Women’s health—what’s new world wide

A patent has been granted to Inspire Pharmaceuticals for an invention that aims to increase vaginal and cervical secretions. A P2Y2 and/or P2Y4 purinergic receptor agonist will be administered at a dose that stimulates a woman’s own mucin production and secretion while also increasing levels of mucosal hydration to enhance the natural protective and lubricant functions of vaginal and cervical mucosa. This granted patent is a continuation of an application submitted in 1998. Pendergast W, Shaver SR, Drutz DJ, Rideout JL, Yerxa BR. Method of promoting cervical and vaginal secretions. Granted Patent No.: US 7432252. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_7432252#show Purinergic receptor agonists have been shown to increase both the hydration of airway epithelial cells and the mucin production; it was hypothesised that they would have a similar effect on vaginal and cervical epithelia. This would be a welcome development as vaginal dryness causes significant emotional and physical distress to many women. A patent application has been submitted for a device to be used during gynaecological laparoscopic procedures. The invention consists of a vaginal occlusion and self-adjusting delineation attachment, which can be inserted and locked into a uterine mobiliser and, with the use of a solid ring, adjusted according to the length of the cervix and the angle of the fornix. An elastic diaphragm at the base of the delineator also prevents carbon dioxide leakage from the peritoneal cavity. Valtchev KL. Vaginal Spring Loaded Delineator. Patent Application No.: US 2008/0249535 A1. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_2008/0249535_A1#show The purpose of this instrument is to provide better access to the vaginal fornices during laparoscopic procedures, making it easier for the vagina to be opened during, for example, a hysterectomy. Submitted to the World Intellectual Property Organisation International Bureau on the 9 October 2008 was a patent application relating to an invention using a formulation of oligomers of lactic acid (OMLA) to prevent and/or treat endogenous, iatrogenic or sexually transmitted infections in women. Oligomers release lactic acid when in contact with a watery environment but not all the lactic acid is released at once allowing for the maintenance of low pH over a prolonged period of time. Batcheller G, Hedner T, Johnsson J, Schubert W, Sjögren C, Sterner O, Sznitowska M. Use of oligomers of lactic acid in the treatment of gynaecological disorders. Patent Application No.: WO/2008/119518/A1. http://www.patentlens.net/patentlens/structured.cgi?patnum=WO_2008/119518_A1#show OMLAs may be beneficial in the prevention and treatment of infections such as bacterial vaginosis, which thrive in a less acidic environment. An application has been submitted relating to a method of prescribing hormonal contraception that is designed to alleviate breakthrough bleeding, principally in women of childbearing age, but also for perimenopausal and postmenopausal women. This invention provides an ascending-dose extended cycle regimen: an estrogen and a progestogen are administered, in at least three phases, for a period greater than 31 days, followed either by a hormone-free period of 2–10 consecutive days or an estrogen for 2–10 days. The daily doses of the estrogen and progestogen in the second and subsequent phases should be equal to or greater than the doses in the previous phase. Diliberti CE, Reape KZ, Bronnenkant LJ. Methods of hormonal treatment utilizing ascending-dose extended cycle regimens. Patent Application No.: WO 2008/127303 A1. http://www.patentlens.net/patentlens/structured.cgi?patnum=WO_2008/127303_A1#show Unscheduled or ‘breakthrough’ vaginal bleeding is one of the most common reasons for women to discontinue taking hormonal contraception. Although an increase in endometrial vascular fragility is almost certainly a major causative factor, little is known about the effect of exogenous steroids on endometrial vasculature. It is not clear whether the regimen proposed will necessarily prove more effective at controlling breakthrough bleeding than the multiplicity of regimens that have already been tried. Tracking Progress in Maternal, Newborn and Child Survival This report outlines the progress, obstacles and revised plans for achieving Millennium Development Goals (MDGs) 4 (child survival) and 5 (maternal health). Increased global recognition and commitment to achieve these MDGs has ensured that progress has been made; however, more radical measures are required to make achieving these vital goals a reality. The report presents data drawn from national surveys and from international databases to provide an overview of health interventions that have been successful in reducing maternal and child mortality; levels of funding; health service access inequalities and the success and failure of policies introduced to improve maternal, newborn and child health. http://www.countdown2015mnch.org/index.php?option=com_content&view=article&id=68&Itemid=61 This is a beautifully presented concise report that focuses on the progress made in achieving MDGs 4 and 5 in 68 countries where 97% of maternal, neonatal and child deaths occur. The report is also available in Spanish and French. Published by UNICEF, this report also discusses MDG 5 and focuses particularly on maternal mortality. It makes fascinating (and disturbing) reading as you take a trip around the world in its 48 pages. Detailed information and statistics are provided regarding provision of antenatal, intrapartum and postpartum care. Contraceptive and family planning services are also discussed, and fertility rate estimates are provided. The report identifies nine key programme components for maternal and newborn health and proposes that, if implemented at a country level, achieving MDG 5 is entirely possible. http://www.unicef.org/publications/files/Progress_for_Children-No._7_Lo-Res_082008.pdf These updated guidelines, developed by the New Zealand Ministry of Health National Screening Unit, contain comprehensive information on the management of women with normal, unsatisfactory and abnormal cervical smears. Guidance is included on both low- and high-grade squamous abnormalities and cervical glandular abnormalities. Recommendations for management in special circumstances such as women who are pregnant, immunocompromised or younger than 20 years of age are provided. Guidelines on human papillomavirus testing have also been included. The document has been written for all those involved in providing cervical cancer prevention services including GPs, nurses, gynaecologists, scientists and pathologists. The Screening Unit has published two online training presentations: one aimed at health professionals who take cervical smears and the other at colposcopists. http://www.moh.govt.nz/moh.nsf/indexmh/guidelines-for-cervical-screening-in-nz-oct08?Open The guidelines incorporate the results of an extensive review of evidence together with expert advice from a wide range of medical practitioners, epidemiologists and consumer representatives. They replace the 1999 guidelines for the management of women with abnormal cervical smears and incorporate key National Cervical Screening Programme policies, such as recommendations regarding the age to start screening, how often to screen and when to stop. There are a number of major changes from previous documents including the recall period for ‘low-grade’ abnormalities and more detailed guidance regarding colposcopy and follow-up care. It is especially interesting for trainees and practitioners outside New Zealand to read how the literature is interpreted in another country with a strong background in practising evidence-based medicine. Primary Health Care: Now More Than Ever The 2008 Annual World Health Report, published by the World Health Organization, focuses on Primary Health Care. Thirty years on from the declaration of Alma Ata, it emphasises the importance of primary health care and highlights the continued inequalities in the provision of health care worldwide. The report discusses the challenges posed by a changing world, increasing and supporting universal access, ensuring and promoting people-centred care, the importance of effective public health policies, leadership and effective government, and the way forward. The full text of this report is available in English, Chinese and Russian with a summary also available in Arabic, French and Spanish. A video, photographs and MP3 audio file of the launch of this report are available online. http://www.who.int/whr/2008/en/index.html This guideline, published by the Institute for Clinical Systems Improvement in the USA, provides guidance on the management of medical conditions and symptoms commonly associated with the menopause. The guideline focuses particularly on hormone therapy (HT) and the care of both current and recent past users of HT. The guideline is aimed at healthcare professionals to encourage discussion with women and to provide a process for collaborative decision-making regarding treatment and prevention strategies. It includes appendices providing information on hormone preparations and selective serotonin reuptake inhibitors, summaries of trial results and a patient handout on HT and breast health. http://www.icsi.org/menopause_and_hormone_therapy/menopause_and_hormone_replacement_therapy_ht___collaborative_decision_making_and_management_.html A comprehensive, up-to-date review of a complicated subject such as hormone replacement therapy (HRT) is always valuable, especially if it includes information designed for women. Interestingly the document uses the term HT rather than HRT to refer to treatment using estrogen, with or without a progestogen. The authors argue that as the therapy neither includes all hormones nor fully replaces them, the term HT is more appropriate than HRT. Clinicians keen to keep up to date regarding clinical trials that are currently recruiting may find the following informative. http://clinicaltrials.gov/ct2/show/NCT00777023?term=menopause&recr=Open This trial aims to assess the efficacy of an extended release formulation of gabapentin for the treatment of postmenopausal hot flushes. The following regimens of gabapentin extended release (G-ER) will be assessed: G-ER 1200 mg daily (single evening dose) and G-ER 1800 mg daily (dosed asymmetrically; 600 mg a.m./1200 mg p.m.) compared with placebo. The average daily frequency and severity score of moderate-to-severe hot flushes after 4 and 12 weeks of treatment with a stable dose will be compared with the scores at baseline. Inclusion criteria: healthy, postmenopausal women seeking treatment for at least seven moderate-to-severe hot flushes per day; women using HRT must be willing to discontinue treatment. Primary outcome measure: reduction of frequency and severity of hot flushes after 12 weeks of treatment. Trial site: USA, various states. Anticipated trial end date: June 2009. Nonhormonal preparations to treat hot flushes are eagerly sought, for example, in women with breast cancer. One drug that has been studied is gabapentin, an anticonvulsant that is used to prevent seizures and to treat postherpetic neuralgia. Its mechanism of action is not known, but structurally, it resembles the neurotransmitter gamma aminobutyric acid. There is already evidence from a small number of RCTs, suggesting that it is effective in treating hot flushes at 900 mg/day, for example Butt et al., Menopause 2008;15:310–18 and Pandya et al., Lancet 2005;366:818–24. http://clinicaltrials.gov/ct2/show/NCT00777387?term=fertility+control&recr=Open This randomised, single-blind trial aims to determine whether a higher oocyte survival rate can be achieved using the vitrification method of freezing human oocytes compared with the slow-freezing method. Inclusion criteria: 14 or more oocytes at ovum pick up; age <38 years; body mass index <30 kg/m2. Primary outcome measure: post-thaw oocyte survival rate. Secondary outcome measures: fertilisation rate, cleavage, embryo development, implantation rate and continuing pregnancy. Trial site: Ontario, Canada. Anticipated trial end date: December 2010. A 2006 meta-analysis (Oktay et al., Fertil Steril 2006;86:70–80) of oocyte cryopreservation methods concluded that in vitro fertilisation (IVF) success rates with slow-frozen oocytes were significantly lower than with fresh oocytes; the principle cause being the damage caused by the formation of ice crystals. The review also suggested that oocyte vitrification may be associated with higher success rates, and, since, there have been a number of favourable studies (e.g. Cao et al., Fertil Steril 2008; Epub ahead of print). The proposed mechanism is that vitrification causes less damage to spindle integrity and chromosome alignment. This RCT therefore aims to contribute to the growing evidence base. http://clinicaltrials.gov/ct2/show/NCT00775190?term=fertility+control&recr=Open This randomised, double-blind trial aims to compare the brand named oral contraceptive, Ortho-tricyclen, with the generic oral contraceptive, Trinessa, to assess adverse effect profiles including bleeding patterns, mood changes, nausea and vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure, stroke, blood clots and patient compliance. Women will be asked to keep a daily diary of any symptoms or bleeding that they experience and will be asked to complete a survey once a month. Inclusion criteria: nonsmoker, not pregnant, not planning to become pregnant in the next 6 months, not taking hormonal birth control for at least 3 months prior to entering the study, no history of fibroids, no history of ovarian cysts and no history of dysfunctional uterine bleeding. Primary outcome measure: bleeding patterns (breakthrough bleeding, amount of bleeding and days of bleeding [time frame: 6 months]). Secondary outcome measures: nausea and vomiting, breast tenderness, mood changes, elevation in blood pressure, stroke, blood clots, compliance and failure of contraception (time frame: 6 months). Trial site: Michigan, USA. Anticipated trial end date: May 2011. Both Ortho-tricyclen and Trinessa are triphasic pills containing ethinyl oestradiol 35 micrograms and norgestimate 180–250 micrograms; in other words, they are therapeutically equivalent, but one is branded and the other generic. http://clinicaltrials.gov/ct2/show/NCT00777556?term=fertility+control&recr=Open This noncomparative case series study aims to assess the ability of young women, aged 11–17 years, who request emergency contraception (EC) to use the EC correctly and safely without being given assistance. The EC drug being used in this study is DR-104. Inclusion criteria: female; 11–17 years of age; subject must be requesting EC for her own use and for current use; subject can read and understand English, according to her own judgement and other criteria as dictated by US Food and Drug Administration -approved protocol. Primary outcome measure: percentage of subjects who appropriately self-select DR-104 when dispensed under simulated over the counter (OTC) condition and proportion of subjects who correctly use DR-104 when dispensed under simulated OTC conditions. Secondary outcome measures: incidence of adverse events and repeat use of EC. Trial site: USA, various states. Anticipated trial end date: March 2009. EC became available OTC in the UK in 2001 but not until 2006 in the USA and only to those older than 18 years. This is therefore an interesting study, given the political sensitivities in the USA regarding these issues. http://clinicaltrials.gov/ct2/show/NCT00773825?term=pregnancy&recr=Open This observational study aims to determine if children born following assisted reproduction technology (ART) show an increased risk of imprinting defects and if so whether one of the steps in the ART procedure can be identified as causing this defect and then modified to correct this problem. The study will assess 300 children naturally conceived, 300 children conceived after ovarian stimulation and in vivo fertilisation and 300 children conceived after ovarian stimulation and IVF. The analyses will be performed on cord blood, and fragments of placental tissue will also be collected for further analyses. Inclusion criteria (mother): 26–40 years old at conception, single fetus pregnancy, signed informed consent, affiliation to French health benefits, absence of maternal pathology, normal fetal karyotype, known procedure of ovarian stimulation, ART procedure without sperm or oocyte donation, ART in a participating ART department and delivery in a participating hospital. Inclusion criteria (father): 18–50 years old at conception and signed informed consent. Primary outcome measure: assessment of the methylation status at nine imprinted loci in cord blood collected just after birth. Secondary outcome measures: assessment of other epigenetic marks (histone modifications) at imprinted loci and at nonimprinted but epigenetically regulated loci. Trial site: Paris, France. Anticipated trial end date: June 2010. Genomic imprinting (an epigenetic event resulting in monoallelic gene expression) has been associated with IVF in animals, for example Large Offspring syndrome (LOS), and humans, for example Beckwith–Wiedemann syndrome (BWS) and Angelman syndrome (AS) due to loss of methylation at ICR2 in BWS, at SNRPN in AS and at IGF2R DMR2 in LOS. These data suggest that IVF may adversely affect the establishment or the maintenance of methylation marks at maternally imprinted loci. The aim of this study, therefore, is to determine if IVF children are at increased risk of imprinting defects and which steps in the procedure may be responsible if IVF is implicated. The Guttmacher Institute reports on a study in the September 2008 issue of International Family Planning Perspectives, which highlights that there has been an increasing trend towards improving access to abortion since the last global review of policies regarding abortion 10 years ago. This has been due, in part, to the mounting concern raised internationally about the detrimental effect on women’s health and wellbeing associated with a lack of access to legal and safe abortion. The liberalisation of policies on abortion has been widespread, with 16 countries reported to have increased the grounds under which a legal abortion can take place and 10 countries increasing access to abortion services. However, in El Salvador and Nicaragua, access to legal abortion has been removed in the past 10 years. http://www.guttmacher.org/media/nr/2008/10/27/index.html