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International guidelines/reports

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  2. International guidelines/reports
  3. Clinical trial recruitment
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Encouraging women to use professional care at childbirth: does Nepal’s Safe Delivery Incentive Programme work

This briefing article reports on a financing scheme introduced in Nepal in 2005. The Safe Delivery Incentive Programme (SDIP) aims to increase use of maternity services by providing cash to women who attend a health facility during delivery and also by providing an incentive to midwives who attend women during childbirth. It is a fascinating report and while it demonstrates improvements in the use of professional care during childbirth, it also illustrates that the cash incentive generally covers only a quarter of the cost of a normal delivery and 1/20th of the cost of a caesarean section, resulting in financial hardship for some. The SDIP is the first programme to be introduced nationally in a low income country. The findings of this report, therefore, may have implications for other developing countries considering a similar approach to encourage women to seek professional care during childbirth. This programme is part of a 5-year maternal and newborn health research programme called Towards 4 + 5 funded by the Department for International Development, (DFID) UK.

Genetics and genetic testing––patient information leaflets

These patient information leaflets, developed by EuroGentest, have been designed to provide scientific, social and psychological information about genetics and genetic testing to patients and their families. The leaflets are well laid out and provide detailed information about genetic testing, risks and reliability in a simple way. Topics include: amniocentesis; chromosome translocations; CVS; dominant inheritance and x linked inheritance. The leaflets are freely available in 20 different European and ethnic minority languages.

Global action for health system strengthening: policy recommendations to the G8

This report, by the Task Force on Global Action for Health System Strengthening, has been prepared as a result of recommendations from the 2008 G8 summit in Japan. The report documents policy recommendations for all G8 countries regarding the creation of a global strategic framework for strengthening health systems in developing countries. The report covers four main areas: the G8 and global health; opportunities for overcoming the health workforce crisis; strengthening health financing in partner developing countries and toward collective action in health information.

The economics of sexual and reproductive health: resources for training sexual and reproductive health professionals in economic analysis

This training resource book, published by the Royal Tropical Institute in the Netherlands and the United Nations Population Fund (UNFPA), aims to help sexual and reproductive health managers and technical staff to run better and more sustainable programmes by ensuring that they understand basic concepts and tools for economic analysis. The resource book has been developed as a series of individual booklets and is designed to be delivered during a number of short training sessions. This book is aimed at people with little or no prior knowledge of economic analysis. Topics covered include: cost and expenditure analysis; using economic analysis to justify public intervention for sexual and reproductive health; economic approaches to equity; the economic impact of sexual and reproductive health and estimating future financial resource needs.

Compernolle P, Vassall A, Baltussen R, Jansen E, Weismann E. (2008) The economics of sexual and reproductive health: resources for training sexual and reproductive health professionals in economic analysis. Amsterdam KIT and UNFPA.

Clinical trial recruitment

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  3. Clinical trial recruitment
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Clinicians keen to keep up-to-date regarding clinical trials that are currently recruiting may find the following informative.

A phase 1 study of the safety and pharmacokinetics of AGS-8M4 in subjects with advanced ovarian cancer

This trial aims to assess the safety and pharmacokinetics of a potential new immune treatment, AGS-8M4, in treating advanced ovarian cancer. AGS-8M4 is an antibody that targets a protein AGS-8 associated with approximately 70% of ovarian cancer cells. There will be four dose cohorts into which patients will be enrolled sequentially. AGS-8M4 will be given to patients as an IV infusion every 2 weeks. Assessment will take place in week 9 with a safety follow-up 4 weeks after treatment has finished.

Inclusion criteria: subjects with recurrent disease or a confirmed stage III/IV diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma; subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or non-measurable disease after first line therapy) or progressive disease at anytime.

Trial site: New York, USA.

Ultrasound study in pregnant women with malaria (UPS)

This observational study aims to recruit 400 women over a 2-year period to investigate the effect of malaria on fetal growth. It is recognised that malaria causes IUGR and low birthweight, but little is known about the impact of the timing of infection during pregnancy on birthweight. Women will be screened before 13 + 6 weeks and will then have regular ultrasound scans throughout pregnancy in keeping with the INTERGROWTH-21st protocol (http://www.medscinet.net/intergrowth/). If a woman becomes infected with malaria, extra scans will be performed to measure placental blood flow. Blood samples will be taken from all women, as well as placental and cord samples at delivery.

Inclusion criteria: singleton viable pregnancy;age ≥18 years old; Gestational age between 9 + 0 and 13 + 6 weeks by ultrasound (CRL); able to communicate in Burmese, Karen or English language.

Primary outcome measure: ultrasound measurements.

Secondary outcome measures: examination of all newborns.

Trial site: Tak, Thailand.

Anticipated trial end date: December 2012.

Ovarian hyperstimulation syndrome (OHSS) prevention with agonist

This study aims to investigate, in women undergoing IVF who are at risk of OHSS, the effectiveness and safety of ‘triggering’ final oocyte maturation with a GnRH-agonist (instead of hCG). GnRH agonist triggering is associated with a lower incidence of OHSS than when hCG is administered, but pregnancy rates are not as high (perhaps because of a defective luteal phase). In an attempt to overcome this, embryos can be electively cryopreserved by vitrification and then replaced in a thawed embryo transfer cycle (see Griesinger et al., Hum Reprod 2007;22:1348–52 for a proof of concept study).

Inclusion criteria: Indication for IVF with ICSI; age <40; <4 failed previous IVF attempts with embryo transfer; ovarian stimulation with GnRH-antagonist and gonadotrophins; >20 follicles >11 mm in mean diameter or E2 > 4500 pg/ml on the day planned for hCG administration; willing to participate and able to consent; patient has not previously received GnRH-agonist as a trigger.

Primary outcome measure: cumulative continuing pregnancy rate per patient within 12 months.

Secondary outcome measures: continuing pregnancy rate/frozen-thawed ET; continuing pregnancy rate/first frozen-thawed ET; time to pregnancy in weeks; incidence of OHSS; number of cumulus-oocyte-complexes; fertilisation rate (number COCs/number of 2 [pronucleate] PN oocytes); survival rate (number of vital embryos/number of frozen 2 PN oocytes).

Trial site: Various, Germany.

Anticipated trial end date: July 2010.

Comparison of two internet supported natural family planning methods

This interventional study aims to compare the effectiveness of two internet-based natural family planning (NFP) methods. One uses a hand-held electronic hormonal fertility monitor that measures urinary estrogen and LH and the other involves self-observation of cervical mucus. An online charting facility will be used to record information and will also automatically calculate the days of high and low fertility. The influence of motivation by both partners to follow these NFP methods will also be assessed. A small retrospective study by this team showed that the electronic hormonal fertility monitor was 99.4% effective when used correctly; however, in all users, it was only 89.4% effective (Fehring et al., MCN Am J Matern Child Nurs 2008;33:348–54).

Inclusion criteria: Age 18–42; in a sexually active committed relationship with a man; 21–42 day menstrual cycle range.

Primary outcome measure: unintended pregnancy.

Secondary outcome measures: user satisfaction; ease of use; mutual motivation.

Trial site: Wisconsin, US.

Anticipated trial end date: December 2011.

Patent news

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Granted patents

US 7482029 Composition for treatment of menopause.

A patent has been granted for a herbal preparation to treat menopausal symptoms, particularly hot flushes. It consists of a mixture of herbs, including Herba Scutellaria barbata, Radix Sophora subprostratae, Radix Anemarrhena, Semen Glycine sojae, Radix Glycyrrhiza, Rhizoma Rhei, Fructus Tritici levis and many others. The preparation, when administered in sufficient quantities, activates the estrogen response element through the β-estrogen receptor (ER) and should reduce the severity and frequency of menopausal symptoms. The composition does not activate the α-ER, stimulation of which is associated with adverse effects in rodents (Hewitt SC, Korach KS. Estrogen receptor knockout mice: roles for estrogen receptors alpha and beta in reproductive tissues. Reprod 2003;125:143–9). Therefore, it is assumed that stimulation of the β-ER alone should avoid the adverse effects of estrogen therapy such as the increased risk of breast cancer.

COHEN, I. Composition for treatment of menopause. 27 January 2009.

Patent applications

US 2009/0035741 A1 Rigid birth simulator having an interactive optical display.

This patent application relates to a birth simulator to be used for training midwives and obstetricians. It has an interactive optical display and a force/movement sensor connected to a computer, which allows the natural movement of the baby to be simulated and displayed on the screen. Various scenarios, which can arise during childbirth can be simulated and visualised graphically allowing for obstetric manipulations to be learned or taught more effectively.

Riener, Robert., Burgkart, Rainer. Rigid birth simulator having an interactive optical display. 5 February 2009.

WO 2009/019215 A1 Method for prenatal diagnosis using exosomes and CD24 as a marker.

This application relates to the identification of exosomes (tiny membrane vesicles released by cells) found in body fluids, using a biomarker, for example, CD24. The inventors have found that amniotic fluid and newborn urine contain exosomes derived from fetal kidneys. These contain polypeptides involved in cell–cell communication (Proteomic profiling of exosomes: current perspectives. Simpson RJ, Jensen SS, Lim JW. Proteomics 2008;8:4083–99). It is hoped that analysis of exosomes from amniotic fluid will eventually provide an accurate and reliable way of performing prenatal diagnosis.

Altevogt, PA., Keller, S. Method for prenatal diagnosis using exosomes and CD24 as a marker. 12 February 2009.

US 2009/0028891 A1 Chlamydia antigens and uses thereof.

Having identified Chlamydia nucleic acids that encode protein antigens, the inventors aim to use this knowledge to develop new methods for detecting and preventing Chlamydia or Chlamydophilia infection. This application relates to a pharmaceutical composition comprising an isolated protein containing a specific amino acid sequence and a pharmaceutically acceptable carrier, diluent or excipient. A pharmaceutical composition that can be used as a vaccine against Chlamydia is also proposed. Interestingly, the team have made significant progress developing a Chlamydia vaccine for koalas! (Queensland University of Technology [19 July 2008]).

Vaccine For Koala Chlamydia Close. ScienceDaily. (http://www.sciencedaily.com/releases/2008/07/080717102417.htm).

Timms, P., Beagley, K., Hafner, L. Chlamydia Antigens and Uses Thereof. 29 January 2009.

Legal matters

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  2. International guidelines/reports
  3. Clinical trial recruitment
  4. Patent news
  5. Legal matters

Forcibly sterilised woman files international case against Chile

A complaint has been submitted to the Inter-American Commission on Human Rights on behalf of a Chilean, HIV positive woman, who claims that the Chilean government failed to protect her rights after she was sterilised, following childbirth, without consent. Both the Chilean Ministry of Health and Courts have previously denied that this was a violation of her human rights. However, a study carried out in 2004 by a Chilean based HIV/AIDS service organisation, VIVO POSITIVO, found that 29% of Chilean women had been pressurised by medical staff to be sterilised after pregnancy and 12.9% did not give their consent.

Obama rescinds Global Gag Rule

The US Global Gag Rule has recently been repealed by President Obama. This US policy banned US-funded family planning organisations, working internationally, from discussing or providing any abortion related services to women. Organisations were forced either to limit the range of reproductive health options they offered women or, if they chose to ignore the ban, lose essential funding. The Global Gag Rules affected family planning organisations working in 60 countries worldwide.