International guidelines, patents and trials
Women’s health—what’s new worldwide
Shona Kirtley, Bryn Kemp 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
Agenda for accelerated country action for women, girls, gender equality and HIV: operational plan for the UNAIDS action framework addressing women, girls, gender equality and HIV
This Joint United Nations Programme on HIV/AIDS (UNAIDS) action framework was developed through a comprehensive consultation process conducted by the UN Global Taskforce on Women, Girls, Gender Equality and HIV. The operational plan recognises that gender inequalities and human rights violations across the globe present barriers to progress made in the prevention of HIV transmission and access to antiretroviral therapy. Recommendations to address factors hindering current policies and programmes focus on three issues identified by the Global Taskforce: knowing, understanding and responding to the particular and various effects of the HIV epidemic on women and girls; translating political commitments into scaled-up action to address the rights and needs of women and girls in the context of HIV; and ensuring an enabling environment for the fulfilment of the human rights of women and girls. In line with the UN Millennium Development Goals, countries are urged to: (a) empower the leadership of women and girls living with HIV and (b) develop policy to ensure access to integrated HIV and sexual and reproductive health services. Action to reduce violence against women and address the needs of marginalised women and girls will improve healthcare within these groups. This agenda is particularly timely given a recent commitment by the UN to establish a new agency specifically for women.
National standards and implementation guide for youth-friendly health services
The Ministry of Health in Bhutan has developed national standards to ensure that high-quality and accessible services are provided to all young people in the country. Sixty percent of the Bhutanese population is below the age of 25 and so it is vital to ensure that young people have access to comprehensive sexual and reproductive, as well as general, health services. The strategy involves a reorganisation of the existing health system in Bhutan. This document clearly sets out the desired standards and provides implementation guidelines for providers to develop and establish the required health services at community, primary and secondary care levels. The introduction to these national standards includes a fascinating discussion about current attitudes and practices in Bhutan relating to adolescent sexuality and sexual behaviour, marriage, pregnancy, HIV, contraception and nutrition. It also provides an overview of health policies and existing laws that impact on young people in Bhutan.
Barriers and gaps affecting mHealth in low and middle income countries: policy white paper
Mobile health, or mHealth, refers to the health-related use of mobile telecommunication and multimedia technologies to deliver health care. The unexpected uptake of mobile phone technologies within low and middle income countries (LMICS) has resulted in a surge in the provision of information services aimed at improving health care. People in remote areas, where internet access and electricity supplies can be poor, are benefiting from better access to direct public health messages, faster diagnosis and disease tracking, and development of continuing education for healthcare workers. Early indicators suggest that mHealth has begun to transform health care in various LMICS. However, the sustainability of the approach is unclear given the predominance of small pilot projects, with fragmented services that threaten the realisation of mHealth’s potential. This white paper from the Center for Global Health and Economic Development at the Earth Institute Columbia University (New York, NY, USA) and the mHealth Alliance outlines the current barriers and challenges affecting mHealth initiatives in LMICs. The authors assess the existing mHealth evidence base, and identify key gaps in knowledge affecting the scale and sustainability of mHealth initiatives. The report recommends that collaboration between public and private bodies is vital in ensuring that investment can be used to develop targeted, appropriate, integrated and viable mHealth services in LMICs.
This comprehensive and easy to use toolkit, available from K4Health, a project implemented by The Johns Hopkins Bloomberg School of Public Health’s Center for Communication Programs (CCP), is a one-stop resource for programme managers, service providers and policy-makers, on long-acting, hormonal, contraceptive implants. Developed by the Long-Acting and Permanent Methods (LA/PMs) Community of Practice, EngenderHealth, Family Health International, Johns Hopkins’ Centre for Communication Programs and the US Agency for International Development, the Implants Toolkit provides information relating to: policies and guidelines; training; logistics; programme management; service delivery; country experiences; and electronic resources. The programme management section includes information on models and approaches, cost considerations, supervision, monitoring and evaluation for programme managers and family-planning professionals to set-up, organise, manage and evaluate contraceptive implant services.
Clinical trial recruitment
Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.
Autologous ovarian cancer-dendritic cell vaccine in ovarian cancer
This open-label, three-arm, sequential, pilot trial aims to assess the feasibility, safety and immunogenicity of an ovarian cancer dendritic cell vaccine (OCDC) in women with recurrent ovarian, fallopian tube or primary peritoneal cancer. OCDC is an autologous vaccine containing dendritic cells; as specialised antigen-presenting cells, these have been employed in vaccines to treat cancer (see review, Immunity 2008;29:372–83). OCDC will be administered intranodally alone, or in combination with Daclizumab ± Bevacizumab, both human monoclonal antibodies (against the alpha subunit of the interleukin-2 receptor and vascular endothelial growth factor-A, respectively) with measurable anti-tumour activity in women with ovarian cancer (see review, Gynecol Oncol 2010;117:152–8).
Inclusion criteria: recurrent ovarian (including low malignant potential), fallopian tube or primary peritoneal cancer; prior secondary cytoreductive surgery yielding tumour for lysate preparation; current largest tumour nodule ≤4.5 cm by computed tomography or magnetic resonance imaging; ≥18 years old; Eastern Cooperative Oncology Group performance status ≤1; platinum-sensitive (progression-free interval ≥6 months before recent recurrence) or platinum-resistant (progression-free interval <6 months before recent recurrence).
Primary outcome measure: safety by grading the observed toxicities within 30 days of last vaccination using the NCI Common Toxicity Criteria v3.0.
Secondary outcome measures: clinical response; dose limiting toxicity; immune response.
Trial site: Pennsylvania, USA.
Anticipated trial end date: May 2012.
Comparative efficacy and safety of intravenous ferric carboxymaltose versus oral iron for iron deficiency anaemia in pregnant women (ASAP)
This randomised controlled trial aims to compare the efficacy of intravenous ferric carboxymaltose (1000–1500 mg) and oral ferrous sulphate capsules (100 mg twice a day) for the treatment of iron deficiency anaemia during pregnancy.
Inclusion criteria: ≥18 years old; >20 and <33 weeks of gestation at baseline visit with normal antenatal screening test results; haemoglobin (Hb) ≤8 g/dl, or <10.5 g/dl and serum ferritin ≤20 μg/l at screening.
Primary outcome measure: average Hb increase after 3 weeks of treatment.
Secondary outcome measures: Hb changes after 6, 9 and 12 weeks of treatment.
Trial site: Berlin, Germany.
Anticipated trial end date: March 2010.
The effect of a non-hormonal COX-2 inhibitor (Celebrex) on ovulation
This randomised controlled trial aims to determine the effects on ovulation of the selective, non-steroidal, cyclo-oxygenase 2 (COX-2) inhibitor, Celebrex. The pre-ovulatory surge of gonadotrophins triggers a marked increase in follicular prostaglandin (PG) synthesis before ovulation, resulting from the selective induction of COX-2. Non-steroidal anti-inflammatory drugs (NSAIDs) consistently inhibit ovulation in all mammalian species studied so far, almost certainly as a result of the inhibition of COX-2 (see review, Hum Reprod Update 2004;10:373–85). This also means that NSAID therapy could be an important, frequently overlooked, cause of ovulatory dysfunction.
Inclusion criteria: 18–35 years old; not using hormonal contraception; cycle length 26–34 days; good general health; body mass index ≤ 30; serum progesterone > 3 ng/ml (cycle day 18–25).
Primary outcome measure (assessed by hormone levels and ultrasound scanning): blocking ovulation when taken before ovulation; extended luteal phase when taken after ovulation.
Secondary outcome measures: delaying ovulation when taken before ovulation; premature onset of menses when taken after ovulation.
Trial site: Oregon, USA.
Anticipated trial end date: September 2011.
The use of DHEA in women with premature ovarian failure
This open-label, non-randomised trial investigates the use of dehydroepiandrosterone (DHEA) in women with premature ovarian failure who wish to conceive, after a small study reported some spontaneous conceptions on treatment (Fertil Steril 2009;91:644–6). DHEA supplementation has also been associated with improved embryo quality and reduced miscarriage rates in women with diminished ovarian reserve (Curr Opin Obstet Gynecol 2009;21:306–8).
Inclusion criteria: women with premature ovarian failure.
Primary outcome measures: follicle-stimulating hormone, anti-Müllerian hormone, estradiol, ovarian volume, antral follicle count, pregnancy.
Trial site: Virginia, USA.
Anticipated trial end date: May 2013.
EP 2049906 B1 An assay for predicting implantation success in assisted fertilisation. This European granted patent describes an assay which can indicate, before fertilisation, the chances of successful implantation of an oocyte. The inventors specifically propose that a high level of granulocyte colony-stimulating factor (G-CSF) in the follicular fluid from which the oocyte is derived suggests that the oocyte has a potentially higher success rate of implantation when fertilised.
Lédée, N., Piccinni, MP., Lombroso, R. Assay and kit for predicting implantation success in assisted fertilisation. 19 May 2010.
US 7723289 PIF tetrapeptides. This US granted patent relates to the biological effects induced by in vitro and/or in vivo preimplantation factor (PIF) peptides, peptidomimetics (peptide-like structures) and compounds derived from preimplantation embryos, based upon the C-terminal tetrapeptide of PIF peptides. The peptides and peptidomimetics can enhance endometrial receptivity, block activated but not basal immunity, inhibit cell proliferation and create a T helper type 2 cytokine bias within the CD4 lymphocyte population. It is hoped the compounds could be used to modulate immune activity and to develop antibodies to detect PIF peptides in human embryo culture media as an index of embryo viability.
Barnea, E. PIF tetrapeptides. 25 May 2010.
US 2010/0120076 A1 Method for antenatal estimation of risk of aneuploidy. This patent application describes a system for determining the risk of carrying a fetus with chromosomal anomalies. The inventors propose a novel screening test to identify Down syndrome and other anomalies using biomarker concentrations from maternal blood serum. A numerical model is used to assess the interactive properties of two biomarkers for fetal aneuploidy. Rather than individual analytes being compared as multiples of the median, modelling is based on a comparison of concentration ratios. The inventors claim that their method offers improved detection rates and lower false-positive rates when compared with current screening tests using biochemistry alone.
Braun, G., Marcus-Braun, N., Birk O. Method for antenatal estimation of risk of aneuploidy. 13 May 2010.
WO 2010/054068 A2 Cyclic adenosine monophosphates for reducing the formation of adhesions. This world patent application claims the use of various derivatives of cyclic adenosine monophosphates for the reduction of adhesion formation for reducing inflammation or tissue damage after abdominal or pelvic surgery.
Jackson, EK. Cyclic adenosine monophosphates for reducing the formation of adhesions. 14 May 2010.
US 2010/0113340 A1 Nucleic acids coding for adhesion factor of group B streptococcus, adhesion factors of group B streptococcus and further uses thereof. This US patent application claims a nucleic acids molecule coding for a fibrinogen-binding polypeptide, for treating, preventing or diagnosing group B streptococcus infection and for use in the development of a vaccine.
Reinscheid, D., Gutekunst, H., Schubert A., Eikmanns, B., Meinke, A. Nucleic acids coding for adhesion factor of group B streptococcus, adhesion factors of group B streptococcus and further uses thereof. May 6 2010.
Brazil: ‘fetal rights’ bill
A bill, voted through the Family and Social Security Commission of the Brazilian House of Representatives in May 2010, is due to be debated in the national Congress. It proposes the provision of extensive rights for a fertilised egg, giving it priority over the health of the woman. Moreover, any act that could be perceived to have a negative impact on the fertilised egg would be classed as illegal. This proposed change to legislation in Brazil follows a number of other recent legal changes regarding fertilised ova within Latin America.
Mexico: Supreme Court protects rape victims
On 27 May 2010, the Mexican Supreme Court granted access to emergency contraception and abortion for all rape victims. The decision is the result of a challenge brought by the state of Jalisco to a federal health directive issued in February 2009 requiring health professionals to offer emergency contraception and termination to rape victims in Mexico.