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
Young and healthy: special issue
This special issue of the European Magazine for Sexual and Reproductive Health is published by the World Health Organization (WHO) Regional Office for Europe, in conjunction with NHS Health Scotland and the International Planned Parenthood Federation (IPPF) European Network. It brings together a variety of research studies, reports and opinion papers about the delivery of sexual and reproductive health services to young people. These include: United Nations Population Fund’s commitment to advancing the rights of adolescents and youth in Eastern Europe and central Asia; guidelines for developing national policies addressing the sexual and reproductive health needs of young people; the role of the internet and emerging new technologies; engaging and involving young people, and reaching those most at risk. The papers highlight the need for a more positive and engaging approach to the provision of sexual and reproductive health services to young people.
Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills
The International Consortium for Emergency Contraception, IPPF and the WHO Department for Reproductive Health and Research, in conjunction with International Federation of Gynecology and Obstetrics (FIGO), have recently published a fact sheet providing an overview of the levonorgestrel-only emergency contraceptive pill, including its safety profile. It also contains a discussion about whether this form of emergency contraception encourages more sexual risk-taking behaviour. The report concludes that the pill is safe: in particular, it does not induce abortion, harm future fertility or have a high incidence of adverse effects. Full guidance about the provision of emergency contraception in the UK can be found online at the Faculty of Sexual and Reproductive Healthcare (http://www.ffprhc.org.uk).
Investing wisely in child survival with the lives saved tool (LiST)
LiST, the ‘Lifes Saved Tool’, is an evidence-based instrument for assessing the impact of an intervention upon maternal, neonatal and child health outcomes. Using a programme called spectrum (which can be downloaded from http://www.jhsph.edu/dept/ih/IIP/list/spectrum.html), the tool allows users to set up and run multiple scenarios (involving different interventions) and calculates the likely impact of these interventions within the country or region. The tool integrates effectiveness information relating to the intervention, mortality rates and current intervention coverage. It is aimed at managers and policy-makers so as to support policy planning and implementation.
Interagency field manual on reproductive health in humanitarian settings
Compiled by a number of international organisations, this field manual for delivering reproductive health services to refugees, internally displaced persons and others living in humanitarian settings has recently been updated. The information provided is based on WHO technical guidance and good practice that has been reported in crisis settings around the world. Access to comprehensive information and reproductive health services is a basic human right but many people affected by crisis are still exposed to life-threatening, reproductive health events. The manual states that people can be displaced for an average of 17 years; therefore, provision of multisectoral, integrated reproductive services in crisis situations is vital in preventing death, disease and disability.
WHO laboratory manual for the examination and processing of human semen
The fifth edition of the WHO laboratory manual for the examination and processing of human semen has recently been published in response to new evidence, and the need to provide additional supporting evidence and more detailed explanations. The manual includes guidelines regarding: semen analysis; optional and research procedures; sperm preparation techniques; sperm cryopreservation; and quality assurance and control in the laboratory. It includes standard reference ranges for reporting semen characteristics to enable comparison of results between laboratories.
Clinical trial recruitment
Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.
The effect of hormonal contraceptives on androgens and glucose metabolism
This prospective randomised trial aims to investigate the impact of different routes of administration of hormonal contraceptives on androgen secretion, glucose metabolism and inflammation. Serum sampling and oral glucose tolerance measurements will be carried out before and after 9 weeks of medication. The contraceptives included in this study are: the desogestrel–ethinyl estradiol pill, the etonogestrel–ethinyl estradiol vaginal ring and the norelgestromin–ethinyl estradiol patch.
Inclusion criteria: healthy women aged 20–35 years; regular menstruation; no use of hormonal contraception or a 2-month wash-out period.
Primary outcome measures: androstenedione, testosterone, dehydroepiandrosterone sulphate, sex hormone binding globulin and C-reactive protein levels.
Secondary outcome measures: oral glucose tolerance test at 0 and 9 weeks; fasting glucose, insulin and c-peptide at 5 and 10 weeks.
Trial site: Oulu, Finland.
Anticipated trial end date: December 2010.
Up–down determination of the ED90 of metaraminol to treat hypotension during caesarean section
This double-blind, randomised study aims to determine the most effective dose of metaraminol for treating hypotension after spinal anaesthesia for elective caesarean section. Baseline systolic blood pressure (SBP) will be determined before caesarean section. The SBP will be measured every minute during the period from administration of spinal anaesthesia to delivery, with metaraminol administered each time the SBP is lower than the baseline value. In other words, bolus doses will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose–response curve to estimate the 90% effective dose (ED90).
Inclusion criteria: aged > 18 years; elective caesarean section under spinal anaesthesia; normal singleton pregnancy >36 weeks of gestation; ASA 1–2.
Primary outcome measure: ED90 of metaraminol to treat hypotension in elective caesarean section.
Secondary outcome measures: maternal demographics; incidence of nausea and vomiting; times between skin/uterine incision and delivery; total dose of metaraminol; number of participants with hypertension or bradycardia as a measure of safety and tolerability; umbilical blood gases; Apgar scores.
Trial site: São Paulo, Brazil.
Anticipated trial end date: August 2010.
Sequential short versus long, clinical study synopsis in assisted reproductive technology
This observational study aims to assess the efficacy and tolerability of different regimens used in in vitro fertilisation (IVF) treatment: recombinant follicle stimulating hormone (rFSH) only; rFSH and highly purified, human-derived FSH (Fostimon); Fostimon only. The study is based upon the findings of two small trials that suggest it is advantageous to commence ovarian stimulation with a highly glycosylated FSH (e.g. Fostimon), followed 1 week later by a low glycosylated FSH (e.g. rFSH), thereby mimicking normal physiology (Pacchiarotti et al., J Assist Reprod Genet 2007;24:400–5; Selman et al., Fertil Steril 2009 Nov 23. [Epub ahead of print]).
Inclusion criteria: aged 18–42 years; first IVF attempt; BMI 18–25; basal FSH < 12 (if aged <35 years) or <15 (if aged >35 years).
Trial site: Shandong, China.
Anticipated trial end date: October 2010.
Study of oral ENMD-2076 administered to women with ovarian cancer
This interventional study aims to assess the efficacy of oral ENMD-2076 in treating women with platinum-resistant ovarian, fallopian or peritoneal cancer. ENMD-2076 325 mg daily will be administered orally to women in 28-day continuous cycles. ENMD-2076 is a novel inhibitor with potent activity against Aurora A and multiple tyrosine kinases linked to cancer and inflammatory diseases. Aurora kinases are key regulators of mitosis and are often overexpressed in cancers. ENMD-2076 exerts its effects through multiple mechanisms of action, including antiproliferative activity and inhibition of angiogenesis.
Inclusion criteria: aged > 18 years; histological diagnosis of ovarian, fallopian or peritoneal cancer with proven platinum resistance; prestudy left ventricular ejection fraction greater than or equal to the institution’s lower limit of normal.
Primary outcome measure: progression-free survival rate.
Trial site: Ontario, Canada.
Anticipated trial end date: December 2011.
EP 1891204 B1 Method of fetal cell enrichment. This European granted patent discusses a method by which a maternal blood sample can be enriched to ensure that an analysable sample of fetal cells can be obtained.
Isolating the CD34+ population of cells from maternal blood and then selecting those cells capable of adhering to a solid support, obtains a significant and clinically useful proportion of fetal cells for analysis. This facilitates noninvasive diagnostic methods, potentially avoiding the risk of miscarriage associated with amniocentesis and chorionic villus sampling.
Levicar N, Gordon M. Method of fetal cell enrichment. 7 April 2010.
US 7700280 Methods for assessing cisplatin resistance, disease progression and treatment efficacy in ovarian cancer. This granted patent discusses methods for predicting whether ovarian cancers will be resistant to cisplatin. Variation in expression of genes within groups S100A10 and S100A11 is used to identify tumour cells resistant to standard chemotherapeutic treatment. The inventors also describe a technique for reducing drug resistance and a means of monitoring the effectiveness of cancer treatment. The S100 gene family includes at least 13 members located as a cluster on chromosome 1q21. S100 proteins are localised in the cytoplasm and nucleus of a wide range of cells. They regulate a number of cellular processes such as cell cycle progression and differentiation.
Al-Murrani, S. Methods for assessing cisplatin resistance, disease progression, and treatment efficacy in ovarian cancer. 20 April 2010.
US 2010/0100035 A1 Uterine stimulant sticks. This US patent application discusses a ‘uterine stimulant’ consisting of a ratio of ichthammol, oak milk and blue vitriol, impregnated into a thin stick, which is inserted into the gravid uterus with the help of a dilator to induce or augment labour; help uterine contractions following a miscarriage; induce abortion; reduce haemorrhage following childbirth or abortion. Ichthammol (ammonium bituminosulphonate) is used as a remedy for treating acne, eczema and psoriasis.
Kataria, O. Uterine stimulant sticks. 22 April 2010.
US 2010/0106024 A1 Method for diagnosing vulvovaginal disorders. This patent application describes a diagnostic method for vulvovaginal disorders. Specifically, this method involves using a cross-polarised light to illuminate the vulvovaginal area so that any subsurface irritations can be visualised.
Farage, M. Method for diagnosing vulvovaginal disorders. 29 April 2010.
G8: Act to improve maternal and child health
Development ministers from around the world are meeting in Canada to lay the foundation for the June 2010 G8 meeting. It has been argued that the G8 should make it a priority to address access to sexual and reproductive health care; promote health system accountability, and increase health financing. Many governments worldwide have avoided basic healthcare system reforms resulting in poor health outcomes for their populations.
Abortion care guidelines released in India
The Indian government strengthened its commitment to safe abortion on 12 April 2010 when it released comprehensive new training and service delivery guidelines for providing abortion care in India. These aim to improve and increase access to safe abortion services; they also address the lack of trained abortion providers throughout the country.