International guidelines/reports

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Community perceptions of prevention of mother-to-child transmission services and safe male circumcision in six focal states in Nigeria

This report, produced by the US Agency for International Development AIDS Support and Technical Assistance Resources (AIDSTAR-One) Project, presents the results of a qualitative study to understand community perceptions of services preventing mother-to-child transmission (PMTCT) of HIV services and of services providing safe male circumcision in six regions of Nigeria (Benue, Cross River, Sokoto, Bauchi, Lagos, Federal Capital Territory). There is strong cultural support to circumcise male children in Nigeria. Barriers to uptake of these services were identified, in particular in terms of male partner involvement in PMTCT services and the employment of traditional circumcisers (or Wanzamai) performing the circumcision in the home environment instead of a hospital setting in some of the regions studied. The report states that only 28% of women and 39% of men know that the risk of a mother transmitting HIV to her unborn child can be reduced by taking drugs during the antenatal period and the current uptake of PMTCT services reaches only 12% of women. The research is based on interviews with 50 health professionals, 35 focus group discussions, 17 interviews with traditional birth attendants and 12 HIV-positive women. The report aims to identify the most effective communication channels for reaching key audiences and will inform the development of behavioural changes and communication interventions to promote PMTCT and safe male circumcision to communities across Nigeria.

Women’s need for family planning in Arab countries

This policy brief, produced by the United Nations Population Fund (UNFPA), the Pan Arab Project for Family Health (PAPFAM) and the Population Reference Bureau, discusses the results of an investigation to determine the rate of unmet need for family planning by women in Arab countries. The briefing is based on national survey data collected by the PAPFAM over the past 10 years and the Demographic and Health Surveys. The briefing states that there is a growing need for family planning services in the Arab region as, according to the UNFPA, there has been an increase in the number of women of reproductive age (defined as women aged 15–49 years) from 69 million in 2000 to 93 million in 2012. Figure 1, in the policy brief, highlights the unmet need for family planning in Morocco, Palestine, Jordan, Egypt, Libya, Syria, Iraq and Yemen and Table 1 provides individual country data on fertility rate, percentage of women using any method of contraception, and the lifetime risk of maternal death. The causes underlying current unmet needs are explored and the briefing concludes by proposing a number of actions and interventions to address unmet needs.

Safe abortion: technical and policy guidance for health systems

The second edition of this technical and policy guidance document, published by the World Health Organization (WHO), provides evidence-based best practice guidelines for the provision of safe and comprehensive termination of pregnancy (TOP) services. The guidelines are aimed at programme managers, policy makers and health professionals providing TOP services. The guidance highlights that approximately 22 million TOPs are performed unsafely each year through which around 47 000 women die and about 5 million women suffer disability as a result of the procedure. Key recommendations are provided for pre-TOP clinical care, methods for both surgical and medical TOP both before and after 12 weeks of gestation and for the provision of care post-TOP as well as recommendations for health systems and regulatory, policy and human rights considerations. In addition, annex 1 highlights 15 specific knowledge gaps that have been identified by the guideline development group and annex 7 lists key international and regional human rights treaties.

Adolescent fertility in low-income and middle-income countries: effects and solutions

This working paper, produced by the Center for Global Development, presents an up-to-date review of the evidence regarding the socio-economic consequences of adolescent childbearing and of interventions to reduce adolescent fertility in low-income and middle-income countries. The working paper incorporates two reviews, one investigating how adolescent childbearing impacts on school continuation rates, human capital accumulation and productivity and the other on the effectiveness of interventions to reduce adolescent fertility. The working paper aims to inform programmes and policies, identify research gaps and contribute to new research agendas. A number of implications for practice and policy changes are outlined including improved matching of pregnancy interventions for adolescents according to the real causes of adolescent fertility within local contexts. The authors identified numerous gaps in the evidence and ten recommendations are provided for a revised research agenda: attempt to establish causality between adolescent fertility and socio-economic outcomes; understand the context of adolescent fertility; demonstrate external validity; expand outcomes; evaluate pregnancy and fertility; evaluate the effect of knowledge/attitude outcomes on overall fertility or pregnancy outcomes; include cost information; connect adolescent fertility and total fertility; continue evaluations for existing programmes; and evaluate the impact of generally unstudied interventions.

Clinical study recruitment

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

Internal mammary sentinel lymph node biopsy in early breast cancer patients with clinically axillary node-negative (IMSLNB-EBCP)

This phase III non-randomised study aims to investigate the modification of techniques for internal mammary sentinel lymph node (IMSLN) biopsy to improve visualisation rates. The modified techniques include injection of the radiotracer intraparenchymally into two to four quadrants of the breast and injection of the radiotracer in a high volume and under ultrasonographic guidance compared with the control group whereby the radiotracer is only injected into a single tumour quadrant of the breast without ultrasound guidance.

Inclusion criteria: Primary breast cancer; clinically axilla-negative.

Primary outcome measure: Visualisation rate of IMSLN.

Secondary outcome measures: Metastasis rate of IMSLN; frequency and severity of complications with IMSLN biopsy; success rate of IMSLN biopsy.

Study site: Shandong, China.

Anticipated study end date: December 2013.

Mobile phone technology for prevention of mother-to-child transmission of HIV: acceptability, effectiveness and cost

This cluster randomised controlled study involves 26 health facilities (randomised to either an intervention or a control arm) and aims to determine the effectiveness of mobile phone technology in the completion of prevention of mother-to-child transmission (PMTCT) of HIV interventions during the antenatal period and up to 6 weeks postpartum. The acceptability and cost of implementing PMTCT mHealth (mobile health) strategies will also be assessed.

Inclusion criteria: HIV-positive pregnant women seeking antenatal care at a study site; up to 32 weeks of gestation; own or have access to a mobile phone on which they can receive calls and short message service (SMS) messages.

Primary outcome measure: Proportion of women who successfully complete key PMTCT transition points from antenatal care to 6 weeks postpartum; initiation of infant prophylaxis, facility delivery and receipt of results of 6-week early infant diagnosis of HIV.

Secondary outcome measures: Uptake of antiretroviral (ARV) prophylaxis/antiretroviral therapy (ART) during labour, delivery and postpartum; self-reported maternal adherence to ARV prophylaxis/ART during pregnancy; time to initiation of ARV prophylaxis/ART uptake after initial antenatal identification of HIV seropositivity.

Study site: Nairobi, Kenya.

Anticipated study end date: April 2014.

Weekly Paclitaxel with or without Pazopanib in platinum-resistant or refractory ovarian cancer (MITO-11)

This randomised, multicentre, phase II trial aims to assess the safety and activity of the addition of pazopanib to weekly chemotherapy with paclitaxel in women with platinum-resistant or refractory ovarian cancer.

Inclusion criteria: Cytological/histological diagnosis of stage Ic–IV ovarian cancer; disease progressed during first-line chemotherapy or disease relapsed within 6 months after the last platinum treatment; disease evaluable by the Response Evaluation in Solid Tumours (RECIST) or CA125 Gynaecologic Cancer Intergroup (GCIG) criteria; no residual peripheral neurotoxicity from previous chemotherapy treatment; WHO Performance Status scales 0–1; aged at least 18 years and not older than 75 years; life expectancy of at least 3 months; able to swallow and retain oral medication; written informed consent before performance of study-specific procedures or assessments; ability and willingness to comply with treatment and follow-up assessments and procedures.

Primary outcome measure: Progression-free survival.

Secondary outcome measures: Number of women with objective response; worst grade toxicity per woman; overall survival.

Study site: Various locations, Italy.

Anticipated study end date: December 2014.

Technology-based community health nursing (TECH-N) to prevent recurrent sexually transmitted infections after pelvic inflammatory disease

This randomised study aims to assess the effectiveness of a repackaged version of the standard Centers for Disease Control and Prevention (CDC) follow-up visit, employing a technology-enhanced community health nursing intervention (TECH-N) and an evidence-based sexually transmitted infection prevention curriculum in young women aged between 13 and 21 years with pelvic inflammatory disease (PID). The investigators hypothesise that the addition of SMS communication support up to 30 days following the diagnosis of PID will improve adherence to PID treatment and therefore reduce short-term repeat infection and reduce rates of unprotected intercourse.

Inclusion criteria: Mild to moderate PID; outpatient treatment disposition; permanently reside in the Baltimore metropolitan area; willing to sign informed consent and to be randomised.

Primary outcome measure: Incidence of repeat sexually transmitted infections.

Secondary outcome measures: Adherence to self-treatment.

Study site: Maryland, USA.

Anticipated study end date: July 2017.

Treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy: the FEMME study

This multicentre randomised trial aims to compare the effectiveness of uterine artery embolisation (UAE) with myomectomy in women with symptomatic fibroids (who wish to retain their womb) in terms of quality of life post-surgery. The study will recruit 650 women from over 20 hospitals and a disease-specific questionnaire will be used to assess quality of life at 2 years post-surgery.

Inclusion criteria: Women with symptomatic fibroids who do not wish to have a hysterectomy; women considered suitable for either treatment (myomectomy or embolisation) and who have no strong preference for a particular treatment; clinical team uncertain as to which treatment is indicated; written informed consent; lower age limit 18 years.

Primary outcome measure: Change in the quality of life experienced by women after they undergo UAE or myomectomy (this will be reported after 2 and 4 years).

Secondary outcome measures: Changes in the level of ovarian hormones after UAE or myomectomy; changes in menstrual blood loss; number of adverse events; outcomes of any pregnancies that occur; resource use and re-intervention rates will be collected to determine the cost effectiveness of each procedure.

Study site: Various locations, UK.

Anticipated study end date: March 2014.

Patent news

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Patent applications

EP2472263 (A1) Methods for the prognostic assessment of breast cancer. This European patent application relates to the measurement of the level of expression of the protein kinase CK2+-subunit in breast cancer cells to determine the prognosis of women with breast cancer. Specifically, this patent involves obtaining a sample of breast cancer cells from the woman either during tumour resection or biopsy and analysing the sample for the level of expression of CK2α. A high CK2α expression is associated with poor prognosis.

Filhol-Cochet, O., Cochet, C., Charpin, C. Methods for the prognostic assessment of breast cancer. 4 July 2012.

US2012179225 (A1) Vaginal stimulator device and use thereof for the treatment of female urinary incontinence. This patent application relates to the invention of a vaginal stimulator device for the treatment of both female stress and urge urinary incontinence. The invention consists of a device that can be inserted into the vagina and that electrically stimulates the pelvic floor muscles.

This application claims benefit of US 61/229,886, filed 30 July 2009, the entire contents of which is incorporated herein by reference.

Guez, G. Vaginal stimulator device and use thereof for the treatment of female urinary incontinence. 12 July 2012.

US8211646 (B1) Methods of treating ovarian cancer by modulating SnoN. This US patent application outlines a method for treating cancer, in particular ovarian cancer, by modulating transforming growth factor (TGF-β) signalling pathway modulators such as Akt. Specifically, the cancer treatment discussed in the patent involves administering a first compound comprising at least one of arsenic trioxide, 17-allylaminogeldanamycin, TGF-β and a salt along with the administration of a second compound comprising of 3-methyladenine, bafilomycin A, c-Jun N-terminal protein kinase (JNK) II inhibitor, LY294002, triciribine, wortmanin, anti-Akt small interfering (si) RNA, dominant negative Akt, anti-Ski-related novel protein N (SnoN) siRNA, dominant negative SnoN, dominant negative DASCH1, dominant negative multidrug resistance protein 1 (MRP1), anti-MRP1 siRNA, TGF-βRII, anti-glutathione (GSH) siRNA, or dominant negative GSH.

This application claims priority to pending US Provisional Patent Application No. 61/114,728, entitled ‘Overexpression of SnoN/SkiL, Amplified at the 3Q26.2 Locus, In Ovarian Cancers: A Role in Ovarian Pathogenesis’, filed on 14 November 2008, the contents of which are herein incorporated by reference.

Nanjundan, M., Mills, G., Smith, D. Methods of treating ovarian cancer by modulating SnoN. 3 July 2012.

Legal matters

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France donor anonymity holds firm in court case

A French Court has recently reasserted French laws regarding gamete donor anonymity. Invoking Article 8 of the European Convention on Human Rights, a donor-conceived woman claimed that she was entitled to information about her biological father because it was necessary for her mental health. Although requesting non-identifying information, the woman’s claim was rejected on the grounds that any information provided by gamete donors to fertility clinics in France is protected under French law. In cases of medical necessity French law does permit donor anonymity being lifted but the court did not believe that this case met the criteria for ‘medical necessity’.

  1. Shona Kirtley, Research Information Specialist, Centre for Statistics in Medicine, University of Oxford, UK and Patrick Chien, Consultant Obstetrician and Gynaecologist, Ninewells Hospital, Dundee, UK.