International guidelines/reports

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  3. Clinical trial recruitment
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Evidence-based guidelines for youth peer education

These guidelines developed by the Inter Agency Youth Working Group aim to improve the quality and success of peer education. A popular method of promoting reproductive health and HIV prevention, peer education programmes aim to improve health-related knowledge, attitudes, skills and access to health services among young people. However, programmes often face difficulties regarding a lack of community support and problems relating to the recruitment, retaining, training and supervision of peer educators, which can badly affect the impact of the programme. These guidelines have been developed by international experts and provide detailed evidence-based information highlighting successful aspects of peer education programmes, information regarding how to build a successful peer education programme and checklists and action planning tools to help programme managers, policy makers and others to develop high-quality peer education programmes to improve reproductive and sexual behaviour among young people.

Atlas eHealth country profiles, Global Observatory for eHealth series—volume 1

This atlas, produced by the World Health Organization, reports the findings of the second global survey on eHealth. The atlas provides a detailed overview of the state of ehealth in the 114 World Health Organization member states that participated in the 2009 global survey on ehealth. The report comprises individual country profiles, describing the current status of the use of information and communication technologies and providing information regarding the progress of eHealth initiatives. Each profile includes information about policy frameworks, legal and ethical frameworks for eHealth, eHealth expenditure and funding sources, capacity building, telemedicine, mHealth (mobile health) and elearning. This report provides a fascinating insight into the extent of development of eHealth initiatives around the world.

Sexually transmitted diseases treatment guidelines, 2010

These guidelines produced by the Center for Disease Control and Prevention were updated following a consultation with experts between 18 and 30 April 2009. The new guidelines reflect updated evidence including: (1) expanded diagnostic evaluation for cervicitis and trichomoniasis; (2) new treatment recommendations for bacterial vaginosis and genital warts; (3) the clinical efficacy of azithromycin for treating chlamydial infections during pregnancy; (4) the increasing prevalence of antimicrobial-resistant Neisseria gonorrhoeae; (5) diagnostic evaluation after sexual assault; and (6) sexually transmitted disease (STD) prevention strategies. The guideline also outlines five strategies for prevention and control of STDs and provides detailed information on the management of special populations such as pregnant women and adolescents. This document provides comprehensive advice on the management of STDs and will be particularly useful for health professionals with an interest in sexual reproductive health as well trainees sitting postgraduate examinations.

International Data Center

The Guttmacher Institute has recently launched a valuable new tool allowing researchers, policy makers and other professionals working in reproductive health to build, download and print custom-designed tables, country profiles and maps. The tool uses the most up-to-date information available from 22 regions and 75 countries. A clickable map is provided for ease of access to individual country indicators. Comprehensive indicators for contraception, pregnancy and adolescents are provided and the tool allows for individual indicators to be selected and mapped to all countries allowing researchers the ability to create custom-built tables and maps comprising any of the given information included in the country indicators section. Country summaries are also available listing all the available indicators. However, data from some countries like Canada, Australia and most countries in the European Union including the UK are not available.

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.

LANDA embryo freezing technique

This observational study aims to investigate the outcome of women who received embryo cryopreservation as part of their assisted reproductive technology treatment, particularly in terms of post-thaw survival and pregnancy rates.

Inclusion criteria: Infertile women whose physician has recommended in vitro fertilisation and who agree to cryopreserve surplus embryos; women with cancer who wish to preserve their fertility before cancer treatments; recipients who wish to use frozen donor embryos; a male partner whose semen analysis meets the clinic criteria for intracytoplasmic sperm injection; be willing and able to comply with the protocol for the duration of the study; have voluntarily provided written informed consent.

Primary outcome measures: Freeze–thaw survival rates; blastocyst formation rates; pregnancy rate.

Trial site: California, USA.

Anticipated trial end date: January 2012.

Progesterone and second-trimester bleeding

This randomised trial aims to determine if progesterone treatment affects the incidence of preterm labour in women with second-trimester bleeding compared with placebo. Women will receive either micronised progesterone 200 mg as an intravaginal tablet once daily or placebo. Treatment will begin not before 16 weeks of gestation and will continue until 36 weeks of gestation.

Inclusion criteria: Viable pregnancy; gestational age between 13 and 26 weeks; vaginal bleeding from uterine origin; singleton pregnancy; normal clotting tests; haemodynamically stable woman.

Primary outcome measure: Incidence of spontaneous preterm birth before 37 weeks.

Secondary outcome measures: Maternal and fetal outcomes.

Trial site: Afula, Israel.

Anticipated trial end date: December 2013.

Prospective evaluation of Keat electrostimulator in the auto-reeducation of female urinary incontinence

This observational study assesses the effectiveness, in terms of the objective cure rate, after 2 months (four times per week) of electrical stimulation using the Keat® stimulator in women with stress, urge and mixed incontinence. The Contilife® questionnaire will be used to assess health-related quality of life.

Inclusion criteria: Women; age >18 years; stress, urge or mixed incontinence with indication of perineal re-education; follow up in gynaecology.

Primary outcome measure: Change of quality of life after electrostimulation.

Secondary outcome measures: Change of urinary handicap after electrostimulation; satisfaction after electrostimulation.

Trial site: Various locations, France.

Anticipated trial end date: October 2011.

Mirena intrauterine system (LNG-IUS) timing of insertion: a randomised controlled trial (MISTIC)

This randomised controlled trial aims to determine the effect of timing of levonorgestrel intrauterine system (LNG-IUS) insertion on the number of LNG-IUS still in the correct position after 6 months postpartum. Women will be enrolled at a minimum of 36 weeks of gestation and will be randomised to receive either immediate post-placental delivery insertion of the LNG-IUS or the more usual insertion at 4–8 weeks postpartum. All women will be followed up at 4–6 weeks after insertion and 6 months postpartum to confirm the correct position of the LNG-IUS. This is a sub-study of the Contraceptive Choice Project, which has already enrolled over 5000 women and is a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers to access.

Inclusion criteria: Age 14–45 years; vaginal delivery at Barnes-Jewish hospital; sexually active with male partner; no tubal ligation/hysterectomy; not currently using contraception; desire reversible contraception; reside in St Louis City/County; requests Mirena intrauterine device for contraception.

Primary outcome measure: Mirena in place.

Secondary outcome measures: Mirena expulsion; uterine perforation; intrauterine infection.

Trial site: Missouri, USA.

Anticipated trial end date: June 2011.

Patent news

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Granted patents

US 7854237 Fetal monitoring transducer aligning device.  This granted patent relates to the invention of an improved interface apparatus for ultrasonic fetal heart rate monitoring devices that allows for better positioning of the electronic transducers on women during labour. Specifically this invention aims to solve the problem of the difficulty in correctly placing or in maintaining the transducer in the correct position on the abdomen by employing an adaptive device that can be coupled over a fetal monitoring transducer. This allows for accurate fetal heart rate recordings by providing a means for easily and quickly adjusting the direction of the transducer ultrasound beam. The device consists of five fillable chambers with each chamber having a resiliently deformable side-wall. Air can be selectively pumped or released into any combination of chambers. When coupled to an ultrasonic transducer, the selective use of air pressure in the bladder more precisely aligns the ultrasound beam from the transducer to improve fetal heart movement detection. The various embodiments of this invention have been designed to work in conjunction with all currently used fetal monitoring transducers.

Irland, N.-B. Fetal monitoring transducer aligning device. 21 December 2010.

US 7855190 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration.  This granted patent relates to the invention of a contraceptive regimen for increasing contraceptive effectiveness in higher weight women (about 70 kg or more), comprising administering a combination of estrogen and progestogen for a period of 81–110 consecutive days, followed by estrogen for 2–10 consecutive days. Besides being used as a contraceptive regimen, this invention can also reduce breakthrough bleeding by providing a regular, predictable withdrawal bleed, reducing the frequency of withdrawal bleeds, and inducing amenorrhoea, which is useful in treating a number of other gynaecological conditions such as endometriosis.

Bell, R.G., Ben-Maimon, C.S., Iskold, B., Bronnenkant, L.J., Hait, H., Reape, K.Z. Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration. 21 December 2010.

US7838647 Non-invasive detection of fetal genetic traits.  This granted patent outlines a method of non-invasive detection of fetal genetic traits by extracting fetal DNA from a substantially cell-free sample of blood plasma or serum from a pregnant woman. Methods are claimed for separating circulating extracellular DNA of 500 base pairs or smaller. An examination of circulatory extracellular fetal DNA and circulatory extracellular maternal DNA in maternal plasma has shown that the majority of the circulatory extracellular fetal DNA has a relatively small size of 500 base pairs (or smaller), whereas the majority of circulatory extracellular maternal DNA in maternal plasma has a size >500 base pairs. It is hoped that fetal traits including fetal RhD gene in pregnancies at risk for haemolytic disease of the newborn, fetal Y chromosome-specific sequences in pregnancies at risk for X chromosome-linked disorders, chromosomal aberrations, hereditary Mendelian genetic disorders and corresponding genetic markers, and traits that are decisive for paternity determination can be identified.

Hahn, S., Holzgreve, W., Zimmerman, B., Li, Y. Non-invasive detection of fetal genetic traits. 23 November 2010.

Patent applications

US 2010/0285974 A1 Identification of ectopic pregnancies.  This patent application relates to the invention of methods to identify extrauterine pregnancies by screening samples for the presence of molecules known to be markers for extrauterine pregnancy. Specifically, the invention involves the screening of samples provided by women to determine levels of one or more of the inhibin/activin βB subunit gene, activin B, cysteine-rich secretory protein 3 (CRISP-3) and/or carboxypeptidase-B1 (CPB1), SLP1, elafin, prolactin. Particular levels of inhibin/activin βB subunit gene, activin B, CRISP-3 and/or CPB1 are associated with, or indicative of, an ectopic pregnancy.

Horne, A., Critchley, H., Burgess, S. Identification of ectopic pregnancies. 11 November 2010.

Legal matters

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  2. International guidelines/reports
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  5. Legal matters

Anti-choice lawmakers introduce ‘bait and switch’ Bill aimed at banning abortion coverage

A bill introduced in the USA by House Republicans proposes to introduce a range of new tax penalties on both individuals and businesses that will make abortion unavailable under health insurance policies. The bill, referred to as the ‘bait and switch bill’ is being promoted as a means to end taxpayers funding of abortion services in the USA.

  1. Shona Kirtley, Women’s Health Researcher. Patrick Chien, Consultant Obstetrician and Gynaecologist, Ninewells Hospital, Dundee, UK.