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International guidelines/reports

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Young women and abortion: a situation assessment guide

This International Pregnancy Advisory Services Youth Programme assessment guide has been produced as a tool for programme managers, trainers, peer educators and community and youth groups to use for ensuring that the sexual and reproductive health services that they provide are both accessible and appropriate to both the young women and the communities that they serve. The guide focuses on detailing the methodology that should be followed when carrying out a situation assessment to determine how young women and individual communities relate to termination of pregnancy. The assessment should aim to identify and remove current barriers to termination of pregnancy care and provide evidence to inform the redesigning of services to ensure that all young women have access to locally relevant and appropriate termination of pregnancy information and care relevant to the circumstances in which they live. Comprehensive information is provided regarding the planning, implementation and analysis of a situation assessment and recommendations are made regarding how to use the data obtained to improve the delivery of local termination of pregnancy services.

Monitoring maternal, newborn and child health: understanding key progress indicators

This report, co-produced by Countdown to 2015 and the Health Metrics Network, presents the 11 key indicators of the Commission on Information and Accountability for Women’s and Children’s Health as a means of monitoring progress towards the achievement of Millennium Development Goals 1, 4, 5 and 6 by 2015: maternal mortality ratio; under-five mortality ratio (with the proportion of newborn deaths); stunting prevalence; demand for family planning satisfied (met need for contraception); antenatal care (four or more visits); antiretrovirals for HIV-positive pregnant women; skilled attendant at birth; postnatal care for mothers and babies within 2 days of birth; exclusive breastfeeding (up to 6 months); three doses of combined diphtheria–tetanus–pertussis (DTP3) vaccine immunisation coverage; antibiotic treatment for childhood pneumonia. The information required to be captured for each indicator is outlined including programme relevance, data source and data availability and suggestions are provided for specific data capture areas that require improvement. Recommendations for resource tracking and equity analyses are also outlined and the extent to which health information systems in individual countries have the capability and resources to report on each of the indicators is discussed.-pertussis (DTP3).

Safe pregnancy and birth mobile app

Hesperian Health Guides recently launched an iPhone app focusing on safe pregnancy and birth. Freely available from the iTunes store the app is currently a proof of concept app and is Hesperian’s first involvement in mHealth, which is the practice of medicine or the provision of health services supported by mobile telecommunication and multimedia technologies using wireless devices such as mobile phones, tablet computers and personal digital assistants (palmtops). Designed specifically for community health workers and midwives working in low and middle income countries, the app contains information on staying healthy during pregnancy, recognising danger signs during the antenatal, intrapartum and postnatal periods and what action to take, when to refer to emergency care and a set of key instructions with step-by-step explanations on how to cope with certain situations. Although the availability of smart phones among community health workers and midwives in these settings is limited, Hesperian hope that the app will also be used by health professionals working overseas, missionaries and Peace Corps volunteers. Hesperian is also currently developing this app for android phones.

Global fistula care map

This interactive online map, produced by the Fistula Foundation, Direct Relief International and the United Nations Population Fund, provides a visual representation of areas in the world where fistula treatment is provided with graphics indicating the total number of women with fistulae within each area. Clicking on the map displays details of individual health facilities that provide obstetric fistula services as well as information about the type of hospital, number of women receiving fistula care, the number of dedicated hospital beds for women with fistulae and the number of specialist fistula surgeons. Information is also provided on an area-by-area basis regarding births not attended by a skilled health professional, the percentage of women that did not receive antenatal care, the maternal mortality risk, the percentage of the population living below the poverty line and the population density. Currently there are data from 328 individual health facilities (located mainly in the African continent, Pakistan and Bangladesh) included in the map. The data were obtained in July 2011 via a survey distributed to over 300 health facilities in 47 countries by Direct Relief International. It is hoped that the map will become more comprehensive as new information and data from countries around the world become 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.

Botulinum toxin for pelvic pain in women with endometriosis

This double-blind randomised trial aims to determine the efficacy of botulinum toxin injections into the pelvic floor muscles through the vaginal walls on pelvic pain levels and pelvic muscle spasms in women with endometriosis.

Inclusion criteria: Female gender; aged between 18 and 50 years; history of endometriosis at surgery; persistent pelvic pain for at least 3 months; pelvic floor spasm; negative pregnancy test; willing to use reliable method of contraception for the month after botulinum toxin injection; willing and able to give informed consent; willing and able to comply with study requirements.

Primary outcome measure: Improvement in pain (a binary measurement of improvement/no improvement will be used).

Secondary outcome measures: Need for re-injection at 1 month as a binary measurement of yes/no; change in pelvic pain (pain visual analogue score); botulinum toxin patient response inventory; standardised pelvic pain questionnaire; standardised quality of life questionnaire.

Study site: Maryland, USA.

Anticipated study end date: June 2014.

Intensity modulated radiation therapy with cisplatin and gemcitabine to treat locally advanced cervical carcinoma

This phase I trial aims to determine the highest dose of gemcitabine (weekly infusion for 5 weeks at escalating dose levels: 50 mg/m2, 75 mg/m2, 100 mg/m2 and 125 mg/m2) that can be safely administered along with cisplatin (weekly infusion of 40 mg/m2 for 5 weeks; 70 mg maximum) and pelvic intensity-modulated radiation therapy (IMRT; 45 Gy in 25 daily fractions) to women with locally advanced cervical cancer. It is hypothesised that IMRT will cause a reduction in gastrointestinal and haematological toxicity, so allowing for escalating doses of gemcitabine to be administered safely.

Inclusion criteria: Histologically-proven, invasive primary carcinoma of the cervix; stage IB2–IVA cervical cancer or stage I with biopsy-proven pelvic node metastases, positive surgical margins, or parametrial extension based upon standard diagnostic workup.

Primary outcome measure: Establish the maximum tolerated dose of gemcitabine that can be safely administered in combination with cisplatin.

Secondary outcome measures: Number of participants with acute adverse events as a measure of safety and tolerability; number of participants with progression-free survival as a measure of response.

Study site: California, USA.

Anticipated study end date: August 2014.

Early screening and treatment of women with prediabetes in pregnancy

This randomised controlled study aims to investigate whether treating pregnant women who have prediabetes with medical nutrition therapy involving dietary counselling (twice weekly visits to dietitian), exercise (brisk walking for a minimum of 30 minutes each day) and self blood glucose monitoring (four times per day) will decrease both the rate and severity of impaired glucose tolerance in later pregnancy and also whether medical nutrition therapy improves perinatal outcomes.

Inclusion criteria: Aged 18 years or older; singleton pregnancy; prenatal care established at <14 weeks; haemoglobin A1C 5.7–6.4%; delivery planned at Lucille Packard Children’s Hospital at Stanford University or Santa Clara Valley Medical Center.

Primary outcome measure: Diagnosis of gestational diabetes at 26 weeks of gestation by oral glucose tolerance test.

Secondary outcome measures: Route of delivery; gestational weight gain; haemoglobin A1C at delivery and change over time; fasting triglycerides; gestational hypertension; blood pressure ≥140/90 mmHg after 20 weeks of gestation; pre-eclampsia; abnormal oral glucose tolerance test 6 weeks postpartum; need for insulin therapy; neonatal birthweight and length; ponderal index; umbilical cord C-peptide 90%; neonatal hypoglycaemia; neonatal hyperbilirubinaemia; birth injury or shoulder dystocia; fetal or neonatal death.

Study site: California, USA.

Anticipated study end date: September 2014.

Combination therapy with myo-inositol and folic acid versus myo-inositol alone

This randomised study aims to investigate the role of folic acid combined with myo-inositol in women with polycystic ovary syndrome on the restoration of spontaneous ovarian activity. Fifty women will be randomised to receive either myo-inositol 1500 gr daily or myo-inositol 2000 gr plus folic acid 200 μg daily. Effects after 6 months of treatment on clinical, endocrine and metabolic features will be recorded.

Inclusion criteria: Women with polycystic ovary syndrome diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003; body mass index >25 kg/m2; aged 18–35 years.

Primary outcome measure: Number of cycles in 6 months of therapy.

Secondary outcome measures: Effects on oral glucose tolerance test; effects on hormonal assay; effects on lipid profile.

Study site: Rome, Italy.

Anticipated study end date: Not specified.

Pharmacogenetics of remifentanil in patients with hypertension undergoing caesarean delivery under general anaesthesia

This double-blind randomised study aims to investigate the influence of remifentanil administered at a bolus dose of 1 μg/kg given 30 seconds before induction to general anaesthesia to women with hypertension undergoing caesarean section in terms of haemodynamic stability and newborn safety. The participants in the placebo arm will receive a bolus dose of saline (placebo) 30 seconds before induction to general anaesthesia. General anaesthesia during caesarean section is usually accompanied by an exaggerated autonomic stress reaction with maternal hypertension and tachycardia. The use of an ultra-short acting opioid such as remifentanil should suppress the stress response in the mother without increasing the risk for the newborn. The investigators also wish to assess variation in individual responses to remifentanil.

Inclusion criteria: Pregnant women; aged 18+; caesarean delivery under general anaesthesia and informed consent.

Primary outcome measures: Haemodynamic response to intubation and beginning of caesarean operation; newborn adaptation after delivery.

Secondary outcome measures: Depth of anaesthesia.

Study site: Prague, Czech Republic.

Anticipated study end date: June 2013.

Patent news

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Granted patents

US 8123773 Postpartum hemorrhage balloon tamponade catheter. This US granted patent outlines the apparatus and methods for a balloon tamponade catheter designed to control uterine postpartum haemorrhage. Specifically, this invention consists of a catheter with an expandable pear-shaped balloon located distally on the catheter body to allow insertion into the uterus. The balloon tamponade is inflated with fluid to apply pressure to the interior surface of the uterus, which should stop or control bleeding in women with postpartum haemorrhage. The inventors also state that this tamponade design could have a number of additional applications including the control of vaginal bleeding.

Shirley, B.D. Postpartum hemorrhage balloon tamponade catheter. 28 February 2012.

Patent applications

US 2012/0046185 A1 Panel of biomarkers for ovarian cancer. This US patent application discusses the identification of a panel of protein-based biomarkers that can help to determine whether an ovarian tumour is malignant or benign and outlines methods and kits for the preoperative assessment of ovarian tumours. Specifically, a serum sample taken from the woman is examined for the presence of CA125, transthyretin (prealbumin), apolipoprotein A1, β2-microglobulin and transferrin and a diagnosis of ovarian cancer is made if the woman is identified as having an increase in the amount of β2-microglobulin, an increase in the amount of CA125, a decrease in the amount of transthyretin (prealbumin), a decrease in the amount of apolipoprotein A1, a decrease in the amount of transferrin or a combination of the above.

Chan, D.W., Zhang, Z., Fung, E. Panel of biomarkers for ovarian cancer. 23 February 2012.

US 2012/0052595 A1 Detection of amniotic fluid in vaginal secretions of pregnant women due to premature rupture of fetal membranes. This US patent application proposes a method for the accurate determination of premature rupture of membranes (PROM) by detecting the presence of polyclonal antibodies using a chromatographic specific binding assay strip device. Monoclonal and polyclonal antibodies are positioned on a lateral flow assay test strip as they are specifically reactive with certain amniotic fluid proteins, the presence of which can be used to detect PROM. To ensure that the test results obtained are as accurate as possible, a lateral flow assay strip is used to test for a minimum of two antigens and a built-in timer is included within the cassette securing the lateral flow assay. The inventors state that the use of this method reduces the level of false negatives from more than 10% to virtually zero.

Wallace, W.D., Ford G. Detection of amniotic fluid in vaginal secretions of pregnant women due to premature rupture of fetal membranes. 1 March 2012.

Legal matters

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  2. International guidelines/reports
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Israel: biological mother recognised as parent in landmark surrogacy decision

A legal precedent was recently set in Tel Aviv where a family court judge has officially recognised a woman whose twins were born via an overseas surrogate as the legal parent. Israeli law already legally recognises parenthood status resulting from surrogacy arrangements made within its own borders; however, no law currently exists regarding the legal status of parents who use surrogates overseas. This ruling means that biological mothers of children delivered by surrogates will simply have to provide a DNA sample to prove that the child is theirs and they will then be legally recognised as the parent.

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