Women’s health—what’s new worldwide

EP 1534155 B1: Obstetric vacuum extractor. This invention relates to an improved obstetric vacuum extractor, consisting of a hard polymer suction cup that can be locked to, and detached from, a traction handle made from a flexible, nonelastic material. The device will need to be attached to a suction pump. This will be an improvement on current methods as it can be adapted to the needs of a particular situation: there will be a range of connector devices (ball and cylinder) allowing rotation in all or limited directions, and the traction handle will have variable lengths. It will also be disposable and probably cheap to produce. http://www.patentlens.net/patentlens/structured.cgi?patnum=EP_1534155_B1#show US 7462157: Method and apparatus for detecting endometriosis. This granted patent relates to a nonsurgical method of detecting endometriosis. The invention consists of a probe fitted with a metal sensor that detects the presence of ferrous-laden endometriotic tissue. The probe can be inserted into the vagina or peritoneal cavity. An electronic circuit attached to the sensor detects and interprets the changes in current or voltage as either qualitative or quantitative measurements of the amount of ferrous-laden tissue present. Interpretation of the readings can result in positive identification of the early onset or progression of endometriosis or the effectiveness of therapies for the condition. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_7462157#show There is a pressing clinical need to develop a noninvasive diagnostic test for endometriosis given the well-established delay between the onset of symptoms and a surgical diagnosis in most countries around the world. A number of methods have been proposed in the past, none of which have entered clinical practice. Little information is available about this invention, but it presumably relies on the fact that excess iron has been demonstrated in endometriotic lesions, peritoneal fluid and macrophages of patients with endometriosis. Interestingly, it has been suggested that iron overload might affect a wide range of mechanisms involved in endometriosis development, such as oxidative stress and lesion proliferation (Mol Hum Reprod 2008; 14:377). US 2008/0306346 A1: Diagnostic tool detecting the degradation status of Von Willebrand Factor multimers. This patent application relates to the invention of a diagnostic tool to detect those at risk of developing inflammatory, infectious and/or coagulation problems caused by altered thrombogenic activity of Von Willebrand Factor (VWF). VWF is a protein involved in platelet adhesion and thrombus formation, and lack of it causes a bleeding disorder. However, it is also an early marker of endothelial injury and dysfunction, and high levels are associated with increased risk of death from severe sepsis. The tool will provide a method, using spectroscopy, by which the degradation status of VWF multimers can be determined, which will aid in the diagnosis of patients with the above conditions as well as the determination of disease severity and prognosis. Claus RA, Bockmeyer C, Deigner HP, Harz M, Roesch P, Popp J, Riesenberg R. Diagnostic tool detecting the degradation status of Von Willebrand Factor multimers. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_2008/0306346_A1#show US 2008/0300219 A1: Novel interstitial therapy for immediate symptom relief and chronic therapy in interstitial cystitis. This invention aims to reduce the symptoms of interstitial cystitis. A formulation consisting of heparin, local anaesthetic and a buffering solution is anticipated to relieve the symptoms of interstitial cystitis, including urinary frequency, urgency and/or pelvic pain. Current treatment regimens are ineffective in many patients, and it is thought that a multimodal therapy may produce immediate and long-term symptom relief. This therapy focuses on restoring lower urinary tract epithelium with heparin and decreasing neural activation with local anaesthetic. The application is based on US patent application Ser. No. 11/045,411. http://www.patentlens.net/patentlens/structured.cgi?patnum=US_2008/0300219_A1#show A recent Cochrane review of intravesical treatments for Painful Bladder Syndrome/Interstitial Cystitis concluded that the evidence base was limited for the use of the six treatments identified: resiniferatoxin, dimethyl sulphoxide, BCG, pentosanpolysulphate, oxybutin and alkalinisation of urine (Cochrane Database Syst Rev 2007;CD006113). This invention, however, is presumably based on the results of a small, nonrandomised, observational study, which showed some symptom relief in patients treated with a 15 ml intravesical instillation of 40 000 U heparin, 1 or 2% lidocaine and 8.4% sodium bicarbonate (Urology 2008;71:67). WO 2008/143406 A1: Trichomonas vaginalis diagnostic kit. This patent application relates to a diagnostic kit for detecting Trichomonas vaginalis, a sexually transmitted protozoan. The test employs anti-T. vaginalis antibodies produced by animals immunised with T. vaginalis excretory–secretory products. Current methods for diagnosis include microscopy, culture or polymerase chain reaction, but these have various drawbacks including delay in producing a result and expense. It is claimed that this antibody-based technique could produce a result in under an hour with high predicted specificity (99%) and sensitivity (85%). http://www.patentlens.net/patentlens/structured.cgi?patnum=WO_2008/143406_A1#show Published in November 2008 by the Women’s Health Council in Ireland, this review brings together the latest evidence on treatments, including surgery, chemotherapy, hormone therapy, biological therapy and radiotherapy for breast, ovarian and cervical cancers. This review also considers the effects of treatment on fertility and discusses fertility preservation measures, such as cryopreservation, ovarian transposition and gonadal shielding. It makes fascinating reading and is highly recommended to anyone who would like an overview of current treatment strategies and advances in the management of these conditions. Mortality and survival data for women across Europe (and in Ireland in particular) are also presented and comparisons between Europe and Ireland are discussed. http://www.whc.ie/documents/40_cancerTreatment.pdf Launched in December 2008, this report focuses on critical issues in primary health care in South Africa over the past 30 years; in particular, STIs, HIV and maternal and newborn health. An overview of the implementation of the 2008 National Health Act and the progress of a number of National Health Amendment Bills is provided. The report also reviews the concept of Primary Health Care and considers this from an international perspective. It is a comprehensive report that gives readers an insight into the challenges affecting provision of health care in South Africa. Interestingly, the prevalence of HIV in antenatal clinics reached a peak of 30% in 2005, and although it fell to 28% in 2007, it is thought that the Millennium Development Goals for maternal and child mortality are unlikely to be met due to the impact of HIV in the country. http://www.hst.org.za/uploads/files/sahr2008.pdf The Society of Obstetricians and Gynaecologists of Canada have recently published new guidelines on missed or delayed hormonal contraceptives. These guidelines aim to ensure that clinicians can offer clear, concise and up-to-date information to women who have failed to take hormonal contraceptives at the correct times. Recommendations include providing telephone/electronic reference services for women and giving clear instructions during contraceptive counselling appointments. http://www.sogc.org/guidelines/documents/gui219ECO0811.pdf This report (co-published by Childbirth Connection, the Reforming States Group and the Milbank Memorial Fund) aims to influence clinical policy decisions in maternity care in the USA. The report discusses barriers to the implementation of evidence-based maternity care, current performance and expenditure and overused and underused interventions. The principles of evidence-based practice are outlined as well as the challenges that exist to fill the current evidence gaps to ensure that women in the USA are provided with the best possible maternity care. http://www.milbank.org/reports/0809MaternityCare/0809MaternityCare.html This report is well written and includes some fascinating information. For example, in the 25 years from 1981 to 2006, the national rate of preterm birth increased by 36% and the proportion of low birthweight babies increased by 22%. Following a steady decrease through most of the 20th century, maternal mortality stagnated from 1982 to 1998. Changes in how maternal mortality is measured in 1999 and 2003 make it difficult to compare the most recent years with the period to 1998; nevertheless, the national maternal mortality rate was 8/100 000 live births in 1998 and 13/100 000 live births in 2003. Clinicians keen to keep up to date regarding clinical trials that are currently recruiting may find the following informative. http://clinicaltrials.gov/ct2/show/NCT00801970?term=pregnancy&recr=Open This interventional study aims to identify the aetiology and essence of the fear of childbirth and to investigate the effectiveness of several forms of psychological therapy. Inclusion criteria: subjective diagnosis of tokophobia. Primary outcome measure: existing and new tokophobia measures, for example pregnancy anxiety scale. Secondary outcome measures: for pregnant subjects—labour preference, duration and pain medication assessment. Trial site: Tel Aviv, Israel. Anticipated trial end date: January 2011. This trial is interesting because the term, tokophobia, is so new. It was first used in 2000 to describe the dread that some women have of childbirth despite desperately wanting a baby (Br J Psychiatry 2000;176:83). In their study of 26 women, the authors concluded that phobic avoidance of pregnancy may date from adolescence (primary tokophobia), be secondary to a traumatic delivery (secondary tokophobia) or be a symptom of underlying depression. http://clinicaltrials.gov/ct2/show/NCT00809055?term=pregnancy&recr=Open This randomised, double-blind trial aims to determine why premature babies are more at risk of learning difficulties and movement disorders late on in childhood and the extent to which this is altered by standard or high-dose caffeine therapy. Brain development in the premature babies will be monitored by EEG) and magnetic resonance imaging (MRI). Inclusion criteria: preterm babies from 24 to 30 weeks admitted to the neonatal intensive care unit at St Louis Children’s Hospital; must be recruited within the first 24 hours of life. Primary outcome measures: length of time requiring mechanical ventilation; brain injury. Secondary outcome measures: mortality rates; length of time requiring any respiratory support; length of time after birth until resolution of apnoea of prematurity; rates of chronic lung disease; length of time requiring inotropic support; length of time after birth until full enteral feeds; rates of necrotising enterocolitis; infant neurobehavioral scoring by Dubowitz scale prior to discharge; evaluation of EEG seizure burden; rates of retinopathy of prematurity; advanced MRI by diffusion analysis and cortical folding measures; Bayley Scales of Infant Development scores at 2 and 4 years of age; rates of tachycardia and/or arrhythmias. Trial site: Missouri, USA. Anticipated trial end date: January 2015. This study aims to build upon the existing evidence that caffeine (methylxanthine) therapy for apnoea of prematurity improves the survival rate without neurodevelopmental disability (at 18–21 months) in infants with very low birthweight (N Engl J Med 2007;357:1893). In a randomised trial of 2006 infants with birthweights of 500–1250 g, treatment with caffeine compared with placebo reduced the incidence of cerebral palsy (4.4 versus 7.3%; adjusted OR 0.58; 95% CI 0.39–0.87; P = 0.009) and of cognitive delay (33.8 versus 38.3%; adjusted OR 0.81; 95% CI 0.66–0.99; P = 0.04). http://clinicaltrials.gov/ct2/show/NCT00803270?term=sexual+health&recr=Open This randomised trial aims to compare treatment outcomes for women with mixed urinary incontinence (MUI). Surgical versus nonsurgical treatments will be compared. Women will be randomly assigned to surgery for stress incontinence or to a nonsurgical approach, that is drug or behavioural therapy. Follow up will be 12 months. Inclusion criteria: female; MUI based on stress and urge symptoms reported using the MESA (Medical Epidemiologic and Social Aspects of Ageing) questionnaire; moderate or severe MUI; incontinence symptoms present for at least 3 months; bladder capacity >200 ml; Urodynamic Stress Incontinence; eligible for both treatment interventions; negative urine dipstick. Primary outcome measure: patient global impression index—improvement. Secondary outcome measures: Urogenital Distress Inventory; Incontinence Impact Questionnaire-7; Short Form-12; Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12; Bladder Diary; additional treatment; satisfaction with treatment outcome; economic and cost-utility measures; HUI3. Trial site: Various States, USA. Anticipated trial end date: August 2010. http://clinicaltrials.gov/ct2/show/NCT00807625?term=fertility+control&recr=Open Previous research has suggested that HIV progresses faster in women who use hormonal contraception than in those not using it. This randomised trial aims to improve our understanding of the mechanisms by which hormonal contraception may speed up the progression of HIV. Sixty-six women with HIV who require contraception will be randomly assigned to use either an IUCD or Depo Provera and will then be followed for 6 months. Inclusion criteria: confirmed HIV status by local rapid test algorithm; willingness to be randomised to a contraceptive method and continue that method for at least 6 months; intention to stay in the study area for at least 6 months. Primary outcome measure: T-cell activation. Secondary outcome measures: CD4+ cell decline; cervical viral load. Trial site: Lusaka, Zambia. Anticipated trial end date: July 2010. This trial is timely in the light of a recently published review of the literature assessing the effect of contraceptive choices on HIV risk and the course of disease in women with HIV (Hum Reprod Update 1 November 2008, Epub ahead of print). The best available evidence suggests that hormonal contraception may increase the risk of HIV acquisition in high-risk women, such as commercial sex workers, but not in women at low risk of HIV. While hormonal contraception did not affect progression of disease in two cohort studies, in a randomised trial among women not receiving antiretroviral medication, clinical disease accelerated in the oral contraceptive group compared with the copper IUCD group (hazard ratio 1.5; 95% CI 1.04–2.1). http://clinicaltrials.gov/ct2/show/NCT00803335?term=prolapse&recr=Open This randomised, single-blind trial aims to determine the length of time between application of hormonal vaginal cream and vaginal response in women with pelvic organ prolapse. The amount of cream to apply prior to vaginal repair of pelvic organ prolapse will also be assessed. Inclusion criteria: women aged 45 years or older; postmenopausal (>55 years if natural menopause); clinical atrophic vaginitis (at least mild atrophy); pelvic organ prolapse (at least stage II or greater); post hysterectomy; surgery date between 2 and 12 weeks after recruitment. Primary outcome measure: vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analysed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard haematoxylin and eosin stains. Secondary outcome measures: vaginal histology will be compared with validated pelvic floor quality-of-life questionnaires, vaginal health symptoms, vaginal health scoring and vaginal cytology. Trial site: Ohio, USA. Anticipated trial end date: June 2011. Highlighted during World Aids Day was the trend among governments worldwide to criminalise HIV transmission. It is reported that more than 58 countries around the world have laws that criminalise HIV transmission and a further 33 are contemplating introducing similar legislation. These laws, it is argued, increase exposure to violence because women usually know their status before their partners as a result of antenatal testing (in many regions partners are advised to be tested at this time, but generally only a minority agree). Additionally, criminalising HIV transmission may result in the prosecution of women in some countries for mother-to-child transmission. http://genderhealth.org/pubs/pr2008.www.wad.pdf