International guidelines, patents and trials
Women’s health—what’s new worldwide
Shona Kirtley, Women’s Health Researcher. John Thorp, North Carolina Center for Women’s Health Research, USA.
An update on WHO’s work on female genital mutilation
This progress report from the World Health Organization (WHO) provides an overview of the prevalence, human rights implications, health risks, persistence and the increasing medicalisation of female genital mutilation (FGM) and presents the findings of the latest WHO FGM studies from Burkina Faso, Egypt, Gambia, Ghana, Nigeria, Senegal, Sierra Leone and Sudan. The report also comprises a comprehensive account of the work that the WHO has been participating in to reduce the practice of FGM. The report states that every year around 3 million girls around the world are at risk of being subjected to this traditional practice and that FGM is still practised in 28 African countries and some countries in Asia and the Middle East. Figures show that in some countries the practice of FGM is declining—however, some studies also indicate that the average age at which girls are subjected to this operation is lowering and that there is an increase in the number of parents seeking this procedure from health professionals. The report calls for programmes aimed at reducing the practise of FGM to be stepped up, particularly around three key action areas: social, legal and political commitment. The action areas identified by the WHO clearly delineate that FGM is a cultural and religious phenomenon that women’s health clinicians can treat the sequelae of, but that only shifts in the social standing of women can reduce this practice and its subsequent harms.
This website, produced by the United States Agency for International Development (USAID) postabortion care working group, provides access to evidence-based information on postabortion care (PAC). The website, known as the PAC Global Resources Guide, contains policies, standards, programme and service delivery guides, research, training curricula, funding information, communication leaflets and tools to encourage community mobilisation. Information is available in English, Spanish, French and Russian. The included resources have all undergone extensive international review and field testing. The PAC resources are aimed at policy makers and programme managers who are involved in designing or revising PAC services. The resources on the website are intended to complement existing PAC materials currently in use in countries around the world. Termination of pregnancy is an elective procedure most often completed surgically in free-standing offices or clinics where women receive same-day procedures. The convenience and availability of same-day termination of pregnancy procedures make the availability of PAC a critical component so that women who experience complications can receive PAC to prevent any long-term harm.
Understanding and improving aboriginal maternal and child health in Canada
The Health Council of Canada has initiated a multi-year research project to assess the disparities faced by aboriginal people in Canada that impact on the health of these communities and to provide recommendations and develop robust programmes to address these challenges. The Health Council of Canada has spent the first year investigating access to and provision of health care to pregnant women and to children from the prenatal stage to age 6 years. Seven regional meetings, covering both urban and rural areas, were held across Canada involving healthcare professionals, academics, government officials and people representing the First Nations, Inuit and Métis communities. The objective was to capture information ‘on the ground’ and to discover what initiatives actually work in the field. Five themes were identified for discussion: traditional knowledge and cultural approaches; community-based and community-focused approaches; collaboration and integration; training and human resources; policy and funding. The report states that although many federal programmes addressing maternal child health are proving to have some impact, the perception among local people is that the government is not committed to implementing a comprehensive, long-term coordinated service delivery programme that allows all aboriginal people to benefit from these programmes and that funding arrangements are so complex that the potential success of programmes is severely constrained. Health disparities for aboriginal people remain a perplexing problem that Western health agencies continue to try to reduce.
Equity, social determinants and public health programmes
This book published by the WHO assesses the evidence, found by the Commission on Social Determinants of Health in 2008, that the drivers of health inequities exist in social, economic and political environments and aims to translate the evidence into tangible, practical and effective solutions to address these health inequalities. Each chapter focuses upon a particular problem such as health and nutrition of children, diabetes, tropical diseases, violence and unintended injury and unintended pregnancy and pregnancy outcome. Detailed figures are provided outlining the prevalence of exclusive breastfeeding in children between birth and 3 months of age in low-income countries, rates of skilled delivery care, the under-5 mortality rate and a list of interventions for which a formal equity impact evaluation has been conducted. The book states that ‘policy-makers, planners and health workers should be aware that the way in which they plan and implement preventive and curative interventions often contributes to further increasing inequities’ and that ‘mainstreaming equity considerations in the health sector is essential for ensuring that those involved become part of the solution, rather than part of the problem’.
Clinical trial recruitment
Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.
3.0 Tesla magnetic resonance imaging for breast cancer detection in high-risk women
This study aims to determine whether the use of 3.0 Tesla (3.0-T) magnetic resonance imaging (MRI) improves the accuracy of diagnosing breast cancer in high-risk women who have a suspicious mammographic lesion (categorised as Breast Imaging Reporting and data System [BI-RADS] 4) and require biopsy. The MRI will be performed before the biopsy.
Inclusion criteria: Women at high risk of developing breast cancer as outlined by the American Cancer Society (that is, women with known predisposing mutations in BRCA1, BRCA2 or PTEN genes), women with a first-degree relative who is a known carrier or has a 20% or more lifetime risk of breast cancer); the above high-risk women with a suspicious lesion classified as BI-RADS 4 that is detected on mammography (because the spatial resolution of 3.0-T breast MRI is similar to digital mammography, there is no limitation to the size of the mammographic lesion).
Primary outcome measure: Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI.
Secondary outcome measures: Percentage of participants with incidental lesions detected by MRI; false-positive rate; false-negative rate.
Trial site: New York, USA.
Anticipated trial end date: August 2013.
Healthcare intervention research—improving prenatal and maternal care (QUALMAT)
This study aims to determine the effectiveness of a computer-assisted decision support system designed to increase healthcare staff motivation and the introduction of an incentive scheme on improving the quality and delivery of prenatal and maternal health services in low-income countries. Given the high uptake of smart phones around the world, it is plausible to believe that programmes such as these could be deliverable to large portions of the population.
Inclusion criteria: The woman a patient in the primary healthcare centre.
Primary outcome measure: Motivation.
Secondary outcome measures: Improved quality of health services in antenatal care and delivery.
Trial site: Heidelberg, Germany.
Anticipated trial end date: April 2014.
Single embryo transfer of a euploid embryo versus double embryo transfer
This randomised controlled trial aims to compare the pregnancy and delivery rates of women receiving fertility treatment who either undergo chromosomal testing before a single embryo transfer or have two untested embryos transferred.
Inclusion criteria: Maximum of one previous failed in vitro fertilisation (IVF) cycle (a failed cycle is any cycle that did not deliver, pregnancy losses are failed cycles, can have participated as a recipient in an egg donor cycle); female partner <43 years old at time of onset of IVF cycle; maximum previous day 3 follicle stimulation hormone (FSH) level of 12 (in Reproductive Medicine Associated of New Jersey laboratory); minimum anti-mullerian hormone of 1.2 within 1 year; normal uterine cavity demonstrated by saline sonogram, hysterosalpingogram or hysteroscopy within 1 year; male partner with >100 000 total motile spermatozoa (donor sperm acceptable); BMI ≤30 kg/m2.
Primary outcome measure: Live birth rate per randomised patient (single embryo transfer versus two embryo transfer).
Secondary outcome measures: Twin live birth rate; sustained implantation rate; live birth rate per embryo transfer.
Trial site: New Jersey and Pennsylvania, USA.
Anticipated trial end date: August 2014.
Phenotyping and genotyping POF (WHO III)
This study aims to obtain (via a questionnaire, ultrasonography and blood samples) detailed phenotypes of women with hypergonadotrophic ovarian dysfunction (WHO III) including women with premature ovarian failure (POF), incipient ovarian failure, poor response after ovarian hyperstimulation, early menopause and hypergonadotrophic primary amenorrhoea who are attending clinic for routine endocrine screening for genotyping. Genotyping will also be performed with the aim of identifying genetic factors associated with the premature depletion of ovarian follicles and in women with familial WHO III genome wide linkage analysis will be performed.
Inclusion criteria: POF (defined as secondary amenorrhea before 40 years of age and basal FSH >40 IU/l); incipient ovarian failure (defined as normo-ovulatory cycles, raised basal FSH >12 IU/l); women with poor response (defined as fewer than four oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotrophins or cancellation in case of absent follicle growth); women with early menopause (between 40 and 45 years); hypergonadotrophic primary amenorrhea.
Trial site: Utrecht, the Netherlands.
Anticipated trial end date: January 2015.
Effects of a fortified dietary supplement for pregnant women on maternal and newborn outcomes in Kampong Chhnang Province, Cambodia
This randomised study aims to evaluate the effectiveness in pregnant women of a daily fortified nutritional supplement, consisting of corn and soya beans mixed with 19 different vitamins and minerals, in terms of birthweight and other maternal and newborn outcomes.
Inclusion criteria: At least 18 years of age; in first trimester of pregnancy; plans to reside in the same village during the entire pregnancy.
Primary outcome measure: Mean birthweight.
Secondary outcome measures: Mean gestational weight gain; mean maternal haemoglobin level; mean birth length and head circumference.
Trial site: Kampong Chhnang, Cambodia.
Anticipated trial end date: November 2012.
South Africa: failing maternity care
A recent Human Rights Watch report has highlighted a number of failures within the South African Maternal Health Care system that have contributed to the maternal mortality rate quadrupling in the last 10 years. The South African Government has admitted that there are serious failings but unless accountability measures are enforced and improved oversight is introduced these problems are likely to continue. Maternal mortality rates continue to be indicators of a health system’s accessibility and affordability and this increase is being properly treated as a significant signal that cries for attention and resources. Issues of abuse of maternity patients by healthcare workers, substandard care, administrative and financial management problems and a lack of accountability for health system failures have all contributed to the current state of maternity provision. As a result it is unlikely that South Africa will be able to meet its Millennium Development Goal of reducing maternal mortality by 75% by 2015.