Women’s health—what’s new worldwide

A US patent, granted to the Maruha Corporation and the Osaka Bioscience Institute, relates to pregnancy-induced hypertension. The patent describes a novel method to detect abnormalities that occur before the onset of pregnancy-induced hypertension while not imposing unduly upon patients. The method that has been granted is for detecting the levels of human lipocalin-type prostaglandin D synthase (L-PGDS) in a fluid sample collected from the pregnant woman for determining the severity of and predicting pregnancy-induced hypertension. Oda H, Seiki K, Shina Y, Sato N, Takeda S, Eguchi N, Urade Y. Method for predicting pregnancy-induced hypertension. Granted Patent US7399596. 15 July 2008. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_7399596#show Lipocalin-type L-PGDS, which is responsible for the biosynthesis of prostaglandin D2, is present in atherosclerotic plaques and detectable in serum. It has been previously proposed as a biomarker for essential hypertension and cardiovascular disease. The US Patent Office have granted a patent to Impres Medical Inc. relating to the use of a nonrigid intrauterine implant for creating intrauterine adhesions that result in amenorrhoea. The intrauterine implant can be positioned easily to bring about the reduction or elimination of abnormal uterine bleeding. This implant for treating menorrhagia is claimed to be an alternative to conventional hysterectomy or procedures that ablate or resect the endometrium. Duchon D, Presthus J. Method and apparatus for creating intrauterine adhesions. Granted Patent US 7406969. 5 August 2008. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_7406969#show The company is focused on developing a simple office procedure called Elate™ to stop menstrual bleeding; however, the precise nature of the implant that induces intrauterine adhesions is unclear. A European patent was granted to Shionogi & Co. Ltd for uterine contraction inhibition. The patent relates to the use of a composition containing adrenomedullin for inhibiting spontaneous myometrial or bradykinin-induced contractions. The composition can be used to prevent premature labour or miscarriage, stop contractions before commencing a caesarean section or to treat dysmenorrhoea. Yanagita, T. Uterine contraction inhibitors. Granted Patent EP 1205185 B1. 6 August 2008. http://www.patentlens.net/patentlens/structured.cgi?patnum=EP_1205185_B1#show Adrenomedullin is an almost ubiquitous peptide. In isolated rat uterine strips, it has been shown to inhibit spontaneous periodic and bradykinin-induced contractions in a dose-dependent manner. Of interest to fertility specialists is a European patent, granted to Laboratoires Serono, to use follicle-stimulating hormone (FSH) for treating infertility. The patent relates to the production of ‘a medicament for the treatment of infertility in females using FSH and/or a biologically-active analogue thereof’. During the stimulation phase, the medicament would be administered at an initial dose ranging from 100 to 600 iu and a second dose would be given at a minimum of 3 days later. The medicament, in one formulation, is for a dose in the range of 300–600 iu every third day for the first 6 days of stimulation and in another formulation is for an initial dose in the range of 100–500 iu with a second dose being administered between 3 and 6 days, but preferably 4 days after the initial dose. Loumaye EG, Duerr-Meyers L. Use of FSH for treating infertility. Granted Patent EP 1250148 B2. 2 July 2008. http://www.patentlens.net/patentlens/structured.cgi?patnum=EP_1250148_B2#show This 2008 interagency statement by OHCHR, UNAIDS, UNDP, UNESCO, UNFPA, UNHCR, UNICEF, UNIFEM and WHO builds upon decades of action by local communities, governments, and national and international organisations to reduce the prevalence of female genital mutilation. Limited success, however, has been achieved and this statement is a call to all States, national and international organisations and communities to strengthen their policies, laws, work and support to eliminate the practice. A similar statement was issued in 1997, but this revised version has support from a wider range of agencies. It is also based on new evidence that has come to light over the last decade, in particular that neonatal outcomes are worse following birth to women who have been mutilated, with the severity of the outcome worsening with the extent of mutilation. The statement provides the framework required to work towards eliminating the practice worldwide, emphasises both the human and legal issues surrounding the problem, and reports the results of research investigating why the practice continues and the impact it has on the health of women and girls. http://www.unfpa.org/publications/detail.cfm?ID=361=1 This statement makes fascinating reading with a particularly thought-provoking section on the reasons why some healthcare workers continue to perform such brutal procedures. This WHO Social Science Research Policy Brief, published in February 2008, outlines a study, conducted in South Africa and Vietnam (and initially published in the Lancet in 2006) to compare the safety of first-trimester abortion (termination of pregnancy) using manual vacuum aspiration carried out by nurses, midwives, mid-level healthcare providers and doctors. At present, both countries routinely train mid-level healthcare providers to perform first-trimester termination of pregnancies (TOPs). The complication rates were compared by provider type to a preset range of expected complication rates derived from previous procedures. The study concluded that first-trimester TOPs were just as safe and acceptable if carried out by mid-level healthcare providers as by doctors. It is hoped that these results will impact upon the extent of access to safe TOPs in countries where the law permits first-trimester termination of pregnancy by providing increased access to such services. http://www.who.int/reproductive-health/hrp/policy_briefs/midlevel_hcproviders.pdf This is the first study to compare the safety of TOP carried out by different providers in developing countries and its findings should prompt healthcare organisers in similar situations to consider whether their current system makes best use of staff and resources available. Published in June 2008, this manual, part of Pathfinder International’s training curriculum, has been developed to provide a comprehensive training course for local government health teams. This will enable the teams to use evidence-based methods to develop their own long-term plans for improving their reproductive health programmes. The manual has been designed so that it can be adapted for different settings to meet the needs of country-specific health issues. A training schedule, as well as handouts and exercises for each session, are provided. Participants are encouraged to create an action plan to detail how the principles and practices learned during this course will be applied practically at the local level. On-site coaching, mentoring and follow up can also be provided to help ensure that evidence-based planning is being adopted. http://www.pathfind.org/site/DocServer/evidence_based_planing.pdf?docID=12042 The manual provides a comprehensive basic training course for planning health programmes that could also be adapted to programmes other than reproductive health. The Society of Gynaecologists and Obstetricians of Canada have recently produced a technical update describing new molecular techniques for the prenatal detection of chromosomal aneuploidy. Published in July 2008 by their Genetics Committee, the document provides an overview of the currently available genetic techniques for rapid prenatal diagnosis of fetal aneuploidy. These include fluorescence in situ hybridisation and quantitative fluorescence polymerase chain reaction. A UK Health Technology Assessment appraised these methods in 2003 but did not cover the newer technique of multiplex ligation-dependent probe amplification that is discussed in this article. http://www.sogc.org/guidelines/documents/gui210TU0807.pdf This is a concise, well-written summary of the molecular genetic methods currently available for prenatal diagnosis. Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative. http://clinicaltrials.gov/ct2/show/NCT00737984?term=Infertility=Open=08%2F08%2F2008=1000 This study aims to determine whether performing endometrial sampling before intrauterine insemination with superovulation improves the pregnancy rate. Both endometrial sampling and superovulation with gonadotrophins will be undertaken in standard ways. Endometrial sampling, using a Pipelle catheter, will take place during the follicular phase, not later than day 10 of the woman’s cycle; specimens will be sent for histopathological examination. Inclusion criteria include: all women undergoing superovulation with gonadotrophins and intrauterine insemination; all women with cervical factor, mild male factor and/or unexplained infertility; and at least one patent fallopian tube. Exclusion criteria: bilateral tubal disease; severe male factor infertility; intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions); women with positive cervical culture and/or acute vaginal infection. Primary outcome measure: rate of clinical pregnancy (time frame = 18 months) Trial site: Quebec, Canada Anticipated trial end date: August 2009 The idea that disturbing the endometrium before assisted reproduction improves pregnancy rates is not new, but it is counterintuitive and controversial. This study will add evidence to the small, existing knowledge base. http://clinicaltrials.gov/ct2/show/NCT00740428?term=urinary+female=Open=08%2F18%2F2008=1000 This trial aims to determine the effectiveness of pelvic floor exercises during pregnancy on pelvic floor muscles and urinary continence. The study also hopes to determine if exercise changes pelvic floor muscle function and if the occurrence of urinary incontinence is reduced by changing pelvic floor muscle function. A manual, detailing recommended exercises, will be given to those in the intervention group and will be backed up by supervision from a physical therapist. The manual will be assessed to determine if it is well accepted and easily understandable, and if the intervention is reproducible. Inclusion criteria: aged between 20–35 years, pregnant for the first time, and no previous experience of urinary loss episodes before pregnancy. Exclusion criteria: previous pregnancy. Primary outcome measure: urinary incontinence reduction [time frame = 12 months] Secondary outcome measures: pelvic floor muscle dysfunction reduction [time frame = 12 months] Trial site: Sao Paulo, Brazil. Anticipated trial end date: July 2009. http://clinicaltrials.gov/ct2/show/NCT00734812?term=female+pain+disorders=Open=08%2F08%2F2008=1000 This randomised, single blind trial aims to determine if the recovery time and return to normal activities differ following a laparoscopic supracervical hysterectomy (LSH) compared with a total laparoscopic hysterectomy (TLH). Patients will be randomly assigned to have either an LSH or TLH. They will complete a quality of life questionnaire (Short Form-36 Health Survey), a sexual function questionnaire (FSFI) and a short questionnaire about urinary function (3IQ) preoperatively, as well as 6 weeks and 6 months after the operation. Patients will also be asked to keep a diary of pain symptoms and use of narcotics following surgery until they have resumed normal activities, and they will be asked questions about urinary symptoms and persistent vaginal bleeding. Inclusion criteria: candidates for laparoscopic hysterectomy for benign indications. Exclusion criteria: malignancy of the uterus, cervix or adnexa; premalignant changes of the uterus, cervix or adnexa; and history of severe cervical dysplasia (cervical intraepithelial neoplasia II or above). Primary outcome measure: return to normal activities (time frame = 6 months after surgery) Secondary outcome measures include: sexual function (time frame = 6 months after surgery) Trial site: Boston, Massachusetts Anticipated trial end date: December 2011 Although subtotal and total hysterectomies at open surgery have been compared before, there have been few studies comparing the laparoscopic approaches. http://clinicaltrials.gov/ct2/show/NCT00740831?term=female+pain+disorders=Open=08%2F18%2F2008=1000 This trial aims to determine the safety and efficacy, over a 3-month period, of PGL4001—an orally active, selective progesterone receptor modulator (SPRM)—versus a gonadotrophin-releasing hormone (GnRH) agonist for the preoperative treatment of heavy uterine bleeding as a result of uterine fibroids in premenopausal women. Inclusion criteria: premenopausal women between 18 and 50 years; excessive uterine bleeding because of fibroids; a fibroid uterus with at least one fibroid of ≥ 3 cm diameter; eligible for a surgical procedure such as hysterectomy or myomectomy; if using contraception the woman must be using a nonhormonal method; and body mass index ≥18 and ≤40. Exclusion criteria: history of/current uterine, cervical, ovarian or breast cancer; history of/current endometrial atypical hyperplasia or adenocarcinoma; known severe coagulation disorder; history of/current treatment with a SPRM or GnRH agonist for fibroids; history of/known current osteoporosis; abnormal hepatic function at study entry; positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study; current (within twelve months) problem with alcohol or drug abuse; and currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days. Primary outcome measure: to compare the efficacy of PGL4001 versus GnRH agonist to reduce excessive uterine bleeding [time frame = 3 months]. Secondary outcome measures: improvement over baseline in fibroid-related symptoms such as impaired quality of life and pain; to assess PGL4001 capacity to decrease uterine and fibroid volume [time frame = 3 months]. Trial site: Brussels, Yvoir and Liege, Belgium. Anticipated trial end date: January 2010. Numerous studies have been conducted in the past assessing the role of GnRH agonists for this indication. Selective progesterone receptor modulators have not been extensively investigated; however, such a drug could be used for long-term management of uterine fibroids as well as preoperatively if it is effective and its adverse effect profile is acceptable. Throughout Latin America, there is fierce legal and political debate regarding induced abortion (TOP) and this new ruling from the Mexico Supreme Court will certainly add to that debate. The ruling, which upholds the law introduced in Mexico City in April 2007, legalises TOP upon request up to 12 weeks of pregnancy and was arrived at after the courts held a series of six public meetings to hear petitions from groups both in favour of, and opposed to, the law. Following this, the court rejected the constitutional challenge and issued its decision—a move that has been seen as transferring the debate about legal abortion into the field of women’s rights. http://www.ipas.org/Library/News/News_Items/Mexican_Supreme_Court_upholds_Mexico_City_abortion_law_by_overwhelming_majority.aspx The Tom Lantos and Henry J. Hyde United States Global Leadership against HIV/AIDS, Tuberculosis and Malaria Reauthorisation Act became law on 31 July 2008. Signed by President Bush, the law allows Congress to increase radically the support provided by the US to combat HIV/AIDS worldwide. The act, which builds on a previous programme known as the President’s Emergency Plan for AIDS Relief (PEPFAR), permits Congress to allocate $48 billion over 5 years—but these funds must still be appropriated within the Fiscal Year 2009 budget process, a restriction that has resulted in protests from a number of organisations. The new law has also raised concerns regarding the requirement to force PEPFAR recipients in both the US and worldwide to adopt an organisation-wide policy to oppose prostitution to secure funding. This restriction has prompted the Southern District of New York District Court to appeal on the grounds that it is unconstitutional. http://www.pathfind.org/site/PageServer?pagename=News_PEPFAR_073108 While the increase in funding as a result of the Act is greatly welcomed, does its focus on abstinence rather than sexual education and its lack of integration with family planning services reduce the impact that could otherwise have been made, particularly in developing countries?