International guidelines, patents and trials
Women’s health—what’s new worldwide
Shona Kirtley, Catriona Murray and Stephen Kennedy, NHS Evidence—women’s health, Nuffield Department of Obstetrics and Gynaecology, University of Oxford. To keep up-to-date with the latest evidence-based women’s health information visit NHS Evidence—women’s health: http://www.library.nhs.uk/womenshealth
Out-of-pocket costs for facility-based maternity care in three African countries
This research paper, published by Family Care International (a nonprofit organisation that aims to make pregnancy and childbirth safer around the world), investigates the out-of-pocket medical expenses of women and their families in Burkina Faso, Kenya and Tanzania. Two population-based surveys were carried out, one in 2003 and the other in 2006. A total of 50 911 women were interviewed to identify their experiences of maternity care and any associated costs incurred during labour.
The principal costs arise from having a skilled birth attendant (SBA) present at the delivery, which usually requires the woman to deliver at a health facility. Having access to an SBA is considered a key factor in reducing maternal and perinatal mortality rates and is one of the measures for assessing progress towards achieving Millennium Development Goal 5 (MDG5). The associated costs must be met and although many countries are trying to reduce the charges that were levied on such services in the 1980s and 1990s, this paper found that facility-based deliveries cost families a substantial proportion of their monthly income. Political commitment is needed to help address the problem. It is therefore encouraging that the cost of out-of-pocket expenses was lower in Kenya in 2006 than in 2003, suggesting that a 2004 government policy to reduce user fees at mid- and low-level facilities is having a positive impact.
In the May 2009, issue of BJOG, we reported a strategy for increasing the presence of SBAs in Nepal—the Safe Delivery Incentive Programme. Although there are multiple reasons (such as inaccessibility, cultural beliefs, etc.) for low SBA levels at delivery that may be difficult to resolve, financial issues can be more manageable. We should learn from the success of various programmes that have been tried around the world.
HIV in Pakistan: preventing a future epidemic in most-at-risk groups
This briefing paper prepared by the Programme for Research and Capacity Building in Sexual and Reproductive Health and HIV in Developing Countries, and based on work conducted by the National AIDS Control Programme in 2007, reviews the prevalence of HIV and STIs in injecting drug users and male, female and transgender sex workers in two provinces in Pakistan. The report argues that although prevalence rates are currently low in these groups, they are projected to rise.
Five recommendations have been proposed to prevent a rise: needle and syringe exchange programmes; comprehensive sexual health care for male and transgender sex workers; sexual and reproductive health care for female sex workers; targeted behaviour change communication for most-at-risk groups; addressing stigma and discrimination, and protecting human rights. Recommendations have also been listed for specific groups such as the Pakistani Government and potential donors/funders. One of the key challenges is how to influence political and public will to address this problem. Injecting drug users and commercial sex workers commonly experience violence, abuse and discrimination; hence, interventions targeted at these groups may have little support from society. To overcome these barriers, the report suggests that interventions could be implemented by NGOs, while recognising that this strategy may lead to problems with sustainability and works against integration.
Managing HPV: Health Care Team Tool Kit
This toolkit forms part of an education programme created by the Planned Parenthood Federation of America Inc., the Association of Reproductive Health Professionals and the American Society for Colposcopy and Cervical Pathology. The toolkit is available as a series of documents including: a treatment algorithm for external genital warts; a curriculum for community educators; a quick reference guide for clinicians on managing HPV; an HPV Powerpoint presentation; a manual for business personnel, and a list of FAQs. The toolkit is aimed at raising awareness and increasing knowledge of HPV screening, vaccination and treatment among clinicians, managers, educators and healthcare providers. The quick reference guide for clinicians is easy to read and provides a good overview of the latest developments and research in the area.
Implementation of the World Bank’s Strategy for Health, Nutrition, and Population (HNP) Results: achievements, challenges, and the way forward
This report provides an overview of the progress achieved over the past 20 months by the World Bank in implementing its 2007 strategy for health, nutrition and population (HNP) results. The Bank’s strategic vision, over a 5-year period, is to put in place systems for supporting poor countries to reduce poverty, strengthen their health systems and improve the available health services. The report highlights the fact that basic health systems in many countries need strengthening, as health-related MDGs cannot be achieved without a solid foundation to meet basic needs. The report examines: renewing the Bank’s focus on HNP results by increased use of results-based financing; strengthening health systems for HNP results; emphasising multi-sector involvement in HNP, and improving harmonisation and strategic engagement with global partners. There is also an interesting discussion on the impact of the current global financial crisis on attaining the strategic vision. A number of recommendations are proposed to ensure the continued implementation of this strategy.
Clinical trial recruitment
Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.
Therapeutic magnetic resonance imaging (MRI)-guided high intensity-focused ultrasound (HIFU) ablation of uterine fibroids
This interventional study aims to determine the safety and technical effectiveness of MRI guided HIFU in ablating uterine fibroids. The ultrasound beam penetrates soft tissue and induces high temperatures (55–70°C) for a few seconds resulting in well-defined regions of protein denaturation, irreversible cell damage and necrosis at the target site. Evaluation of safety, quality of life and imaging endpoints for each patient will be performed.
Inclusion criteria: symptomatic women, 18–59 years old; weight <140 kg; pre- or peri-menopausal; uterine size <24 weeks; dominant fibroid ≥3 cm ≤12 cm; normal cervical smear.
Primary outcome measure: safety and technical efficacy of HIFU of the uterine fibroids.
Secondary outcome measures: qualitative measures of pain, return to activity and Quality of Life Scores.
Trial site: various locations in France, Germany, Korea and the Netherlands.
Anticipated trial end date: December 2009.
High intensity-focused ultrasound is increasingly being offered as a treatment for small lesions such as prostate cancer but there are very few studies relating to uterine fibroids (Fruehauf et al. Arch Gynecol Ostet. 2008; 277: 143–50). It remains to be determined, therefore, whether the treatment is feasible for large fibroids.
Study of the molecular genetics of menstrual migraine
This case–control study aims to investigate the role of genes in menstrual migraine. This will be performed by comparing the genetic profile of 300 women with menstrual migraine against that of 300 women with no personal or family history of the disorder. The effect of hormones on the expression of genes will also be examined in 30 subjects and controls by the analysis of RNA from blood samples taken during the follicular and luteal phases.
Primary outcome measure: analysis of DNA (from saliva samples) to determine if candidate genes, already implicated in migraine, are more common in cases with menstrual migraine than in controls; analysis of RNA to examine if hormonal changes during menstruation affect the expression of the candidate genes.
Secondary outcome measures: analysis of DNA to identify new genes that may be involved in menstrual migraine development; analysis of RNA to examine if hormonal changes during menstruation affect the expression of these genes.
Trial site: London, UK and Australia.
Anticipated trial end date: November 2018.
Our current understanding of the contribution of molecular genetics to the pathophysiology of migraine comes principally from studies of a rare monogenic subtype called familial hemiplegic migraine (deVries et al. Hum Genet 2009, epub in print). It will be interesting, therefore, to see whether the planned study provides any novel insights into menstrual migraine, as a sub-phenotype, given the small sample size and how little is known about the molecular genetics of migrawine in general.
Surgical treatment of pelvic joint instability in patients with severe pelvic girdle pain after pregnancy and trauma
This study aims to determine the effectiveness of surgical treatment (arthrodesis to the sacroiliac joint and pubic symphysis) for pregnancy-related pelvic girdle pain as a result of pelvic joint instability. Surgery will be performed on only one joint at a time. Radiostereometric analysis will be used to evaluate joint movement.
Inclusion criteria: pain in one or more pelvic joints; at least two positive clinical tests; high pain and disability score; adequate physiotherapy tried without effect.
Primary outcome measure: Oswestry Disability Index and Visual Analogue Scale.
Secondary outcome measures: Short form health survey (SF-36); healing measured by CT.
Trial site: Oslo, Norway.
Anticipated trial end date: June 2011.
A previous study on pregnancy-related pelvic girdle pain by Zwienen et al. (Spine 2004; 29: 478–84) has shown some benefit for surgery in postnatal women with pain refractory to all other treatments.
Exercise induced improvement of the venous reserve capacity in formerly pre-eclamptic women
This study aims to determine the effectiveness of physical exercise (in terms of vascular and endothelial functioning) in formerly pre-eclamptic women compared with those who have had an uncomplicated pregnancy. It also aims to investigate vascular adaptation in a subsequent pregnancy in both groups.
Women will be recruited to one of three arms: previous pre-eclampsia with low plasma volume; previous pre-eclampsia with normal plasma volume, and women who have had a normal pregnancy.
Primary outcome measure: increased plasma volume.
Secondary outcome measures: venous compliance; endothelial dysfunction; sympathetic resting activity; splanchnic blood flow.
Trial site: Nijmegen, Netherlands.
Anticipated trial end date: June 2013.
Women with low plasma volume show a reduced ability to adapt their cardiovascular system to a new pregnancy and are more likely to suffer hypertensive disorders. In addition, it is known that exercise increases the plasma volume in healthy adults and it is anticipated, therefore, that the same will apply in those with previous pre-eclampsia so that lifestyle changes may be able to reduce recurrence of the problem in future pregnancies.
Court orders Nepal to improve women’s access to abortion
Abortion has been legal in Nepal under certain circumstances since 2002. However, access has been limited because of problems implementing government policy. In response, the Supreme Court has recently ordered the government to introduce laws to guarantee access to safe and affordable abortion for all women through the provision of funds to (a) cover the cost of abortion services and (b) educate the public and health service providers.
Women, HIV and human rights: the crisis of criminalisation
The Salamander Trust (an organisation that aims to protect, promote and enhance the health and rights of people marginalised by societies as a result of their gender, HIV status or sexual and reproductive health) recently gave a presentation, at the House of Commons in London, during a meeting to discuss women and HIV. The effects on women’s reproductive health rights of global attitudes regarding women with HIV were discussed. The presentation examines legal issues in various countries around the world, particularly the impact of criminalisation on HIV transmission in certain countries, and investigates what strategies the UN and other organisations have adopted to uphold the rights of HIV positive women.