Women's health—what's new worldwide

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International guidelines/reports

Interventions to reduce the prevalence of female genital mutilation/cutting in African countries

This review, prepared by the International Initiative for Impact Evaluation (3ie), adopts a realist synthesis approach that integrates the effectiveness data of interventions to reduce the prevalence of female genital mutilation/cutting (FGM/C) when compared with either no or another active intervention with context data on how factors related to the continuation or discontinuation of FGM/C help to explain the effectiveness of FGM/C interventions. The data were derived from a rigorously conducted systematic review of the available literature.

Overall the study looked at 7042 participants from nine African countries. Eight effectiveness and 27 context studies were idenitfied for the review. FGM/C is reported to be practiced in around 28 African countries. The prevalence of FGM/C in certain countries is around 70%, although there is considerable variation both within and between countries. The interventions assessed include training and education (including the Tostan education programme), outreach and advocacy and multimedia communication. The synthesis of context studies showed that the factors related to the continuance and discontinuance of FGM/C varied across contexts, but the main factors that supported FGM/C were tradition, religion and reduction of women's sexual desire. The main factors that hindered FGM/C were medical complications and prevention of sexual satisfaction. The extent to which a conclusion could be drawn, on how the factors related to the continuance and discontinuance of FGM/C can help to explain the effectiveness of interventions, was limited. However, the effectiveness of any intervention was dependent on the successful dissemination of information about FGM/C, and a range of contextual factors. For example, where FGM/C and Islam were closely related, failure to involve religious leaders and ensuring that the programme had considered the benefits for the community tended to correlate with a lower attendance and higher programme drop-out rate. Recommendations include: the need to establish community-approved, nonsectarian, politically and culturally acceptable organisations to work towards the abandonment of FGM/C; programme managers must gain the support of local community decision makers and ensure that interventions are culturally responsive; the need to conduct well-designed and methodologically sound evaluations of interventions, ensure long-term measurement of outcomes and in particular address local community enforcement systems that support FGM/C and be based upon key behaviour change theories.

www.3ieimpact.org/media/filer/2013/02/06/sr009_fgm_bergdenison.pdf

Toolkit on how to protect and promote the nutrition of mothers and children

This web-based toolkit published by the World Bank has been specifically designed to help countries in Latin America and the Caribbean—which tend to be affected recurrently by a range of crises, including social and economic upheavals, periods of major food price volatility and devastating natural disasters—devise and introduce policies to address the nutritional needs of mothers and young children in response to both stable and unstable circumstances. Aimed at non-specialists in nutrition such as crisis response teams, programme managers and policy makers, the toolkit comprises three main sections: policy guidance; country benchmarking; and case studies. The policy guidance section includes comprehensive information on prioritising nutrition interventions and cross-cutting approaches to address the issue. Specific advice is provided for maternal and infant nutrition. The benchmarking section provides data from 12 countries from the Latin American and Caribbean region and includes information on infant feeding practices, micronutrient deficiencies, and the availability of complementary food products. The case studies section provides valuable information about how four different countries have, in practice, responded to different unstable situations and successfully implemented the recommended interventions. A comprehensive list of links to additional resources for individual countries is also provided.

http://web.worldbank.org/WBSITE/EXTERNAL/COUNTRIES/LACEXT/EXTLACREGTOPHEANUTPOP/EXTLACREGTOPNUT/0,,contentMDK:23342299~pagePK:34004173~piPK:34003707~theSitePK:4160378,00.html

Comprehensive cervical cancer prevention and control: a healthier future for girls and women

This World Health Organization (WHO) guidance, aimed at programme managers and senior policy makers, provides a vision of what comprehensive cervical cancer control and prevention is, how complementary strategies might work in the primary, secondary and tertiary prevention of cervical cancer and discusses the need for collaborative working between partners, programmes and organisations. On a worldwide basis, cervical cancer is the second most common cancer and of the 270 000 women that die every year from it, 85% of these deaths are from low-income and middle-income countries. Primary prevention involves the employment of human papillomavirus (HPV) vaccination targeted at girls aged between 9 and 13 years, who are generally not yet sexually active. For both girls and boys, as appropriate, health information and warnings about tobacco use, sexuality education tailored to age and culture, condom promotion/provision for those engaged in sexual activity and male circumcision are the other recommended primary preventive measures. Secondary prevention aims at the early detection and treatment of precancerous lesions using conventional (Papanicolaou smear) and liquid-based cytology, visual inspection with acetic acid and HPV testing for women aged between 30 and 49 years old. At a minimum, screening is recommended for every woman within this age group at least once in a life time. Tertiary prevention addresses the treatment and palliative care for cervical cancer. The challenges here are the establishment and maintenance of treatment referral networks, compliance with treatment, and effective palliative care. A helpful checklist is included for establishing a comprehensive cervical cancer prevention and control programme.

http://apps.who.int/iris/bitstream/10665/78128/3/9789241505147_eng.pdf

WHO Global Health Equity Monitor

The WHO Global Health Observatory Health Equity Monitor has recently been published online. The Health Equity Monitor database currently includes around 30 reproductive, maternal, neonatal and child health indicators covering 91 different countries with data gathered from around 200 Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS) conducted between the years 1993 and 2011. Data are available for at least two time points during these years for around half of the included countries and the data, arranged by place of residence, educational level or wealth quintile, include contraceptive prevalence, family planning needs, antenatal care coverage, births attended by skilled health professional, births by caesarean section, pregnant women sleeping under insecticide-treated nets and postnatal care visit. Additional filters can also be applied when accessing the database such as data source, year and WHO region. Detailed country profiles and interactive visualisations showing inequalities in selected health outcomes and services are also provided. The Health Equity Monitor database aims to provide an evidence database for equity-oriented interventions and contribute towards the goal of universally equitable health coverage.

http://apps.who.int/gho/data/node.main.HE-1540

Patent news

Patent applications

WO2013033607 (A1) Improved vaginal speculum

This world patent application relates to the invention of a radially expanding vaginal speculum. Specifically, the design of this speculum allows for it to be expanded in more than one dimension allowing for better visualisation of the cervix and therefore enhanced cervical inspection and procedures.

Bouquet, J. 7 March 2013.

http://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=17&ND=3&adjacent=true&locale=en_EP&FT=D&date=20130307&CC=WO&NR=2013033607A1&KC=A1

AU2011295013 (A1) Means and methods for the detection of a predisposition of a female subject to recurrent pregnancy loss (RPL), preeclampsia (PE) and/or fetal growth restriction (FGR)

This patent application proposes a method of diagnosing or detecting a woman's predisposition to experiencing recurrent pregnancy loss (RPL), pre-eclampsia (PE) and/or fetal growth restriction (FGR). Specifically, this method involves the examination of human annexin A5 (ANXA5) promoter contained in a sample obtained from the biological father to detect nucleotide exchanges. The presence of nucleotide exchanges is said to indicate a predisposition for the woman to experience RPL, PE or FGR. Details of a diagnostic kit are also outlined.

Markov, A., Bogdanova, N., Gerke, V. 14 March 2013.

http://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20130314&CC=AU&NR=2011295013A1&KC=A1

US2013066302 (A1) Intrauterine elec-tronic capsule for administering a substance

This patent application relates to the invention of an electronic capsule that can be placed within a reproductive organ such as the cervix or uterus and can then locally dispense substances such as fertility drugs, hormonal drugs or semen. The capsule can be fitted with a wireless communication connected to an external processor and be controlled by a clinician to allow for accurate control over the timing and dosage of the substance being administered.

Weiner, O.H., Shimizu, J., Zou, H., Iordanov, V.P., Dijksman, J.F. 14 March 2013.

http://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=10&ND=3&adjacent=true&locale=en_EP&FT=D&date=20130314&CC=US&NR=2013066302A1&KC=A1

WO2013033933 (A1) Kit, process and use for measuring and evaluating sensitivity of ovarian cancer to primary chemotherapy

This patent application outlines methods and a kit for measuring and evaluating the sensitivity of ovarian cancer to primary chemotherapy. Specifically, the invention involves determining the expression level of ERCC2, which correlates with whether the cells, tissues or tumour will respond to primary chemotherapy treatment.

Cui, S., Ding, Y., Zhao, J., Yang, L., Bi, L., Jiang, J. 14 March 2013.

http://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=14&ND=3&adjacent=true&locale=en_EP&FT=D&date=20130314&CC=WO&NR=2013033933A1&KC=A1

Legal matters

Ireland: genetic mother wins surrogacy case

In a landmark case, the Irish High Court has recently ruled that a woman who is the biological mother of twins born via a surrogate can be officially recognised as the legal mother of both children. The twins were conceived using the woman's egg and her husband's sperm and since birth have lived with their genetic parents. The genetic parents attempted to have the twins’ birth certificates corrected in 2010 to list the genetic mother as the twins’ legal mother. When this was refused, legal action was pursued. The Irish Government had argued that the Irish Constitution defines the birth mother as the ‘mother’ and that this could not be altered. It said that the maxim ‘motherhood is always certain’ applied in this case. Despite this ruling, the Irish Government has 21 days to appeal this decision to the Supreme Court, and this appears to be likely. There is currently no legislation in Ireland regarding surrogacy and, according to the Irish Constitution, only the ‘birth’ mother can be registered as the legal ‘mother’. It is hoped that as a result of this landmark ruling legislation regarding surrogacy will be enacted.

www.bionews.org.uk/page_265258.asp

Clinical study recruitment

Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.

Preoperative bowel preparation prior to minimally invasive sacral colpopexy
Registration www.clinicaltrials.gov/ct2/show/NCT01805310
Description This phase 4 randomised trial aims to establish whether bowel preparation with 300 ml magnesium citrate administered orally with clear liquid diet on the day before women undergo minimally invasive sacral colpopexy compared with no bowel preparation with normal diet affect the likelihood of operative or postoperative complications, postoperative recovery (specifically related to bowel function), the perceptions of surgeons regarding the ease of bowel manipulation and pelvic visualisation during surgery.
Outcome measures Primary: Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM).Secondary: Surgeon perception of bowel preparation; return of normal bowel function; perioperative complications.
Study site Pennsylvania, USA.Anticipated study end date: June 2014.
The effect of laparoscopic ovarian cystectomy of endometrioma versus cyst deroofing on ovarian reserve as determined by anti-müllerian hormone and antral follicle count
Registration www.clinicaltrials.gov/ct2/show/NCT01808170
Description This randomised study aims to assess the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve in women with endometriomas. In all, 122 women will be recruited and ovarian reserve postoperatively will be measured by serum levels of anti-müllerian hormone (AMH) and antral follicle count.
Outcome measures Primary: Postoperative ovarian reserve as determined by serum AMH level.Secondary: Postoperative ovarian reserve determined by antral follicle count estimation and ovarian volume measurement by ultrasound.
Study site Cairo, Egypt.Anticipated study end date: September 2013.
Intraperitoneal aerosol high-pressure chemotherapy for women with recurrent ovarian cancer
Registration www.clinicaltrials.gov/ct2/show/NCT01809379
Description This phase 2 observational study on 50 women with recurrent ovarian cancer aims to investigate the feasibility, efficacy and safety of pressurised intraperitoneal aerosol chemotherapy (PIPAC) using cisplatin at a dose of 7.5 mg/m2 body surface in 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.
Outcome measures Primary: Clinical benefit rate defined by complete remission, partial remission, and stable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.Secondary: Safety defined by left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy. Complications postoperative until hospital discharge, re-admission to hospital, death.Other: Tumour apoptosis assessment, videolaparoscopy assessment of response, CA125 at 6 months post-treatment.
Study site Bochum, Germany.Anticipated study end date: February 2014.
Misoprostol administration before operative hysteroscopy
Registration www.clinicaltrials.gov/ct2/show/NCT01805115
Description This phase 3 randomised double-blind study aims to compare the efficacy, in premenopausal women undergoing operative hysteroscopy, of previous self-administration of oral misoprostol, sublingual misoprostol, vaginal misoprostol (400 μg 8–12 hours before hysteroscopy for either the oral, sublingual or vaginal routes) or no misoprostol on the prehysteroscopy diameter of the cervical canal determined by the diameter of the largest Hegar dilator that can be inserted through the internal cervical os without encountering any resistance.
Outcome measures Primary: Prehysteroscopy diameter of the cervical canal.Secondary: Misoprostol-associated side effects.
Study site Seoul, Korea.Anticipated study end date: July 2014.

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