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International guidelines/reports

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  2. International guidelines/reports
  3. Clinical trial recruitment
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Breaking down the barriers

Medact (a global health charity that undertakes education, research and advocacy on the health implications of conflict, development and environmental change) has developed a free online training course and information resource for health professionals working with pregnant women and new mothers from black and minority ethnic communities. The course aims to improve access to maternity care and child health services for women in marginalised communities by helping health professionals to understand the practical, cultural and communication needs of women in these communities. The course consists of eight modules: understanding migration; maternal and child health of migrants; access to maternity services; overcoming language barriers, intercultural communication; migration and maternal mental health; improving migrant women’s experiences of maternity services. Modules consist of quizzes, reflective questions, presentations, case studies and resource lists. The modules provide a useful insight into the cultural lives of many of the women we look after. The information is relevant to all who interact with pregnant women and their families, including midwives, students, maternity care assistants and trainees.

Medicines use in primary care in developing and transitional countries

This Fact Book, published by WHO, summarises the results of a number of individual studies that have been added to the WHO database of primary care medicine use and intervention studies. The database includes all studies carried out between 1990 and 2006 in developing and transitional countries. The fact book provides a detailed summary of the use of medicines in primary care and the impact that these interventions have had over the last 20 years. It aims to (a) encourage the appropriate use of medicines in primary care and (b) help researchers, policy-makers and planners ensure that correct priority settings and targets are introduced. Topics covered include: WHO/INRUD (International Network for the Rational Use of Drugs) prescribing, patient care and health facility indicators; interventions to improve the use of medicines; discussion and recommendations. The data are largely drawn from public sector health services, where the quality of prescribing is thought to be higher than the private sector. Despite this, in all regions, less than half of all patients were treated in accordance with clinical guidelines for common diseases in primary care.

Demographic, programmatic and socioeconomic correlates of maternal mortality in Matlab, Bangladesh

This working paper, published by Pathfinder International, investigates (using the Matlab Demographic Data Surveillance System) possible associations between demographic, programmatic, and socioeconomic factors and rates of maternal mortality. Longitudinal data of almost 143 000 pregnancy outcomes during 1982–2002 were assessed in relation to answering three key questions: how is maternal mortality associated with reproductive patterns?; how does maternal mortality vary with socioeconomic factors?; do levels and trends in maternal mortality differ between the treatment and comparison areas of Matlab? Excess risk of maternal mortality was not found among teenage pregnancies, after short pregnancy intervals, or for grand multips, as may have been expected. However, maternal mortality was found to rise sharply after the age of 30. In addition, the odds of maternal mortality were 63% higher for women with pregnancy intervals longer than 5 years compared to those with 24 to 59 month intervals. This study aims to inform the development of programme strategies to make pregnancy and childbirth safer for all women in Bangladesh.

Mental health aspects of women’s reproductive health: a global review of the literature

This review, published by WHO and UNFPA, provides an overview of the available literature discussing the relationship between women’s mental and reproductive health, whilst recognising that there is little evidence available regarding the same issues in men. It aims to raise awareness of an important, emerging, public health issue: how bio-psycho-social factors increase the risks of mental health problems in women, based on data from both high and low-income countries. The psychological sequelae of events related to a woman’s reproductive life (from infertility, miscarriages and unwanted pregnancies to fistulae, dysmenorrhoea and the menopause to name but a few) are extremely variable and they can have a profound impact on the mental health of the women, and their friends, relatives and work colleagues. The review endeavours to encourage health professionals, programme managers and policy makers to discuss and implement integrated strategies to address the multiple dimensions of reproductive health.

Clinical trial recruitment

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  2. International guidelines/reports
  3. Clinical trial recruitment
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Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.

Sunitinib malate and exemestane in treating postmenopausal women with breast cancer

It is thought that sunitinib malate (a tyrosine kinase inhibitor, licensed for the treatment of advanced renal cell cancer) in combination with exemestane (an aromatase inhibitor) may halt the growth of tumour cells by blocking some of the enzymes required for cell growth. This trial aims to determine the optimum dose and possible side effects of the two drugs administered before surgery, and to measure the effect on tumour size in postmenopausal women with breast cancer.

Inclusion criteria: histologically confirmed invasive breast carcinoma meeting specific criteria: measurable disease by mammography and/or ultrasound and MRI; postmenopausal; ECOG performance status 0–1.

Primary outcome measure: recommended dose of sunitinib malate that can be combined with exemestane; objective clinical response (complete or partial response) according to WHO criteria.

Secondary outcome measures: safety and feasibility of the combination; rate of breast-conserving surgery; percentage of pathological complete response in the breast and axillary lymph nodes; extent of treatment related inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases; determination of a genetic profile (based on the analysis of CYP19A1 polymorphisms) that can predict response to neoadjuvant exemestane; molecular biomarkers predictive of response.

Trial site: Spain.

Anticipated trial end date: October 2011.

Gestational diabetes and sleep-disordered breathing

This observational study aims to determine the amount of heart rate variability in women with gestational diabetes (GDM) and to investigate whether women with GDM experience transient sleep-disordered breathing (SDB) during pregnancy.

Inclusion criteria: pregnant women, aged 18–40, at 30–34 weeks gestation.

Primary outcome measure: improvement in heart rate control two months postpartum.

Secondary outcome measures: improvement in SDB two months postpartum.

Trial site: Delaware, US.

Anticipated trial end date: not specified.

Heiskanen et al. (J Diabetes Complications 2009 March 11 epub) found that pregnancy affected cardiovascular autonomic regulation equally in women with and without GDM in the third trimester and three months postpartum. The planned study will only examine women with GDM, but heart rate variability before and after delivery will be measured as well as sleep disordered breathing, which is thought to be more prevalent in this group of women.

Effect of high testosterone on sleep-associated slowing of follicular luteinising hormone (LH) frequency in polycystic ovary syndrome (CRM004)

Luteinising hormone pulse frequency decreases during sleep in the follicular phase, which is important for normal FSH production and secretion. However, the decrease does not always occur in women with polycystic ovary syndrome (PCOS). This randomised, double-blind, trial aims to investigate whether a testosterone receptor blocker, flutamide, will regulate sleep-wake LH pulse frequency relationships in women with PCOS. It is anticipated that the nocturnal decrease in pulse frequency will also be observed. Women will be assessed after receiving flutamide (or placebo) for 4 weeks and again 4 weeks after cross-over. The results will be analysed to determine differences in the LH pulse frequency of women with PCOS and normal controls.

Inclusion criteria: 18–35 years-old; no significant health problems (other than PCOS and obesity); willing to use nonhormonal contraception in the study; controls will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism; PCOS will be defined according to NIH consensus criteria.

Primary outcome measure: LH pulse frequency (awake and asleep).

Secondary outcome measures: hormone and biochemical tests; sleep study parameters.

Trial site: Virginia, US.

Anticipated trial end date: January 2014.

Anti-mullerian hormone (AMH) and antral follicle count as markers of ovarian reserve – prospective follow up of young cancer patients (ovrescancer)

Survival rates for young female cancer patients are increasing; however, damage to ovarian reserve during treatment impacts on future fertility. This observational study aims to identify markers of ovarian reserve in young female cancer patients by determining the gonadotoxicity of different cancer treatments.

Inclusion criteria: females, aged 5–45, having chemotherapy.

Primary outcome measure: AMH levels.

Secondary outcome measures: antral follicle count; FSH; Inhibin B; menstrual history; estradiol and progesterone.

Trial site: Jerusalem, Israel.

Anticipated trial end date: December 2011.

For readers interested in the subject, an excellent review article has just been published on the effects of cancer treatment on ovarian function: Stroud et al. Fertil Steril 2009;92:417.

Patent news

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Granted patents

US 7560122 Pharmaceutical dosage form bearing pregnancy-friendly indicia. This granted patent relates to an invention designed to improve patient compliance with recommended dosage regimens during pregnancy. It also aims to reduce the incidence of erroneous dispensing or ingestion of drugs contraindicated in pregnancy. The invention involves a dosage form that includes graphical ways to differentiate regimens intended for use in pregnancy.

Pole et al. (J Clin Pharmacol 2000;40:573–7) found that it is not only pregnant women who suffer anxiety about the safety of medications in pregnancy, but also healthcare professionals who prescribe and dispense the drugs. Therefore, a way to provide appropriate clarity and reassurance to pregnant women and practitioners might be useful. Related application: US 20040091526 A1 (20040513).

Gervais, É, Atanackovic, G, Hebert, R. Pharmaceutical dosage form bearing pregnancy-friendly indicia. 14 July 2009.

EP 1524321 B1 Non-invasive detection of fetal genetic traits. This granted patent relates to methods to detect fetal genetic traits using non-invasive means. It has been previously established that extracellular fetal DNA is present in the maternal circulation. Extracellular fetal DNA is relatively small, consisting of approximately 500 base pairs or less, whereas maternal extracellular DNA is greater than 500 base pairs. Selective isolation of the fetal DNA allows for the analysis of fetal genetic traits, including chromosomal disorders, to be carried out in a non-invasive manner.

Hahn, S, Zimmermann, B, Holzgreve, W, Li, Y. Non-invasive detection of fetal genetic traits. 1 July 2009.

Patent applications

US 2009/0173340 A1 Method and apparatus to relieve menstrual pain. This patent application relates to an alternative method and apparatus for relieving menstrual pain. The invention specifically relates to the application of 10 to 15 pounds of pressure by tapered pads strapped to the hips, which are kept in place for as long as the pain continues and for 5 to 10 minutes after it has gone. The pressure is applied to the area around the greater trochanter of the femur. It is hoped that compression of the area adjacent to the greater trochanters will allow the ligaments and tendons next to the uterus to relax and thus help reduce menstrual cramps.

LEE, SD. Method and apparatus to relieve menstrual pain. 9 July 2009.

US 2009/0186367 A1 Diagnosis of fertility conditions using a serine protease. This patent application relates to a method for evaluating early implantation and placentation: specifically, a method for measuring pregnancy-related serine protease (PRSP) protein between 7 and 20 weeks of pregnancy. This is based on experiments in mice and monkeys suggesting that serine proteases are important for successful implantation (Bowden et al. Reprod Biol Endocrinol 2008;6:22)

`Levels of this protein will be measured in women with a normal pregnancy and in those who are unable to sustain implantation, or who have features of abnormal placentation (pre-eclampsia, IUGR). Nie, G, Salamonsen, LA. Diagnosis of fertility conditions using a serine protease. 23 July 2009.

Related application: Provisional application No. 61/015,956, filed on Dec. 21, 2007.

WO 2009/078953 A1 Endoscopic mesh delivery system with integral mesh stabiliser vaginal probe. This patent application relates to a mesh delivery system for sacral colpopexy procedures, which consists of a mesh stabiliser; an endoscopic introducer to insert the stabiliser into the abdomen, and a vaginal probe inserted into the vagina, consisting of a head that is ‘locked’ into the mesh stabiliser. The stabiliser is used to attach the mesh straps; the endoscopic introducer is then removed to allow suturing. Thereafter, the introducer is reinserted to facilitate the retrieval of the mesh stabiliser.

Pechmann, W. Von., Yoon, SC., Lipford, K., Lipford, B., Cox, A. Endoscopic mesh delivery system with integral mesh stabiliser vaginal probe. 25 June 2009.

Legal matters

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  2. International guidelines/reports
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Saudi Arabia: women’s rights promises broken

Saudi Arabian laws that require women to gain the permission of their guardians before they can carry out a range of day-to-day pursuits have come under the spotlight recently. Guardianship laws restrict access to education, employment, travel and medical care to women unless they have the permission of their husbands, fathers, or male children. It has been reported that the Health Ministry requires women seeking medical treatment, such as elective surgery, to have permission, resulting in women being unable to make decisions about their own health. This situation undermines the UN Convention on the Elimination of all Forms of Discrimination ratified by Saudi Arabia in 2001. The Saudi government denies the existence of guardianship requirement laws within the country.