Retrospective audit of 11.5 years of data (1991–2002) from the Monash University IVF clinic, Melbourne.Participants: Couples who make decisions regarding the fate of their frozen embryos, and recipient couples taking part in embryo adoption.Main outcome measures: Couples' choices with regard to the fate of their frozen embryos, and the outcome of donated embryo treatment cycles.Results: Of 1246 couples relinquishing frozen embryos, 1116 (89.5%) opted to discard rather than donate their embryos. Sixty-six per cent of donated embryos survived thawing. From donated-embryo transfer to 50 women in 92 cycles, a 17.4% pregnancy rate per transfer cycle was achieved, and 10 women delivered 11 healthy babies at term. At the time of our audit there were 98 couples on the waiting list to adopt embryos.Conclusions: It is worth considering how couples can be encouraged to donate rather than discard their surplus frozen embryos. An educational program on relevant legal, social and clinical issues may facilitate this.

Gabor T Kovacs MD, FRANZCOG · Sue A Breheny BSc(Hons) · Melinda J Dear BAppSc

History and humanities History 9 December 2002 Free

"The contagiousness of childbed fever": a short history of puerperal sepsis and its treatment

The death of a friend solved a centuries-old, oft-fatal mystery My doctrine is produced in order to banish the terror from lying-in hospitals, to preserve the wife to the husband, and the mother to the child... — Ignaz Semmelweis, 1861 Today, a very large proportion of women giving birth receive antibiotics, potent and sometimes in combination, during their accouchement. Routine prophylaxis is widely accepted for caesarean sections, which account for 20%–25% of deliveries.1 Of course, any pregnant woman presenting with an obvious infection will automatically receive an antibiotic. Further, so will most pregnant women with membranes ruptured for any length of time, either before or after labour begins, and any woman in labour with a raised temperature. There is also a more relaxed approach to many former midwifery routines — for example, the abandoning of masks and gowns and the admission of several support people to the delivery scene — which could diminish both younger obstetricians' and midwives' appreciation of the potentially deadly risk of puerperal infection. However, until relatively recently in developed countries, and still in many developing countries, puerperal sepsis was and is a killer.2 Fatal feverImmediately postnatally, the placental site is a large open wound — easily invaded by ascending bacteria. For thousands of years, it was recognised that puerperal women were at risk of a fever that could be fatal. The Hippocratic writings contain references to childbed fever, as do some Hindu texts dating back to 1500 bc.3 Moreover, the potential for birth attendants to initiate such infections seems to have been comprehended by some of the ancient writers, including the Greek physician Soranus, and the Hindus, since advice on hygiene for birth attendants was offered.3,4 Triptych showing the Hôtel Dieu in Paris, about ad 1500. The comparatively well patients (on the right) were separated from the very ill (on the left). Note there were always two patients to a bed. Nevertheless, in ancient and medieval times, mortality from puerperal sepsis was apparently relatively low, as women generally gave birth at home. Peculiar to the puerperium?The 17th century saw the establishment of "lying-in" hospitals in many European cities. While these institutions were, in some ways, an advance — in particular, by relieving obstructed labour with forceps or intrauterine manipulation — the crowding of patients, frequent vaginal examinations and the use of contaminated instruments, dressings and bedlinen spread infection in an era when there was no knowledge of antisepsis. The first recorded epidemic of puerperal fever occurred at the Hôtel Dieu in Paris in 1646. Subsequently, maternity hospitals all over Europe and North America reported intermittent outbreaks, and even between epidemics the death rate from sepsis reached one woman in four or five of those giving birth.5 Numerous bizarre theories as to the cause of childbed fever were expounded — among them that it was due to a "miasma", or the labouring woman's disturbed state of mind, or mechanical pressure from the distended uterus. Certainly, childbed fever was universally regarded as a condition peculiar to women in labour.6 Sepsis suspectedContagion as the basis for childbed fever was first suspected by a number of British physicians in the late 18th and early 19th centuries.7 The name of Thomas Watson, Professor of Medicine at King's College Hospital, London, is not well known, but in 1842 he wrote: "Wherever puerperal fever is rife, or when a practitioner has attended any one instance of it, he should use most diligent ablution." Watson recommended handwashing with chlorine solution and changes of clothing for obstetric attendants — everything, he said, "to prevent the practitioner becoming a vehicle of contagion and death between one patient and another." Unfortunately, Watson's advice seems to have been largely ignored by obstetric practitioners of the time — the contagion theory is completely absent from contemporary obstetric texts.7 Oliver Wendell Holmes Across the Atlantic, in Boston, Dr Oliver Wendell Holmes — pathologist, physician and president of the Boston Society for Medical Improvement — developed an interest in the condition after two related cases were presented to his society. A physician and a medical student both died of septicaemia after performing an autopsy on a woman who died of puerperal fever. Holmes read the existing literature, and became convinced that the condition was highly contagious, and that doctors, nurses and midwives were the active agents of its spread. He began to speak and write on the subject, and in 1843 published his classic essay The Contagiousness of Puerperal Fever.8-10 The essay contains eight rules for the obstetrician, which included not only handwashing and changes of clothing, but also the avoidance of autopsies if obstetric cases were being managed. Holmes' conclusions were ridiculed by many of his prominent contemporaries. For example, Charles Meigs, a well-known obstetrician, was incensed at the suggestion he may himself be transmitting disease. "Doctors," he said, "are gentlemen, and gentlemen's hands are clean."10 Connection comprehendedMeanwhile, in Vienna, Dr Ignaz Semmelweis, a native of Hungary, was beginning a life-long obsession with finding the cause of, and preventing, puerperal fever. However, knowing no English, and far from North America, Semmelweis was unaware of the work of Holmes. Ignaz Semmelweis In 1844, Semmelweis was appointed assistant lecturer in the First Obstetric Division of the Vienna Lying-In Hospital, the division in which medical students received their training. He was appalled by the division's high mortality rate from puerperal fever — 16% of all women giving birth in the years 1841–1843. In contrast, in the Second Division, where midwives or midwifery students did the deliveries, the mortality rate from the fever was much lower, at about 2%. Semmelweis also noted that puerperal sepsis was rare in women who gave birth before arriving at the hospital.6,11 Over the next few years, Semmelweis studied and rejected numerous hypotheses. He did note that medical students and doctors from the First Division performed autopsies each morning on women who had died in the hospital the previous day and that midwives were not required to perform such autopsies. However, he did not immediately appreciate the connection between the two observations.6,11 In March 1847, Jakob Kolletschka — professor of forensic pathology, colleague and friend of Semmelweis — died of septicaemia after sustaining an accidental wound to the hand during an autopsy. On reading the report of Kolletschka's autopsy, Semmelweis was struck by the similarity of the pathological findings to those of women who had died of puerperal fever. He later wrote: "Suddenly a thought crossed my mind: childbed fever and the death of Professor Kolletschka were one and the same. His sepsis and childbed fever must originate from the same source . . . the fingers and hands of students and doctors, soiled by recent dissections, carry those death-dealing cadavers' poisons into the genital organs of women in childbirth . . .".6,11,12 Semmelweis began experimenting with various cleansing agents and, from May 1847, ordered that all doctors and students working in the First Division wash their hands in chlorinated lime solution before starting ward work, and later before each vaginal examination. The results were extraordinary — the mortality rate from puerperal fever in the division fell from 18% in May 1847 to less than 3% in June–November of the same year.11 Doctrine dismissedLike Holmes, Semmelweis found that his conclusions did not receive immediate acclaim from his colleagues and superiors. Indeed, he was treated with scepticism and ridicule by many in the Viennese and wider European medical establishments, including his own professor, Johann Klein. In 1849, Semmelweis' contract with the Lying-In Hospital was not renewed and he returned to Hungary, joining the University of Pest. He presented his findings to the Medical Society of Vienna in 1850. They were not well received, other opponents at that time including the famous pathologist Rudolph Virchow and the prominent obstetrician Friedrich Scanzoni. Semmelweis did not publish his observations until 1861; again, they were greeted dismissively. Embittered, Semmelweis wrote a series of "open letters" to his former professors, accusing them — rightly, as it turned out — of being "medical Neros" and "murderers".11,12 Sadly, his last years were affected by depression and mental disturbance. In July 1865, he was committed to a psychiatric institution in Vienna, and died there two weeks later — ironically, probably from septicaemia following a cut to a finger.3,6 Acceptance of antisepsisParadoxically, within a few years of his death, Semmelweis' doctrine began to be accepted by the wider medical community. In 1874, Billroth demonstrated streptococci in pus from wound infections, and in 1879 Louis Pasteur identified the haemolytic streptococcus in the blood of a woman with puerperal sepsis.3 Joseph Lister, learning of Pasteur's work and germ theory, began to apply antiseptic principles to the practice of surgery, with a dramatic fall in postoperative deaths from infection. As with Semmelweis', Lister's ideas were also greeted with scepticism and it took nearly 30 years for "Listerism" to be universally accepted by medical practitioners.13 By the end of the 19th century, the need for obstetric asepsis was well appreciated. An authoritative text of 1905 gives detailed instructions for the personal hygiene of physicians and nurses attending confinements and instructions on the performance of internal examinations. The importance of "inculcating in the student the principles of obstetrical cleanliness, mechanical and chemical" is emphasised. The need for meticulous antiseptic care during operative vaginal deliveries and manipulations — more frequent then than now — is reiterated.14 Australian medical practitioners were apparently quick to follow the lead of their overseas colleagues in the application of hygienic measures in obstetrics, and of self-regulation when puerperal fever occurred in their practices. Most stopped attending midwifery cases for a time after one or two deaths among their patients.15 Surprisingly though, despite the new understanding of the importance of antisepsis, puerperal sepsis still occurred frequently in developed countries in which figures were kept. It appears the principles of antisepsis were not universally applied. In England and Wales, in the period 1870 to 1890, the maternal death rate in hospital births was around 1 : 20, of which about 40% were due to infection. In the United States, in the 1890s, 20 000 women a year died in childbirth.14,16,17 In New South Wales, in 1894–1896, among confinements of married women, both at home and in hospital, the government statistician found a death rate of 1 : 148, and he commented on the negligence of medical men in filling the certificates required by law. Up to that point, causes of death had been supposedly accurately recorded for more than 40 years, but, in fact, the puerperal nature of fatal infections in women was frequently omitted.14,15 Globally, the most common and most feared infecting organism at the time was the Group A haemolytic streptococcus, whose virulence appears to have diminished in recent years, possibly due to improved socioeconomic conditions and the use of antibiotics. Normally found on the skin, in the nose and throat, and in the vagina, as well as in skin lesions, the streptococcus was introduced into the genital tract during examinations and deliveries. Lacerations, blood loss and exhaustion from prolonged labour increased the possibility of postpartum infection. Staphylococci, gonococci, coliforms and other bowel flora, as well as anaerobes, were less likely culprits, but have assumed greater importance in recent years, as have Group B streptococci.3,7,15 Debating deliveriesIn Australia overall, as elsewhere overseas, the maternal mortality rate (MMR) actually remained steady from 1900 until the late 1930s (5.95 per 1000 women delivered in 1903; 5.13 in 1933). Among developed nations, the United States had the highest MMR and the Netherlands and Scandinavia the lowest, although there were some individual hospitals with remarkably low rates, including the Rotunda in Dublin, Ireland, and Crown Street Women's Hospital in Sydney, Australia.15,17 Causes of the continuing fatal role of puerperal sepsis were widely debated. The medical profession tended to blame untrained midwives, and moved towards their training and registration, which was achieved by the 1930s. Some attributed the rates of sepsis to high levels of interference in labour and delivery, especially forceps deliveries. In Australia, the "lodge" system of practice — whereby families purchased medical services through lodge or friendly society membership — was held to blame. Busy general practitioners contracted under this system were allegedly likely to try to conduct confinements hurriedly.15-17 There were moves both to increase instruction in obstetrics for general practitioners and to encourage specialist obstetricians to do deliveries.15 Antibiotic arsenalAfter 1935, the situation improved rapidly in developed countries. Early that year "a startling therapeutic success" was announced by Domagk in Germany — the prevention of septicaemia in mice experimentally infected with streptococci after the administration of prontosil, a sulfonamide dye.18 In June 1936, Colebrook and Kenny, in a landmark paper, reported their success in treating established puerperal sepsis in women using prontosil — the death rate in apparently similar cases dropped from around 27% to 8%. Colebrook and Kenny wrote (cautiously): ". . . the very low death rate, taken together with the spectacular remission of fever and symptoms observed in so many of the cases, does suggest that the drug has exerted a beneficial effect".18 History was to prove them correct, and in 1939 Domagk was awarded the Nobel Prize in Medicine and Physiology for his work. Prontosil and other sulfonamides were followed by penicillin, to which streptococci causing puerperal sepsis still remain sensitive, and the arsenal of antibiotics used for all other forms of postpartum fever today.3,19 Today, in Australia, deaths from puerperal sepsis are extraordinarily rare (the MMR is currently about 0.1 per 1000 births).2 However, infection and fever are not rare, and the microbes causing them are omnipresent. In caring for pregnant women, especially the many who have some intervention in labour or delivery, we would be wise to reflect that it is only the use of increasingly complex antibiotic regimens which prevents a return to "the terror of the lying-in hospitals".

Caroline M De Costa FRANZCOG, FRCOG

Indigenous health True stories 9 December 2002 Free

Saving Grace: a Christmas story

Christmas Eve, a couple of years ago. I was on call for the birth suite until 8 am the next, Christmas, morning but was hoping to be able to stay at home with my family. At 6 pm, I did a festive round with the registrar on duty. Good — only three women in the suite, and two delivered, both delighted with themselves for getting it over before Christmas Day. In the corner room, one woman in early labour — Grace, aged 34. Elderly for a first baby, especially for an Aboriginal woman, the registrar observes. I say hello to Grace, but don't examine her — that's why the midwives and junior staff are here. Surprisingly, no partner or family is with her. Then I realise that I have seen Grace about our town. She is one of the "park people". Virtually homeless, living mostly outdoors, drifting back and forth between town and some of the more remote communities of the region, the park people are frequently subjected to the ire of some of the town's better-heeled residents. Recently, these residents have demanded more stringent "move-on" laws, to keep the park people out of the sight of the tourists and restaurant patrons along the town's seashore. So far, the State's Anti-Discrimination Commissioner has successfully opposed such laws, but for the park people — rather like those people back in Bethlehem whose birth experience we are celebrating tonight — it seems there is no room at the inn. In her time, like other park people, Grace has had many visits to the hospital's emergency department. At every admission, the same comments appeared: "poor historian"; "C2H5OH"; "lacerations"; "bruises". She'd been sutured many times, with the new and old stab wounds noted. A large scar on her throat and another on her left breast were recorded. Unfortunately, no-one noted the scar on her lower abdomen. Longitudinal and midline. A laparotomy scar. Grace hasn't attended any formal antenatal clinics, but thankfully, during one of her visits to casualty a while back, someone did do an ultrasound scan, so we know she is labouring close to term. Routine antenatal blood tests are being done now. She is in established labour, progressing, and all appears well. I leave it to the registrar to check the results, wish everyone a Merry Christmas, and go home. Two hours later, I am rung by an agitated registrar and, on the strength of what I am told, go back to the birth suite. In conversation with one of the midwives on duty, an elderly Aboriginal woman, visiting another patient, remarked of Grace: "Long time since that girl had a baby!". "Oh no," replied the midwife, "this is her first". "No," the woman was firm. "Had the baby when she was 13. A caesarean. At . . . " — and she named a former mission station some hundreds of kilometres away. The midwife hastened to question Grace. Did she ever have a baby before? It was difficult for her to answer; she is indeed a poor historian. For a start, she has no teeth. Those that weren't knocked out in fights have rotted away. Also, chronic middle ear disease since childhood has made her rather deaf. But she does know that, yes, she did have a baby. A girl. Nobody in the hospital had ever asked her before; she didn't know it was important. Did she have a caesarean? Grace is unsure. It was a long time ago. Did the baby come out through that scar on her tummy? Yes, maybe. It was a long time ago. Where is her daughter now? Grace does not know. Obstetric dilemma: is the abdominal scar longitudinal because Grace had a classical caesar, in which case, because of the risk of uterine rupture, caesarean section should be repeated forthwith? Or — and more likely — was the longitudinal incision merely the route to a standard lower-segment operation, allowing Grace the possibility of a successful vaginal birth this time? For the moment, all seems well. Grace is contracting regularly, has accepted pethidine, and is making progress in labour. She now lies in a clean hospital bed, surprised to be — for perhaps the first time in her life — the centre of concerned attention. We try ringing the hospital near the former mission for more information. It's 9.30 pm on Christmas Eve! We're told: "You want records from more than 20 years ago? You must be joking! Ring back next week." An hour later, a further complication arises. Grace's blood has shown unusual antibodies and it will take some hours to find and crossmatch blood if we need it. We decide to ask for the crossmatch and hope that she delivers vaginally soon and that she won't need surgery or blood. Regularly, anxiously, we watch Grace's vital signs and the fetal monitor. Another two hours later, we have blood, Grace's cervix is 8 cm dilated and the fetal heartbeat has been fine. And then, she begins to bleed. Torrentially. Everyone swings into action. After all, this is what we do best. Acute care. Three wise men appear — anaesthetist, paediatrician and theatre porter — bringing not frankincense, myrrh and a manger but ropivacaine, oxygen and a trolley. In five minutes, Grace is on the operating table; another five, and a spinal block is in place. Soon, a rapid repeat caesarean section is under way. The old scar — in fact, a classical — has ruptured and is bleeding profusely, but it's repairable and the baby is alive. On the stroke of midnight, a baby boy arrives. He is small and scrawny, covered in meconium. But when he gives a feeble cry, Grace smiles and reaches out one arm for him (a blood transfusion is running into the other) and she names him, appropriately, Joseph Christopher. Joseph spends that night and the next in the special care unit. He starts to breastfeed. Grace is eating three meals a day, including turkey and plum pudding. But it's Christmas time, the hospital is short of staff and many beds are closed, so even at this inn Grace cannot stay too long. On Day 5 post-op, Grace and Joseph are discharged "home". As Grace has no home, a place is found for her in a hostel, with domiciliary visits planned. On the first visit, the domiciliary midwife finds things are OK; the next day, Grace and her baby have gone. A few days later — in fact, on New Year's Day — Grace presents to the emergency department again, this time with Joseph. He isn't feeding well and is bringing up feeds; and, he has a fever. But we can deal with all that. It's another acute problem, not one of those complicated social issues that, in hospital practice, just have to be put into the "too-hard" basket. The paediatric registrar arrives, Joseph is admitted and a drip is put up. And so the cycle of disadvantage starts all over again — unto a new generation.

Caroline M De Costa FRANZCOG, FRCOG

Indigenous health Editorials 18 November 2002 Free

Can we better meet the healthcare needs of Aboriginal and Torres Strait Islander women?

When asked about features of women's health services that would best meet their needs, specific groups of Aboriginal and Torres Strait Islander women, despite their diversity, have given very similar responses.1-3 They want women's healthcare that takes a holistic rather than a narrow "single-disease" or biomedical approach; services that are accessible, flexible and supportive; and providers they can trust, who are respectful and who can communicate well. For many Aboriginal and Torres Strait Islander women, having access to a female provider is critical to their acceptance of women's healthcare services. The higher cervical cancer incidence and mortality for Aboriginal and Torres Strait Islander women compared with other women, and the available evidence about screening effectiveness, provide a strong imperative for healthcare providers and funders to listen carefully and respond to what women say they want.4 The article by Coory and colleagues in this issue of the Journal (page 544) quantifies and compares women's participation in cervical screening by analysing data from the Queensland Health Pap Smear Registry.5 Participation for women living in rural and remote Aboriginal and Torres Strait Islander communities in Queensland was generally lower than for women living in other areas. Proportions of women in these communities who had had a Pap smear over a two-year period ranged from 19% to 63%. These results suggest women's needs for women's health services are being better met in some communities than others. In interpreting their analysis, Coory et al used residence in a community where most people were Aboriginal and/or Torres Strait Islander as a proxy for Indigenous status. We believe this is a resourceful and reasonably valid way around Indigenous status not being identified on the Pap smear register. However, one limitation is that we can learn nothing about Aboriginal and Torres Strait Islander women living in other localities (ie, the majority of Aboriginal and Torres Strait Islander women in both Queensland and Australia more generally). It is important that the needs of these women are not neglected because of the lack of quantitative data with which to measure them. We commend the researchers for acknowledging the sensitivities of identifying data from individual Aboriginal and Torres Strait Islander communities in their research. However, rather than only obtaining permission to do so from a government department, we believe consulting directly with members of the communities concerned at an early stage of the project may have been beneficial. Although such a practice is uncommon in this type of research, and may be challenging and more time-consuming, it may also create or strengthen trust, links and understanding, which could be useful when implementing and evaluating subsequent interventions. Coory et al suggest that the higher cervical screening participation rates in some communities are an indication of what is achievable, and express support for a strategy of strengthening primary health care. We agree with these conclusions, but disagree that an intervention study where communities are randomised would be an ideal next step. Although randomised-community intervention trials have been implemented in other settings,6 for Aboriginal and Torres Strait Islander communities the barriers to delivery of women's health services are likely to be highly location-specific and the means to overcome them not amenable to random allocation. We believe any available resources would be better spent on (i) exploring in more detail the factors contributing to high and low levels of participation, and (ii) responding actively to identified issues in communities with lower levels of participation. Barriers to Aboriginal and Torres Strait Islander women accessing women's cancer screening services, and ways of responding to them, have been reviewed — most recently in the context of considering how to support the roles of general practitioners.1,4 We would like to highlight the need to also support the roles of Aboriginal Health Workers (AHWs). Because of their key role in providing primary health care for Aboriginal and Torres Strait Islander people, the need for improved clarity, recognition and support of AHW roles has been identified as a national priority.7 We have worked with many female AHWs who have had personal experience of the impact of cervical cancer on Aboriginal and Torres Strait Islander women and their communities, and are keen to be involved in women's health education and promotion activities. Some AHWs also want to provide women's clinical care, including taking Pap smears. Some of the specific areas needing attention are the provision of better training for AHWs in women's health, and issues of accreditation, legal cover and quality assurance for those wanting to take Pap smears. Finally, we urge caution about evaluating cervical screening programs solely on the basis of participation rates. Recent commentaries have begun to question a primary aim for screening programs of maximising participation, arguing that this may lead to the positive effects of screening being overstated, and the limitations and possible negative effects of screening and its sequelae being ignored or downplayed.8,9 These commentators acknowledge that providing more balanced information about screening may have a negative impact on participation rates, but stress the importance of individuals being informed about screening and being able to choose for themselves whether or not to participate.8 Qualitative research conducted with women in one rural Aboriginal community with high rates of participation in cervical screening found that many of the women had little understanding of cervical screening or its implications.10 For programs successful in terms of participation, questions may remain about the extent to which women are making an informed choice about screening. In many localities, providers' attempts to consistently give adequate information to Aboriginal and Torres Strait Islander women can be constrained by many factors, including lack of time, and language and cultural differences. These barriers, combined with a high level of concern about cervical cancer and evaluation criteria based mainly on participation rates, may lead to an emphasis on persuading women to have a Pap smear rather than on providing information and an opportunity for informed choice. We strongly advocate that evaluators of cervical screening programs take into account not only participation rates, but also Aboriginal and Torres Strait Islander women's views about available health services and their understanding of screening-related issues.

Jennifer M Hunt MB BS MPH FAFPHM Public Health · Lynore K Geia BN, RM, MPH

Indigenous health Research 18 November 2002 Free

Participation in cervical cancer screening by women in rural and remote Aboriginal and Torres Strait Islander communities in Queensland

Objective: To investigate the extent of participation in cervical cancer screening among women who live in discrete rural and remote Indigenous communities in Queensland.Design: Descriptive analysis of data from the Queensland Health Pap Smear Registry for the period March 1999 to February 2001.Subjects: Women aged 20–69 years who had given their address of usual residence as one of 13 discrete rural and remote Indigenous communities in Queensland.Main outcome measures: Proportion of women who participated in cervical screening over a two-year period ("biennial participation percentage") and variation in participation across the 13 communities.Results: Overall, the biennial participation percentage in the Indigenous communities was 41.1%. This was 30% lower (risk ratio, 0.70; 95% CI, 0.67–0.72) than that for the rest of Queensland. There was statistically significant variation among communities, with biennial participation percentage ranging from 19.9% to 63.5%.Conclusions: The variation in participation across the communities suggests that the problem of low participation among Indigenous women is not intractable. Achieving participation rates similar to the highest rates found in our study would be of major benefit to Indigenous women.

Michael D Coory MB BS, PhD · Jennifer M Muller MEnvCommHealth, GradDipHealthProm · Nathan A M Dunn BSc(Hons) · Patricia S Fagan MB BS, FAFPHM

Women's health Editorials 4 November 2002 Free

National guidelines for antenatal testing

It’s time to adopt a cost-effective approach Hypertensive disorders in pregnancy, and particularly pre-eclampsia, remain major causes of maternal and perinatal mortality,1,2 accounting for 15% of maternal deaths and 4% of perinatal deaths. Therefore, a key aim of modern antenatal care is the timely detection and management of pre-eclampsia.1,2 A traditional belief is that this is best achieved by regular, and increasingly frequent, antenatal visits, allowing for both blood pressure measurement and dipstick urinalysis to detect new-onset proteinuria. This strategy underpins the schedule of antenatal care that is still most commonly followed in Australia; namely, monthly visits until 28 weeks of pregnancy, fortnightly visits until 36 weeks and weekly visits thereafter.3 However, it has been apparent for some time that the frequency of visits could be safely reduced without adversely affecting outcomes,4 a notion now confirmed by randomised controlled trials both in the developed and developing world.5 Similarly, it has long been recognised that dipstick urinalysis performs poorly in the detection of proteinuria,1 requiring confirmation by either a formal 24-hour urine collection or a spot urine protein/creatinine ratio.2 However, the accuracy of a dipstick reading is significantly improved if it is read with an automated device rather than visually,6 offering the possibility that routine automated testing for proteinuria may have a place in the detection of pre-eclampsia. In this issue of the Journal, the study by Murray and her colleagues (page 477) explores this possibility.7 The authors prospectively evaluated automated dipstick urinalysis in the diagnosis of pre-eclampsia in almost 1000 unselected women. In a quarter of the women who developed pre-eclampsia proteinuria arose before hypertension. From this, the authors concluded that if the initial screening urinalysis is negative then routine urinalysis thereafter is unnecessary in women with no high-risk factors for pre-eclampsia. These findings and conclusions should encourage providers of antenatal care to reflect on their own practice and to consider whether routine urinalysis is justified, thereby facilitating the provision of the most cost-effective care. The report by Murray et al should also stimulate us to reflect on the cost-effectiveness of the other tests routinely undertaken during antenatal care. It is of concern that there is considerable variation in routine antenatal testing in our hospitals, and that practice is often at odds with available evidence.8 These inconsistencies are not only indicative of inequalities in care, but also suggest wastage of precious and limited resources. Standardisation of antenatal care across Australia, through the development of clinical practice guidelines, might reasonably be expected to reduce this wastage. In the United Kingdom, the National Institute of Clinical Excellence has commissioned the development of such guidelines with 43 recognised stakeholders and a projected completion date by September 2003 (www.nice.org.uk). In Australia, through a project funded by the Victorian Department of Human Services, the three largest public hospital providers of maternity services in Victoria have already developed consensus guidelines on antenatal care. These encompass the delivery of antenatal care, including guidelines for most of the routine tests undertaken in pregnancy.8 These guidelines provide an evidence-based foundation for the rational delivery of antenatal care in these three hospitals. However, they offer far more. The guidelines could be used as a catalyst for the development of national guidelines for antenatal care. An important component of any such development, and one missing from the Three Centres Consensus Guidelines, must be a thorough cost-effectiveness analysis of the various tests and interventions recommended. A cost-effectiveness analysis is important because much of the evidence for the various antenatal testing is imported from overseas and may not be readily applicable to Australia. For example, a recent cost appraisal of screening methods for Down's syndrome in the United Kingdom costed a first-trimester ultrasound examination at about £4 ($12),9 a fraction of the Medicare cost in Australia ($60–$70). In addition, the prevalence of the various infections, such as syphilis and HIV, varies in different regions of Australia, and consequently the currently recommended strategies for screening may need to be modified on a regional basis.10 Such analyses are critical components of the further development of evidence guidelines, but, frustratingly, there has been little support at a national level for the funding necessary for their development and implementation. This is despite an estimate that between $75 million and $100 million is spent annually on antenatal screening in Australia.11

Euan M Wallace · Jeremy J N Oats

Women's health Research 4 November 2002 Free

The clinical utility of routine urinalysis in pregnancy: a prospective study

Objectives: To determine whether routine urinalysis in the antenatal period facilitates diagnosis of pre-eclampsia. Can routine urinalysis during pregnancy be discontinued in women with normal results of dipstick urinalysis and microscopy at the first antenatal visit?Design: Prospective observational study.Setting: A metropolitan public hospital and a private hospital in Sydney (NSW).Participants: One thousand women were enrolled at their first antenatal visit (March to November 1999), and 913 completed the study.Outcome measures: The primary outcome was a diagnosis of de novo hypertension (gestational hypertension, pre-eclampsia, or pre-eclampsia superimposed on chronic hypertension).Results: Thirty-five women had dipstick proteinuria at their first antenatal visit. In 25 (71%) of these women, further dipstick proteinuria was detected during pregnancy, and two (6%) were diagnosed with pre-eclampsia. Of the 867 without dipstick proteinuria at the first visit, 338 (39%) had dipstick proteinuria (> 1+) at some time during pregnancy. There were no statistically significant differences in the proportion of women with and without dipstick proteinuria at their first visit who developed hypertension during pregnancy. Only six women developed proteinuria before the onset of hypertension. Women who had an abnormal result of a midstream urine test at their first visit, compared with women with a normal result, were more likely to have a urinary tract infection diagnosed during pregnancy; however, the numbers were small.Conclusion: In the absence of hypertension, routine urinalysis during pregnancy is a poor predictor of pre-eclampsia. Therefore, after an initial screening urinalysis, routine urinalysis could be eliminated from antenatal care without adverse outcomes for women.

Noreen Murray RM, BN · Caroline S E Homer RM, PhD · Gregory K Davis MD, FRACOG · Julie Curtis RN, RM · George Mangos MD, FRACP · Mark A Brown MD, FRACP

Endocrinology Research 4 November 2002 Free

Gestational diabetes in Victoria in 1996: incidence, risk factors and outcomes

Objectives: To describe the epidemiology of gestational diabetes mellitus (GDM) in Victoria.Study design: Population study of all women having singleton births in Victoria in 1996.Methods: Probabilistic record linkage of routinely collected data and capture–recapture techniques to provide an estimate of the incidence of GDM.Main outcome measures: Risk factors for and the adverse outcomes associated with GDM compared with the non-diabetic population by univariate and multivariate analysis.Results: The estimated incidence of GDM was 3.6% (95% confidence interval [CI], 3.60%–3.64%). GDM is associated with women who are older, Aboriginal, non-Australian born, or who give birth in a larger hospital. The adverse outcomes associated with GDM pregnancies were hypertension/pre-eclampsia (adjusted odds ratio [OR], 1.6; 95% CI, 1.4–1.9), hyaline membrane disease (1.6; 1.2–2.2), neonatal jaundice (1.4; 1.2–1.7) and macrosomia (2.0; 1.8–2.3). Interventions during childbirth were also associated with GDM — for example, induction of labour (3.0; 2.7–3.4) and caesarean section (1.7; 1.6–1.9).Conclusion: Women with GDM had increased rates of hypertension, pre-eclampsia, induced labour, and interventional delivery. Their offspring had a higher risk of macrosomia, neonatal jaundice and hyaline membrane disease.

Christine A Stone GradDipEpidBiostat, MPH, MHSc(PHP) · Kylie A McLachlan MB BS, FRACP · Jane L Halliday PhD · Peter Wein MB BS, FRANZCOG, GradDipEpidBiostat · Christine Tippett MB BS, FRANZCOG, MRCOG

Women's health Letters 4 November 2002 Free

Is breastfeeding best practice?

To the Editor: Thank you to McVeagh1 for highlighting some more of the amazing scientific evidence regarding the benefits of breastfeeding. It is extremely important to continue to emphasise the benefits to mother and child in order to strengthen the individual's resolve and the community's support for breastfeeding. However, my concern is whether the question "Is breastfeeding best practice?" should ever be posed in the first place. Do our natural physiological processes now need to be supported by an evidence base and scrutinised in terms of whether they conform to notions of "best practice"? And should the question about choice between breastfeeding and artificial feeding continue to be asked? McVeagh also posed the question, "Is there justification in the argument that women are being pushed too hard to breastfeed?". Can there ever be too much encouragement given to women to provide nutrition and nurturing hand-in-hand to their baby? We must keep emphasising that breastfeeding is not only about good nutrition, reduction in childhood obesity and other measurable health outcomes. Surely there must remain some areas in our lives that do not require evidence and scientific support. Breastfeeding is about loving and nurturing a baby. It is about human relationships. When one experiences a newborn latching on to feed, the clearly felt surge of hormones from breast to brain, the physical expression of these hormones as a palpable "let-down" reflex and the incredible sight of milk rushing from the breast on demand, we do not need science to tell us that this is one of life's most amazing and wonderful experiences, nor to confirm what breastfeeding mothers innately know to be best practice.

Sandra L Neate

Women's health Letters 4 November 2002 Free

In reply: Is breastfeeding best practice?

In reply: I thank Neate for her comments and for challenging the need to ask "Is breastfeeding best practice?". I appreciate her sentiment that there is more to infant feeding than nutrition and health. However, while there are mothers who don't find breastfeeding pleasurable or easy and are deciding how long to persist; while there are mothers who opt not to exclusively breastfeed for six months or to wean before a year of age; while mothers' advisors prescribe solids or complementary feeds or weaning for myriad problems without evidence for effectiveness beyond a placebo effect; while some believe that the disadvantages of not breastfeeding only apply to infants in developing countries; while there are commercial interests promoting products that undermine exclusive breastfeeding; while the Australian government has not fully implemented the recommendations of the World Health Organization Code and subsequent resolutions;1 while health professionals are receiving "educational material" implying that a new additive makes commercial infant formula more like human milk; and while the scientifically minded among us just need to satisfy our curiosity, we need to know to what extent it matters if an infant is breastfed at all, breastfed exclusively, or breastfed for longer periods. Thank you for challenging the question. The weight of the evidence is such that the real question is not "Is breastfeeding best practice" but "By how much?".

Patricia McVeagh

Women's health EBM: Trials on trial 21 October 2002 Free

The levonorgestrel intrauterine system: a simple and effective alternative for the management of menorrhagia?

Trial: Hurskainen R, Teperi J, Rissanen P, et al. Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial. Lancet 2001; 357: 273-277. QuestionWhat is the effectiveness of the levonorgestrel-releasing intrauterine system (IUS) compared with hysterectomy for the management of women with menorrhagia? Trial details Design: Randomised controlled trial, double-blind. Setting: Five university hospitals in Finland. Patients: Premenopausal women aged 35–49 years, with menorrhagia and no major gynaecological abnormalities were recruited to the study. Exclusion criteria were submucous fibroids, endometrial polyps, ovarian tumours or masses greater than 5 cm, cervical disease, urinary and bowel symptoms or pain resulting from large fibroids, lack of indication for hysterectomy, history of cancer, menopause, severe depression, metrorrhagia as a main complaint, previous treatment failure with levonorgestrel-releasing intrauterine system (IUS), severe acne, and uterine malformation. Interventions: 119 patients were allocated to the IUS group and 117 were allocated to the hysterectomy (any method) group. Hysteroscopy was performed before randomisation only if clinically indicated. Main outcome measures: Quality-of-life measures (including health-related, measured on a scale of 0–1 with the EuroQuol [EQ-5D] instrument), anxiety measures, resource use, menstrual blood loss, haematological indices. Main results: In the IUS group, 24 women (20%) had had a hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation (5 cancelled before surgery and 5 withdrew from the study group). Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change in EQ-5D, 0.10 [95% CI, 0.06–0.14] in both groups), as did other indices of psychological wellbeing. There were no significant differences between the treatment groups except that the hysterectomy group had less pain than the IUS group at 12 months. Overall costs were about three times higher for the hysterectomy group than for the IUS group. Conclusion: The significant improvement in health-related quality of life highlights the importance of treating menorrhagia. During the first year the levonorgestrel-releasing IUS was a cost-effective alternative to hysterectomy for treating this disorder. CommentaryRationale for the trialInternational hysterectomy rates vary considerably; by the age of 60 years, a third of women in the United States will have undergone a hysterectomy and menorrhagia is one of the most common indications.1 Satisfaction rates with hysterectomy have been consistently reported as 95% or higher.2 Quality-of-life measures have also been reported to improve following hysterectomy.3 It is perceived as a permanent solution to the problem of menorrhagia. However, short-term complications following hysterectomy are not uncommon; recent studies report rates of moderately severe complications of 16% while in hospital.4 The IUS is an intrauterine system that can be sited during a clinic visit and its duration of action is five years. The IUS contains 52 mg of levonorgestrel which is released through a rate-limiting membrane (20 μg/24 h), resulting in endometrial shrinkage and a reduction in menstrual bleeding. As the IUS has been proposed as an alternative to hysterectomy, it was important to establish if improvements in quality of life are reported with the IUS. Trial methodsThe trial was well conducted and reported according to published guidelines.5 Patients were allocated to the two treatment groups without the prior knowledge of the investigators, although blinding of patients and investigators was not possible in the follow-up period. An instrument measuring disease-specific QOL may have made QOL differences between the two groups more apparent; however, no disease-specific QOL measure exists. The completeness of follow-up was 97% (228/236), and an intention-to-treat analysis was done. In the IUS group, a third of devices were removed and 20% of the women underwent hysterectomy during the first year of follow-up. Reasons for removal included spotting and other bleeding disorders. This removal rate is higher than the two smaller trials comparing IUS with endometrial resection, which report a 20% removal rate, possibly reflecting the severity of symptoms among women who seek hysterectomy instead of endometrial resection.6,7 The use of health-related quality of life (EuroQol) and other measures of psychological wellbeing was appropriate, and the measures had been validated in the population before the study. Not all women referred for menorrhagia were included. Most of those not participating either did not want to take part or did not meet the eligibility criteria for either of the two treatments. Therefore, it is likely that the study group was representative of women who were candidates for both treatments, and the results can be generalised to the population of women with menorrhagia. The planned five-year follow-up will be welcome. New informationTwo small trials had previously reported that the IUS was an alternative to hysterectomy.8 However, this large randomised trial has improved on those studies, as it included a wider range of outcomes, and shows that, after a year, no statistically significant differences were present between the treatment groups in terms of health status, health-related quality of life, and psychological wellbeing. Cost-effectiveness data favour the IUS. Implications for clinical practiceThis study has shown that, in women with menorrhagia, there were no statistically significant differences between IUS and hysterectomy for the outcomes of quality of life and psychological wellbeing. The quality-of-life data show that the IUS scored as well at 12 months as hysterectomy in seven of the eight areas assessed, with the only difference between the groups being pain scores, despite a 66% reduction in the IUS group. The IUS is by no means the final answer to the problem of menorrhagia — a third of women had the device removed by one year because of bleeding problems. Costs to both the healthcare system and the patient were reduced with the use of the IUS, although these cost differences may reduce with time. The costs of hysterectomy may be higher because of the 30% complication rate reported in this study — similar rates have been reported by others.4,9 This study provides convincing evidence that the IUS is an effective alternative for women with uncomplicated menorrhagia, and should be offered as a treatment choice.

Cynthia M Farquhar MD, FRANZCOG, CREI

Women's health Obituaries 21 October 2002 Free

Joseph Correy AM MB BS FRCOG FAGO FRACS FRACOG

Joe Correy, an outstanding contributor to the field of obstetrics and gynaecology in Tasmania, died on 18 April 2002 of severe Parkinson's disease. Joe was born in Manilla, New South Wales, on 17 June 1925, and moved to Sydney in 1930. Although his family was not well off, he won scholarships that enabled him to study medicine at the University of Sydney, from which he graduated in 1947. After completing his residency at Sydney Hospital, he began training in obstetrics at the Royal Hobart Hospital. He married Lucy Denne in 1950 and went to Oxford, UK, in 1951. He obtained his Membership of the Royal College of Obstetricians and Gynaecologists in 1952 and returned home in the following year. With his great personality, energy and ability, Joe built up a very successful private practice in Hobart over the next 15 years. In 1966, he received a William Morton Lemon scholarship to study ovulation induction in Melbourne, and returned to establish the Gynaecological Endocrinology and Infertility Clinics in Hobart and Launceston later that year. In 1969, accepting an appointment as Director of Obstetrics and Gynaecology at the University of Tasmania's medical school, Joe began a remarkable transition from private practitioner to full-time academic, involving research work, training to run a university department, study and teaching. By 1977 he had been promoted to the position of Professor, which he held until his retirement in 1990. With boundless energy and enthusiasm, he continued to take on new challenges throughout his academic career. In 1972, under a Brown Craig Travelling Fellowship, he studied ultrasound in the United Kingdom and returned to set up and run the first ultrasound service for pregnant women in Tasmania. In 1973–1974, he trained to acquire proficiency in pelvic cancer treatment. In 1981, he organised the IVF Clinic in Hobart, which he ran successfully for many years. He also initiated the collection of statistics for all public and private obstetric procedures in Tasmania. Joe was an active member of many medical committees, including (at various times) secretary and president of the Tasmanian branch of the Australian Medical Association, president of the Royal Australian College of Obstetricians and Gynaecologists, an examiner with the RACOG and the Royal College of Obstetricians and Gynaecologists, and president of the Tasmanian Medical Council and the Australian Medical Council. Joe's enthusiasm for life encompassed car trials, great parties, trips with his travellers' group, bridge and lawn bowls. Integrity, honesty and wit were inherent in his character. He was made a Member of the Order of Australia in 1986 for services to medicine. He also became an Honorary Fellow of the Royal Australasian College of Surgeons in 1975 and received an Advance Australia Award in 1994. Joe is survived by his second wife, Pam, and his three children and their families.

Gerard Gartlan FRANZGOG FRCOG

Women's health Editorials 7 October 2002 Free

Hormone replacement therapy: is it safe for breast cancer patients?

Probably in the short term, but results of ongoing trials are needed to determine longer-term safety Oestrogens play an important role in the development of breast cancer. This is most evident in postmenopausal women: circulating levels of endogenous oestradiol are higher in those who develop breast cancer,1 while use of hormone replacement therapy (HRT) increases breast cancer risk.2 Recent results from the Women's Health Initiative randomised trial showed a 26% excess rate of breast cancer development in women who took combined continuous equine oestrogens and medroxyprogesterone acetate for a mean of 5.2 years compared with placebo.3 This finding is consistent with results of earlier epidemiological studies that suggest breast cancer incidence is increased more by combined preparations than by oestrogen alone.2 Further evidence that oestrogen is important in breast cancer development comes from a study of over 9300 postmenopausal women with early breast cancer.4 This found that anastrozole (an aromatase inhibitor that dramatically reduces oestrogen production) significantly reduced the rate of new contralateral breast cancers compared with tamoxifen (hazard ratio, 0.42; 95% CI, 0.22–0.79; P = 0.005).4 Despite the increased incidence of breast cancer in women who use HRT, most studies have shown either no effect on mortality or a decrease.5 The reason appears to be that breast cancers that develop in HRT users are smaller and clinically less advanced, with a lower rate of node positivity, better differentiation and more favourable histological type, than cancers that develop in women not using HRT.2 Menopausal symptoms are reported by two-thirds of postmenopausal women with breast cancer.6 Can HRT be safely used by these women, or does it have the same impact on breast cancer recurrence as it appears to have on breast cancer development? A number of publications have addressed this issue. One systematic review documented 11 studies involving 214 women who took HRT after a diagnosis of breast cancer, and found that the risk of breast cancer recurrence was lower in HRT users (relative risk [RR], 0.64 (95% CI, 0.36–1.15) than in control women who did not use HRT.5 Durna and colleagues report similar findings in this issue of the Journal (page 347).7 They found significantly lower rates of recurrence (RR, 0.62; 95% CI, 0.43–0.87) and death from breast cancer (RR, 0.40; 95% CI, 0.22–0.72) in women who used HRT compared with non-users.7 These are important data and are also consistent with those of a recently published United States case–control study of 174 women who chose to use HRT after breast cancer diagnosis and matched non-users.8 These three studies reported a consistent reduction in recurrence and death from breast cancer in breast-cancer survivors who used HRT to treat menopausal symptoms, but all had potential confounding factors.5,7,8 All studies to date have been observational and are thus subject to a variety of biases. In the Australian study, women who used HRT after treatment of breast cancer had smaller tumours and fewer involved nodes compared with non-users, and were more likely to have used HRT before diagnosis.7 Although the final model adjusted for a number of prognostic factors, these did not include tumour grade, concurrent use of tamoxifen or oestrogen-receptor status. Concurrent tamoxifen is a particular confounding factor, as it was prescribed for almost 60% of women who used HRT, and would have limited the effects of oestrogen on normal and malignant breast epithelium.9 Duration of HRT use after a diagnosis of breast cancer was short in all three studies — a median of only 1.75 years in the Australian study. Surprisingly, in both the Australian7 and American8 studies there appeared to be a lower rate of breast cancer recurrence in patients taking progestogen alone, vaginal oestrogen alone, or a combination of the two. It is difficult to believe that the small amounts of oestrogen absorbed from vaginal preparations could have a positive influence on breast cancer recurrence and survival. This suggests that other characteristics of women who use HRT, whether vaginal or oral, may influence outcome. Socioeconomic status is an independent predictor of breast cancer recurrence and survival: women with more education and higher socioeconomic class have a lower recurrence rate and better survival.10 Hot flushes are more commonly reported by educated women,6 and these women are more likely to take HRT. Thus, socioeconomic factors could conceivably be part of the reason for the better outcome of women with breast cancer who take HRT. What other possible reasons are there to explain why HRT use by women with breast cancer might improve survival? Most of the oestrogens used in HRT preparations are conjugated, a form that does not occur naturally in humans. They are termed "impeded oestrogens", as they interfere with the effect of more powerful, naturally occurring oestrogens, such as oestradiol, and their biological effect on breast cancer cells is unclear. In the pharmacological doses used, they are likely to have direct anti-oestrogenic effects and may also downregulate the oestrogen receptor. The progestogens used in combined HRT preparations may also have anti-oestrogenic effects and are weak aromatase inhibitors. This may be relevant in postmenopausal women, as much of the oestrogen present within their breast cancers is produced locally from androgens by aromatase.11 How should women with breast cancer who develop menopausal symptoms be treated? For vaginal dryness, water-based lubricating gels and vaginal moisturisers significantly improve symptoms. If these measures fail, then locally delivered oestrogens are effective.12 For systemic symptoms, such as hot flushes, evening primrose oil, soya and black cohosh are rarely effective, but low-dose megestrol acetate and the antidepressants venlafaxine and fluoxetine were shown to have benefits in randomised trials in breast-cancer survivors.12,13 More recently, isoflavones from red clover were shown to reduce hot flush symptoms in postmenopausal women,14 although there have been no studies in breast-cancer survivors. When these remedies fail, then HRT can be given in the knowledge that current data do not show any detriment in terms of recurrence or survival. Effective agents for osteoporosis in women with breast cancer include bisphosphonates, tamoxifen, raloxifene, diet and exercise.12 Ongoing randomised trials of HRT in breast-cancer survivors will determine whether longer-term HRT is safe. These trials will evaluate whether the increased incidence of breast cancer and reduced sensitivity of mammography in women using HRT2 are important issues in women with breast cancer. Even if these trials show HRT to be safe, the problem in future will be how to treat menopausal symptoms in women taking one of the new aromatase inhibitors, which are already replacing tamoxifen in postmenopausal women with hormone-responsive breast cancer.4 It makes no sense to give these women oestrogen. Ongoing studies are investigating the role of a variety of agents, including tibolone (a synthetic corticosteroid with oestrogenic, androgenic and progestational activity).

J Michael Dixon

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