SEARCH

SEARCH BY CITATION

International guidelines/reports

  1. Top of page
  2. International guidelines/reports
  3. Clinical study recruitment
  4. Patent news
  5. Legal matters

MDG Report 2012 Assessing Progress in Africa toward the Millennium Development Goals: emerging perspectives from Africa on the post-2015 development agenda

This report produced by the United Nations Development Programme-Regional Bureau for Africa (UNDP-RBA), the African Union Commission (AUC), the United Nations Economic Commission for Africa (UNECA) and the African Development Bank (AfDB) is based on the latest data from the United Nations Statistics Division. The report states that despite stable economic growth and improvements in poverty reduction, which have had a positive impact on progress towards the Millennium Development Goals (MDGs), there is still much to be done across the African continent. Areas that still need to be addressed include: inequalities between men and women; poor quality and unequal access to social services; and ensuring that economic growth is translated into employment opportunities. Comprehensive information is provided on progress towards achieving MDG 3, which aims to improve gender equality and empower women. The report states that progress is being made but that promoting paid employment for women (apart from agricultural jobs) remains a challenge. MDG 5, improving maternal health, remains a huge challenge for Africa with an average maternal mortality ratio of 590 deaths per 100 000 live births in 2008. No new comprehensive data for maternal health indicators has been compiled since 2008. This has impacted upon assessments of the effectiveness of interventions and therefore on decisions regarding which programmes or interventions should be funded. The path to MDG 5 is clear, but Africa lacks the roadway to reach the destination of lowering maternal mortality. To do so it will require universal access to safe abdominal delivery for any mother in need. Delivering a surgical intervention in developing countries with numerous cultural, logistical and educational barriers is a complex challenge. Perhaps the fruit of empowering women within MDG 3 will emerge over time, with indigenous solutions to this shameful problem, as women learn that mothers do not have to die during childbirth. It is now likely that Africa will achieve the MDG targets of: universal primary education; gender parity at all levels of education; decreased prevalence of HIV/AIDS among 15–24-year-olds; increased proportion of the population with access to antiretroviral drugs; and increased proportion of women holding seats within national parliaments. The report highlights the issue of the MDGs post-2015 and states that priorities set for beyond 2015 must take into account Africa’s experiences and lessons learnt from the current MDG targets and that ‘ultimately African countries will have to transform their economies in ways that not only support rapid and inclusive growth but also generate enough domestic resources to offset shortfalls in external funding’.

Good practices in essential supplies for family planning and maternal health

This United Nations Population Fund (UNFPA) report provides individual country activity information from countries participating in the Global Programme to Enhance Reproductive Health Commodity Security (GPRHCS), which was launched by the UNFPA in 2007. The GPRHCS was established to provide a structure for planning and delivering sustainable family planning services, procuring and securing essential supplies and ensuring their uptake at individual country levels. Overall, 46 countries are involved in the Global Programme and this report includes examples of activities from Burkino Faso, Madagascar, Sierra Leone, Ecuador, Mozambique, Ethiopia, Niger, Mongolia, Nicaragua, Senegal and Lao People’s Democratic Republic (Lao PDR). Table 1 includes examples of such activities.

Table 1.   Examples of activities in certain countries participating in the GPRHCS
CountryActivity
Lao PDRAgents visit households once a month to promote services and provide counselling
Burkino FasoCommunity theatre, TV and radio are all used to raise awareness of reproductive health issues
Sierra LeoneSociety organisations monitor essential supplies of family planning materials to ensure accountability and access
NicaraguaInstitutionalising reproductive health indicators has encouraged political and financial commitments for increased reproductive health commodities access
NigerSchools for husbands have been established to involve men in reproductive health and family planning
MongoliaPharmacy curricula now teach students how to avoid shortages in the availability of essential family planning supplies
MozambiqueWomen and girls (between the ages of 12 and 35 years) meet for 2 hours each week to discuss sexual and reproductive health issues
MadagascarThe government is strengthening systems to ensure secure supplies and effective management of reproductive health commodities
SenegalCommunity leaders promote good maternal and newborn health practices to the young women in their villages
EcuadorSupport from the President and national government ensures the procurement of modern family planning methods
EthiopiaReproductive health commodity training has been built into the curricula of public health and pharmacy schools

The report states that around 222 million women living in low-resource settings would like to use some form of contraception but do not have access to family planning services.

Copenhagen Consensus 2012 Challenge Paper: infectious disease, injury and reproductive health

This challenge paper prepared by the Copenhagen Consensus 2012 is based on the results of the Disease Control Priorities Project (DCPP), which involved over 350 authors estimating the cost-effectiveness of 315 different interventions. The DCPP aims to combine the estimates (some of which highlighted that an intervention was a low priority or that the intervention only addressed a small proportion of disease burden) provided by the authors with research results and operational experience. This particular paper focuses on six key intervention solutions and provides a cost–benefit analysis for each: tuberculosis treatment; malaria (support for Affordable Medicines Facility—malaria); childhood immunisation; HIV accelerated vaccine development; essential surgery; and de-worming school children. Section 4 of the paper discusses in detail current reproductive and child health problems and opportunities in delivering health interventions and section 5 focuses on the prevention of HIV and on AIDS vaccine development.

Cervical cancer prevention course

This online cervical cancer prevention international programme is supported by International Federation of Obstetrics and Gynecology, World Health Organization, International Atomic Energy Agency, Elsevier, Union for International Cancer Control and International Agency for Research on Cancer. The course, which is aimed at health professionals, health planners, managers and researchers, provides an in-depth overview of the epidemiology of cervical cancer, the progress that has been made in the prevention of human papillomavirus infection (HPV) and cervical cancer and the latest scientific advances. Course objectives include: understanding the natural history of HPV and cervical cancer and the role of HPV infection in cervical carcinogenesis; ability to define the role of co-factors in the persistence of HPV infection and the progression of precancerous lesions to invasive cervical cancer; identification of the global impact of cervical cancer and assessment of different regional incidence and mortality rates across the world; recognition of the impact of HPV infection on other types of cancer and benign disease; familiarity with the range of different HPV vaccines available, their effectiveness and safety profiles and awareness of the factors to be considered when introducing vaccination; awareness and understanding of other primary prevention methods for HPV infection; ability to identify and understand the advantages and disadvantages of different cervical screening methods; recognition of the impact of HPV infection in specific populations such as during pregnancy. The course, which is estimated to take around 15 hours to complete, consists of six modules and the final evaluation involves an online assessment of 30 multiple-choice questions. The course is freely available and once registered participants are permitted 4 weeks to complete the course. We are experiencing a biological revolution in cervical cancer prevention with new abilities to detect high risk viruses and vaccinate against them. This course will keep clinicians up to date.

Clinical study recruitment

  1. Top of page
  2. International guidelines/reports
  3. Clinical study recruitment
  4. Patent news
  5. Legal matters

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

Postpartum etonogestrel implant for adolescents (PPImplant)

This phase IV prospective randomised controlled trial aims to compare the effectiveness in young women of an etonogestrel-releasing subdermal contraceptive implant inserted postpartum before discharge with usual care involving the insertion of an etonogestrel-releasing subdermal contraceptive implant at the 6-week postpartum clinic visit. Women will be followed up at 3, 6, 9 and 12 months after implant insertion.

Inclusion criteria: Adolescents aged 14–24 years attending prenatal care; >20 weeks estimated gestation; English-speaking or Spanish-speaking; desire to use the contraceptive implant for contraception postpartum; anticipated delivery of a healthy infant vaginally or by caesarean.

Primary outcome measure: Continuation at 1 year.

Secondary outcome measures: Satisfaction; rapid repeat pregnancy.

Study site: North Carolina, USA.

Anticipated study end date: February 2014.

Availability and effect of postoperative ketorolac on ovarian, fallopian tube or primary peritoneal cancer

This pilot trial aims to evaluate, in women undergoing surgery for ovarian, fallopian tube or primary peritoneal cancer, the anti-cancer effect of a pain medication called ketorolac (Toradol) on ovarian cells within the peritoneal cavity. The investigators hypothesise that ketorolac inhibits gene activity, which could inhibit cell adhesion and migration in ovarian cancer cells.

Inclusion criteria: Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery; borderline ovarian cancer with ascites; Eastern Cooperative Oncology Group (ECOG)/Zubrod/Southwest Oncology Group (SWOG) performance status <2 (Karnofsky performance status ≥70%); ability to provide informed consent; absolute neutrophil count >1000/μl; platelet count >100 000/μl; serum creatinine ≤1.5 times the upper limit of normal (ULN); bilirubin ≤1.5 times normal; serum glutamic oxaloacetic transaminase (SGOT) [aspartate aminotransferase (AST)] or serum glutamic pyruvic transaminase (SGPT) [alanine aminotransferase (ALT)] levels ≤2 times ULN; no known bleeding disorders; no known sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs); no active peptic ulcer disease; no active bleeding.

Primary outcome measure: Measure levels of ketorolac in peritoneal cavity.

Secondary outcome measures: Measure effect of intravenous ketorolac on ovarian cancer cell adhesion and migration.

Study site: New Mexico, USA.

Anticipated study end date: March 2016.

Placental growth and adverse pregnancy outcomes

This study aims to establish whether measuring maternal serum biomarkers and ultrasound evaluation of the placenta can improve prediction of adverse pregnancy outcomes. Placental volume and diameter will be measured at 11–14 weeks and at 18–24 weeks.

Inclusion criteria: All singleton gestations presenting for sequential screen testing at the Hospital of the University of Pennsylvania; women competent to provide verbal informed consent.

Primary outcome measure: Small for gestational birth weight (SGA-dichotomous).

Secondary outcome measures: Composite adverse outcome defined by any of SGA, pre-eclampsia, or perinatal death.

Study site: Pennsylvania, USA.

Anticipated study end date: September 2013.

Ondansetron versus doxylamine and pyridoxine in treating nausea of pregnancy

This study aims to determine whether the efficacy of ondansetron is equivalent to the efficacy of combined pyridoxine and doxylamine in treating nausea and vomiting of pregnancy. Women will be randomised to receive either ondansetron 4 mg plus a placebo capsule to be taken orally every 8 hours for 5 days or to pyridoxine 25 mg and doxylamine 12.5 mg to be taken orally every 8 hours for 5 days.

Inclusion criteria: Women who are <16 weeks pregnant by last menstrual period or ultrasound; >18 years of age; English-speaking; no significant visual or hearing impairment; requesting treatment for nausea associated with pregnancy.

Primary outcome measure: Reduction of nausea on the Visual Analogue Scale (VAS).

Secondary outcome measures: Reduction in vomiting on the VAS; any adverse effects caused by the study medications.

Study site: California, USA.

Anticipated study end date: January 2013.

Patent news

  1. Top of page
  2. International guidelines/reports
  3. Clinical study recruitment
  4. Patent news
  5. Legal matters

Granted patents

US 8236848 Diindolylmethane for the treatment of HPV infection.  This US-granted patent outlines methods and compositions comprising diindolylmethane to treat common skin warts and human papillomavirus-related conditions affecting the oropharynx, larynx, genitalia and uterine cervix. Diindolylmethane is a phytochemical found in cruciferous vegetables and the patent discusses the use of both diindolylmethane used alone and in combination with immune potentiating steroids.

Zeligs, M. A. Diindolylmethane for the treatment of HPV infection. 7 August 2012.

Patent applications

US 2012/0195942 A1 Dosage forms of active ingredients containing hydroxystilbene for treating menopausal complaints.  This US patent application proposes processes and dosage forms for the use of hydroxystilbene in the treatment of menopausal symptoms, oligomenorrhoea and dysmenorrhoea in young women and primary and secondary amenorrhoea or endometritis. Specifically, the patent claims that solid, semisolid and liquid dosage forms of ERr 731® and other active ingredient combinations can be produced without the coating containing plasticiser, so reducing possible adverse effects.

This application is a continuation of US application Ser. No. 11/883667, Allowed, which is the US national phase application, pursuant to 35 USC §371, of PCT international application Ser. No. PCT/EP2006/000957, filed 3 February 2006, designating the USA and published in German on 10 August 2006 as publication WO 2006/082073 A1, which claims priority to German application Ser. Nos. DE 10 2005 005 268.1, filed 4 February 2005 and DE 10 2005 005 271.1, filed 4 February 2005. The entire contents of the aforementioned patent applications are incorporated herein by this reference.

Heger P, Rettenberger R, Spaich C-F. Dosage forms of active ingredients containing hydroxystilbene for treating menopausal complaints. 2 August 2012.

US 2012/0196316 A1 Analysis of ova or embryos with digital holographic imaging.  This US patent relates to a method for analysing a sample containing at least one ovum or embryo using digital holographic imaging. Specifically, the invention aims to allow for the analysis and classification of an ovum or embryo without the requirement for a judgement from an individual (which is dependent on skill and experience) and for this to be achieved using relatively inexpensive equipment (only one imaging technology compared with the complicated and expensive equipment necessary for OQM).

Sebesta M, Persson J, Gisselsson L, Mölder A, Längberg A. Analysis of ova or embryos with digital holographic imaging. 2 August 2012.

Legal matters

  1. Top of page
  2. International guidelines/reports
  3. Clinical study recruitment
  4. Patent news
  5. Legal matters

Rwandan government takes critical step in recognising women’s fundamental human rights

The Rwandan government has recently lifted its reservation to Article 14(2)(c) of the African Charter on Human and People’s Rights of Women in Africa (Maputo Protocol) after ratifying a new law within the Rwandan penal code reducing the criminal penalties that women face when terminating a pregnancy and also those penalties faced by doctors who offer termination of pregnancy services. This revision, however, still requires women to obtain written approval from a court first before seeking a termination of pregnancy if the pregnancy is a result of rape, incest or forced marriage.

Footnotes
  1. Shona Kirtley, Research Information Specialist, Centre for Statistics in Medicine, University of Oxford, UK and John Thorp, North Carolina Center for Women’s Health Research, USA.