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International guidelines/reports

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  2. International guidelines/reports
  3. Clinical trial recruitment
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Assisted reproductive technology in Australia and New Zealand 2007

This report, published by the Australian Institute of Health and Welfare National Perinatal Statistics Unit, is a detailed analysis of assisted reproductive treatment (ART) provided to couples in Australia and New Zealand in 2007. The treatments discussed are: autologous in vitro fertilisation (IVF) using both fresh and thawed embryos, with intracytoplasmic sperm injection and preimplantation genetic diagnosis; IVF with oocyte donation or surrogacy; gamete intrafallopian transfer; and donor sperm insemination. The report reviews both the pregnancy and birth outcomes following treatment and discusses complications. The authors state that the most important trend identified in 2007 was the reduction in the rate of multiple births (from 18.7% in 2003 to 10% in 2007) following ART. This is largely the result of the shift to single embryo transfer (SET), with the proportion of SET cycles increasing from 32% in 2003 to 63.7% in 2007, during which time the clinical pregnancy rates have remained stable at 22%.

In a related report, the American Society for Reproductive Medicine has recently released revised guidelines in an attempt to reduce further the multiple pregnancy rates in the USA. The guidelines explicitly state that no more than one embryo above the number recommended in the guidelines should be transferred in women with a poor prognosis. In addition, there should be no difference in the numbers of fresh or frozen embryos that are transferred. (http://www.asrm.org/Media/Press/AM09_embryoguides.html)

World Health Organization country profiles for maternal and child health

The Making Pregnancy Safer programme at the World Health Organization (WHO) has recently launched a series of 78 country profiles to highlight, in a visual format, maternal and newborn health service coverage in developing countries. These profiles were compiled using data collected by each country through the Demographic and Health Surveys, the Multiple Indicator Cluster Surveys and various other national surveys. Reported statistics include: number of antenatal care visits; skilled birth attendant at delivery; place of delivery; caesarean section rate; low birthweight; perinatal mortality rate; family planning; fertility; HIV in pregnancy, and infant mortality rate. The aim of the country profiles is to assist with programme planning, decision-making and advocacy both within each country and also internationally.

Each profile provides a clear snapshot of where that country is in terms of the reproductive health indicators mentioned above. One of the clear messages from many profiles is the disparity in outcomes between urban and rural dwellers. The manifold reasons present a complex problem that requires careful thought and insight by skilled policy developers.

Active management of the third stage of labour: prevention and treatment of postpartum haemorrhage

This guideline, published in October 2009 by the Society of Obstetricians and Gynaecologists of Canada, gives guidance regarding the prevention, identification and management of postpartum haemorrhage (PPH). A comprehensive list of the risk factors for PPH, as well as a summary table outlining the treatment options and diagrams illustrating the B-Lynch and Cho techniques for uterine compression sutures, are provided. Consistent with the 2009 RCOG guidelines on PPH, active management of the third stage of labour is recommended, as is the use of intramuscular oxytocin (10 IU) for all low-risk women.

World Health Organization has also recently produced guidelines for the management of PPH and retained placenta, which aim to give healthcare workers answers to questions that were regarded as high priority by an international multidisciplinary panel (http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241598514/en/index.html).

Together, both documents provide an excellent synthesis of the current, best, evidence-based practice for the management of PPH. Clearly, if adequate resources are available and these guidelines are followed, then the associated high maternal morbidity and mortality rates in many regions of the world should, in theory, fall.

Strategic considerations for strengthening the linkages between family planning and HIV/AIDs policies, programmes and services

This report, produced by WHO, US Agency for International Development (USAID) and Family Health International (FHI), with contributions from other key international organisations, has been compiled in response to increasing calls for strategies to strengthen the linkages between family planning and HIV/AIDs programmes, services and polices. The report states that a recent Cochrane review on reproductive health and HIV (AIDS 2009;23:S79–88) concluded that integrating these services was feasible; however, there is little evidence currently available on the practicalities of integration. This report brings together expert opinions, evidence from published literature and experiences from the field to highlight, using examples, how different aspects of each service could be integrated. The benefits and challenges of integration are outlined and lists of useful resources, including several links to relevant websites, are provided.

Termination of pregnancy worldwide: a decade of uneven progress

Published by the Guttmacher Institute, this report outlines the provision of termination of pregnancy (TOP) services around the world and assesses their legality, safety and accessibility. It discusses developments and policy changes over the last decade and highlights the progress that has been made. Encouragingly, the rates of contraception usage have increased (although its use varies markedly between countries) and the number of unintended pregnancies has declined. Unfortunately, the rates of unsafe TOP have changed very little and thousands of women still die (approximately 70 000 each year) from complications of TOP. A number of comprehensive tables are provided including: the legal situation in different countries; TOP rates between 1995 and 2003; fertility rates; unplanned pregnancy rates; and contraceptive behaviour. The report aims to increase awareness and knowledge among policymakers, national and international organisations, programme managers and the general public to promote increased access for all women to legal, safe TOP.

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.

Does ultrasound scanning of the lumbar spine improve patient satisfaction and the ease of inserting epidurals?

This randomised trial aims to determine whether ultrasound scanning of the lumbar spine helps an anaesthetist to insert an epidural catheter in labour. In a previous trial of 300 women, Grau et al. (2002) (http://www.ncbi.nlm.nih.gov/pubmed/12031746)

found that fewer puncture attempts were required with the use of ultrasound. Interventional procedure guidance by National Institute for Clinical Excellence in 2008 (http://www.nice.org.uk/nicemedia/pdf/IPG249Guidance.pdf)

also suggests that ultrasound-guided catheterisation of the epidural space is safe and may help correct placement. However, the procedure is not widely used. This study investigates whether ultrasound guidance aids the insertion of epidurals into women with uncomplicated pregnancies by anaesthetists of various grades.

Inclusion criteria: Requesting epidural analgesia for labour; easily palpable spine.

Primary outcome measure: Ease of epidural insertion by time to perform procedure (minutes); number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.

Secondary outcome measures: Numbers of inadvertent dural punctures and attempts to thread the epidural; success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion); need for anaesthetist to call for assistance; patient satisfaction.

Trial site: Ontario, Canada.

Anticipated trial end date: July 2010.

Study of adding cetuximab to chemotherapy for the treatment of advanced and/or recurrent cervical cancer (MITO CERV 2)

This randomised study aims to assess the effectiveness of a combination of cetuximab [a chimeric monoclonal antibody against epidermal growth factor receptor (EGFR)] with carboplatin and paclitaxel compared with chemotherapy alone. Cetuximab is currently used in the treatment of advanced colorectal and head and neck cancers.

Inclusion criteria: Women with advanced and/or metastatic cervical cancer untreated or having failed only one previous chemotherapy; at baseline, presence of at least one measurable target lesion; not amenable to surgery and/or radiotherapy; performance status 0–1 according to the Eastern Cooperative Oncology Group; age >18 years; life expectancy of at least 3 months; adequate organ function; no other invasive malignancy within the past 5 years except non-melanoma skin cancer; all radiology studies to be performed within 28 days of randomisation.

Primary outcome measure: Event-free survival.

Secondary outcome measures: Toxicity; overall survival; skin toxicity and correlation with cetuximab activity; expression of EGFR and KRAS (a biomarker predictive of response to cetuximab in colorectal cancer) correlated with cetuximab activity.

Trial site: Various locations, Italy.

Anticipated trial end date: March 2011.

Integrating family planning services into HIV care and treatment in Nyanza Province, Kenya

This cluster randomised trial aims to determine the viability of integrating family planning services into HIV care and treatment programmes in 18 sites in various districts of Kenya. As mentioned in the joint WHO, USAID and FHI report above, linkages between these two services are recommended but limited information is available regarding the practicalities of doing so. This study will have three parts. For the first 3 months, baseline data on contraceptive prevalence and unintended pregnancy rates, as well as information about attitudes and practices related to family planning, will be collected. The second phase (3 months) consists of integrating family planning services and HIV services in 12 sites. During the third phase (9 months) data on contraceptive prevalence and unintended pregnancy will be collected from all 18 sites. Information about knowledge, attitudes and practices will be collected; questionnaires will also be distributed to assess the acceptability of family planning services to participants.

Inclusion criteria: Non-pregnant HIV-positive women aged 18–45 years, or HIV-positive men aged 18 years and above, receiving HIV care at the health facilities.

Primary outcome measure: Contraceptive prevalence; pregnancy rates.

Secondary outcome measures: Knowledge of contraceptive methods among HIV-positive women and providers; acceptability of family planning services; feasibility of providing family planning services at HIV care and treatment centres; reproductive intentions of HIV-infected women.

Trial site: Migori, Kenya.

Anticipated trial end date: February 2011.

A pilot study of acupoint injection for primary dysmenorrhoea

This study aims to determine the feasibility, acceptability and efficacy of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhoea in the USA. In China, menstrual pain has been managed in this way for over 20 years and there is some evidence that it is effective (Wang et al. 2004 http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=15775872).

In the current study, 20 women will be randomised to receive either vitamin K1 injection into an acupuncture point within 2 days of the onset of menstrual cramps followed by a saline injection in a non-acupuncture point 2 months later, or a saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point 2 months later. Three additional participants will be recruited who will receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and afterwards to assess vitamin K1 absorption. Data on other menstrual symptoms will be collected during an online survey or telephone interview.

Inclusion criteria: Severe primary dysmenorrhoea; 18–25 years old; nulliparous; no acute or chronic conditions diagnosed or suspected; not on hormonal contraceptives; regular menstrual cycles for at least 6 months.

Primary outcome measure: Self-reported pain.

Secondary outcome measures: Medications used during menstrual cycle; activity restriction; vitamin K content in blood; Cox retrospective symptom scale.

Trial site: California, USA.

Anticipated trial end date: December 2010.

Postoperative continuous active combination sex steroids for the prevention of recurrent endometrioma formation

This randomised study aims to investigate whether continuous combined oral contraceptive pills (COCP) administered after surgery decrease the risk of recurrent endometrioma formation. Thirty-five women will be enrolled in each arm and will receive either a monophasic COCP or placebo. Follow up will be 2, 6, 12, 18 and 24 months after surgery, and will include vaginal and rectal examination as well as ultrasound scanning.

Inclusion criteria: Women with an ovarian endometrioma that has been surgically removed.

Primary outcome measure: Endometrioma recurrence rate.

Trial site: Oklahoma, US.

Anticipated trial end date: October 2011.

Whether or not to use hormonal treatment postoperatively to prevent endometrioma recurrence is a controversial issue, which clearly needs more research. The Royal College of Obstetricians and Gynaecologists Guideline on endometriosis states that postoperative hormonal treatment appears to have no effect on disease recurrence, but the recommendation is based on a Cochrane review that has not been updated since 2004. It is interesting to note, therefore, that a recent randomised controlled trial involving an Italian group of 239 women with laparoscopically removed ovarian endometriomas found that both continuous and cyclic use of COCPs reduced the recurrence rate (Seracchioli et al. Fertil Steril 2008 Oct 28 [epub ahead of print]). A similar conclusion is drawn from a retrospective study just published (Takamura et al. Hum Reprod 2009 Aug 14 [epub ahead of print]).

Patent news

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

Granted patents

EP 1421112/B1 Novel serine protease.

This granted patent describes an in vitro method of detecting the expression of an enzyme pregnancy related serine protease (PRSP), for diagnosing infertility caused by an inability to achieve or sustain embryo implantation. The method is also claimed for detecting impending miscarriage.

This protein is expressed in the endometrium, decidua and placenta and is thought to be associated with embryo implantation and placentation. It may therefore have potential uses in the evaluation of fertility, in diseases such as pre-eclampsia and in intrauterine growth restriction, and as a target for contraception.

Nie, G., Salamonsen, LA., Findlay, JK. Novel serine protease. 7 October 2009.

EP 1863470/B1 A method for preventing and/or treating vaginal and vulval infections.

This granted patent relates to the use of gallic acid to inhibit and/or kill Trichomonas vaginalis and Gardnerella vaginalis without affecting the growth of Lactobacilli. With the advantage of topical application, the method would be preferable to other treatments that involve oral administration of antibiotics with their subsequent systemic side effects.

Huang, L., Yang, Sh. A method for preventing and/or treating vaginal and vulval infections. 14 October 2009.

Patent applications

WO 2009/128956 A1 Use of a steroid profile in ovarian follicular fluid for diagnosis, prognosis and determining strategies for treatment.

This patent application claims a method of determining steroid profiles obtained from ovarian follicular fluid as biomarkers for the diagnosis and treatment of polycystic ovary syndrome. The method is also claimed to be useful for determining the viability of oocytes for successful IVF outcome, guiding a treatment or for use in embryonic stem cell-related procedures.

Kushnir, M., Naessen, TGK., Bergquist, JR. Use of a steroid profile in ovarian follicular fluid for diagnosis, prognosis and determining strategies for treatment. 22 October 2009.

WO 2009/125300 A2 Oxygenation procedures for newborns and devices for use therein.

The invention claims a method for resuscitating preterm neonates that includes administering a concentration of 90–100% supplementary oxygen; monitoring oxygen saturation levels, and reducing the supplementary oxygen concentration by 20% every 10–20 seconds until the saturation levels reach the desired level. An oxygen delivery module, an oxygen monitor and a display and warning system are also claimed.

There is controversy regarding the levels of oxygen that neonates should receive (with different levels required for term and preterm neonates). The British (http://www.resus.org.uk/pages/nls.pdf)

guidelines summarise the evidence and the uncertainties (up to 2005) on this subject.

Rabi, Y. Oxygenation procedures for newborns and devices for use therein. 15 October 2009.

Legal matters

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

Center applauds Senate Committee for rejecting anti-abortion amendments, calls for no political games on Senate floor

The Senate Finance Committee has recently considered the US healthcare reform bill. The Committee has rejected an amendment by Senator Hatch, intended to limit women’s access to TOP by extending the funding restrictions for TOP services. The proposed amendment would ban any federal money being used to pay for TOP services and would require women to buy a separate, supplemental insurance plan to cover TOP. In addition, the Center for Reproductive Rights expresses concerns about the implications of the Capps amendment that was passed in July 2009, which it feels may ultimately also stop private insurance companies offering TOP coverage.