International guidelines, patents and trials
Women's health—what's new worldwide
Article first published online: 19 NOV 2012
© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 119, Issue 13, pages 1680–1682, December 2012
How to Cite
Kirtley, S. and Chien, P. (2012), Women's health—what's new worldwide. BJOG: An International Journal of Obstetrics & Gynaecology, 119: 1680–1682. doi: 10.1111/1471-0528.12091
- Issue published online: 12 NOV 2012
- Article first published online: 19 NOV 2012
Caring for the newborn at home: a training course for community health workers
This World Health Organization (WHO) and United Nations Children's Fund (UNICEF) publication provides training materials and guidelines for community health workers to help improve the provision of postnatal care services, increase support for pregnant and lactating mothers and their newborns and encourage women and their families to also seek antenatal and intrapartum care from a skilled healthcare professional. The key objectives of the training course include: helping community health workers develop their communication skills, particularly in regard to building good relationships with families; to improve competence in counselling families about the importance of attending antenatal care, planning for birth in a health facility, home care for pregnant women and appropriate newborn care practices immediately after birth; to increase skills in assessing breastfeeding, the ability to recognise danger signs and awareness of the newborn's weight, deciding whether to refer or provide care at home, and advising families on how to best care for the newborn at home; to improve competence in helping families to provide extra care for a small baby. The training comprises 30 sessions divided into two units: home visits during pregnancy and home visits after birth. Also provided, in addition to the comprehensive training course manual, are: a community health worker register, detailed counselling cards providing guidelines regarding what the community health worker should say and do at each visit, a mother and baby record card, and a referral note. Comprehensive facilitator guides are also provided to help facilitators to both prepare and deliver the course successfully and to supervise field practice. The training course is based on experiences of training community health workers in caring for newborns at home from several studies, particularly the SEARCH research study in India and the NEW HINTS study in Ghana.
Building a future for women and children: the 2012 report
This ‘countdown to 2015’ report highlights both the progress of and barriers to individual countries achieving Millennium Development Goals (MDGs) 4 and 5. Countdown 2015 is a global initiative, involving international agencies, professional organisations, donors, nongovernmental organisations, academics and governments, that aims to support, encourage and track progress towards achieving the MDGs—in particular, goals 4 and 5 relating to child mortality and maternal health. Countdown 2015 specifically focuses on highlighting evidence-based solutions and obtaining comprehensive data that can be analysed and used to ensure that stakeholders are held accountable for progress. The report provides comprehensive country-level information listing progress in adopting and implementing relevant policies, information about health systems and financing, levels of equity in coverage and levels of intervention coverage, information about nutrition, water, sanitation, cause of death, infant and maternal mortality ratios and key population characteristics which it is hoped will be used as tools for action. Annex D lists essential interventions for reproductive, maternal, newborn and child health. Key headlines include: maternal mortality has dramatically declined but faster progress is required (only nine [12%] out of the 75 countries included in this report are considered to be on track to achieve MDG Goal 5 and 25 [33%] countries have made insufficient or no progress towards this goal); child mortality has also declined but again more needs to be done; improvements have been made in newborn survival but urgent action is needed with regard to stillbirths, in particular intrapartum stillbirth and preterm birth; many countries included in the report face severe nutrition crises. Haemorrhage and hypertension together account for more than half of all the maternal deaths—defined as deaths of women while pregnant or within 42 days of termination of pregnancy, regardless of the site or duration of pregnancy, from any cause related to or aggravated by the pregnancy or its management. The remaining causes include sepsis (8%) and unsafe termination of pregnancy (9%).
Making health services adolescent friendly: developing national quality standards for adolescent-friendly health services
This guidebook, produced by the Department of Maternal, Newborn, Child and Adolescent Health at the WHO, outlines the public health rationale for ensuring that adolescents have easy access to the health services that they require, in particular to sexual and reproductive health services. Aimed at national public health programme managers, it provides a step-by-step guide on how to develop quality standards for health service provision to adolescents and also provides help in identifying how to practically assess whether these standards have been achieved. The guidebook is divided into three chapters: chapter one focuses upon discussing the theoretical basis for improving the availability of health services specifically designed for adolescents; chapter two outlines a step-by-step process for developing national quality standards for the provision of health services to adolescents, the importance of each step and how this process can be undertaken; and chapter three provides resources and materials that can be used to prepare and run a workshop to develop national standards (Powerpoint presentation slides are also available from www.who.int/entity/maternal_child_adolescent/documents/adolescent_friendly_health_services_2012.ppt). Annex 1 lists the five dimensions of quality health services for adolescents (equitable; accessible; acceptable; appropriate; effective) and annex 2 lists the key actions that are required at national, district and local levels to improve the quality of health service provided to adolescents. This guidebook is intended as a companion volume to the 2009 guidebook produced by the WHO entitled Quality assessment guidebook: A guide to assessing health services for adolescent clients.
Prevention of cervical cancer through screening using visual inspection with acetic acid (VIA) and treatment with cryotherapy: a demonstration project in six African countries
This report, published by the WHO, presents the results of a demonstration project regarding the prevention of cervical cancer by screening using visual inspection with acetic acid (VIA) and treatment with cryotherapy, which began in September 2005 and was completed in May 2009. The project took place over seven sites in six African countries (Malawi, Madagascar, Nigeria, Uganda, the United Republic of Tanzania and Zambia) and targeted women between the ages of 30 and 50 years. The report states that over 250 000 women die from cervical cancer every year and that in sub-Saharan Africa the majority of cancers (over 80%) are diagnosed at a late stage–mainly as a result of a lack of public information provision about cervical cancer and prevention services. The screening programme involves the application of acetic acid to the cervix and macroscopic inspection for aceto-white lesions on the ectocervix and treating such lesions with nitrous oxide cryotherapy on a ‘screen and treat’ basis. This strategy is proposed in a low resource setting instead of the screening with cervical cytology and treating with loop excision usually employed in most developed countries. Women with clinical evidence of cervical carcinoma, aceto-white lesions occupying more than 75% of the cervix or extending more than 2 mm beyond the outer limit of the standard cryotherapy probe, or a lesion extending onto the vaginal wall or more than 2 mm into the cervical canal, were referred to a higher level of health care for further evaluation and treatment. No cervical biopsy was taken before treatment with cryotherapy to confirm the presence of cervical intraepithelial neoplasia (CIN) or to exclude microinvasive cervical carcinoma. Between September 2005 and May 2009, a total of 19 579 women were screened. Overall, 10.1% with VIA results were positive, and 1.7% of these women had lesions suspicious of cancer on inspection. A total of 87.7% of all VIA-positive cases were eligible for cryotherapy. The majority of women (63.4%) received cryotherapy within 1 week of initial screening. The single-visit approach enabled 39.1% of women to be screened and treated on the same day. However, over 39.1% of all women eligible for cryotherapy did not receive treatment, for various reasons, including equipment not being in working order at the time of screening, and women requiring consent from their spouses to receive cryotherapy. Based on the experience of integrating VIA and cryotherapy into reproductive health services during the demonstration project, both service providers and the women who were screened and treated are reported as being satisfied with the service. Women who had cryotherapy were followed-up after 12 months with a repeat VIA assessment. Those women with aceto-white lesions still present at this evaluation were then referred to further assessment at a higher healthcare facility. There was no reporting on the data on outcome of this repeat VIA assessment. At the close of the study country teams proposed plans regarding how to sustain and scale-up cervical cancer prevention services and highlighted barriers such as funding and human resources issues. The report lists a number of recommendations and identifies that provider training, sustainable supervision and reliable supply and maintenance of equipment and consumables will be required to ensure successful scale-up of VIA and cryotherapy services within the six countries.
Clinical study recruitment
Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.
Radical hysterectomy followed by tailored adjuvant therapy versus primary chemoradiation therapy in bulky early-stage cervical cancer (KGOG 1029)
This randomised trial aims to compare 5-year overall survival in women with FIGO stage IB2 and IIA2 cervical cancer who receive radical hysterectomy followed by tailored adjuvant radiation therapy (high-risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40 mg/m2, intravenously for six cycles; extended-field radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis but intracavitary brachytherapy and nodal or parametrial boost is not allowed) or primary chemoradiation therapy (external pelvic radiation with concurrent weekly cisplatin 40 mg/m2 for six cycles, intracavitary brachytherapy, and parametrial or nodal boost with extended-field radiation therapy being allowed in cases of common iliac lymph node enlargement).
Inclusion criteria: Previously untreated, histologically confirmed cervical cancer; FIGO stage IB2 and IIA2 disease; one of following histological types, squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma; Gynecologic Oncology Group performance status: 0–2; adequate organ function; women who have signed an approved informed consent.
Primary outcome measure: 5-year overall survival.
Secondary outcome measures: 5-year progression-free survival; pattern of disease recurrence; treatment-related toxicity; quality of life.
Study site: Seoul, Republic of Korea.
Anticipated study end date: July 2020.
3D ultrasound in women with vacuum or forceps deliveries (VADUS)
This observational, retrospective, case–control study aims to assess, using three-dimensional ultrasound imaging, the differences in pelvic floor anatomy and function of women who have experienced a vacuum-assisted vaginal delivery compared with those who have undergone a forceps-assisted vaginal delivery. Both these groups of study participants are also compared with women who had spontaneous vaginal deliveries and primary elective caesarean section.
Inclusion criteria: Women aged >18 and <45 years; primiparous women with singleton pregnancy who have undergone a term vacuum-assisted vaginal delivery, forceps-assisted vaginal delivery, spontaneous vaginal delivery, or elective primary caesarean section; birthweight >2500 and <4500g; delivery should have occurred >1 year ago but <5 years ago; pregestational body mass index <35 kg/m2.
Primary outcome measure: Levator ani injury on three-dimensional ultrasound.
Study site: New York, USA.
Anticipated study end date: January 2014.
Birinapant for advanced ovarian, fallopian tube and peritoneal cancer
This phase II open-label nonrandomised single-agent study aims to determine the effectiveness of birinapant in women with ovarian, primary peritoneal, or fallopian tube cancer. Women will receive an infusion of birinapant once a week for three consecutive weeks and will then have a break from treatment during week 4 (this constitutes one cycle). Treatment cycles will be continued as long as the cancer does not grow or the adverse effects are not too severe.
Inclusion criteria: Women aged ≥18 years; ability to understand and voluntarily sign written-informed consent and willing and able to comply with the protocol requirements; advanced metastatic or unresectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer that is relapsed and resistant or refractory to prior platinum-based standard-care systemic regimen; women must be at least 4 weeks from previous therapy; women who have had major surgery must be fully recovered and require a recovery period ≥4 weeks before enrolling on the study; histopathological diagnosis must be confirmed in the Laboratory of Pathology, National Cancer Institute; women must have measurable disease by Response Evaluation Criteria in Solid Tumors defined as at least one lesion that can be accurately measured in at least one dimension as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography scan, magnetic resonance imaging, or callipers by clinical examination and a sentinel lesion adequate for core biopsy through percutaneous biopsy; life expectancy >3 months; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; adequate renal, hepatic and bone marrow function; contraception is not a consideration as women have all had surgical removal of their reproductive organs.
Primary outcome measure: Objective response or disease stabilisation for >6 months.
Secondary outcome measure: Overall survival.
Study site: Maryland, USA.
Anticipated study end date: September 2014.
Alteration in hearing following accidental dural puncture. A study in parturients (AHEAD)
This observational study aims to test the hypothesis that, in women who have received epidural anaesthesia during labour, measuring for hearing loss can be a diagnostic tool for confirming the diagnosis of accidental postdural puncture headache (PDPH). It is known that leakage of cerebrospinal fluid from the dural puncture site can result in partial loss of unilateral or bilateral hearing detected by audiometric testing using oto-acoustic emission and auditory steady-state response. Study participants will be recruited into three groups: women with intrapartum epidural analgesia suffering from PDPH will form the experimental group and women with epidural analgesia during labour who did not have symptoms of PDPH and women without intrapartum epidural analgesia will form the two control groups.
Inclusion criteria: Healthy parturients; no known hearing problems; understand Swedish language; informed consent.
Primary outcome measure: Postdural puncture headache.
Secondary outcome measures: Audiometric data; PDPH questionnaire; recurrence of headache.
Study site: Various locations, Sweden.
Anticipated study end date: December 2013.
US2012/0202181A1 Maternal simulator
This patent application outlines a birth simulation device that can be attached to a real human and can be used as a teaching device for simulating pregnancy, birth and birth-related complications. The simulator includes a uterus that can be either in an atonic or contracted state and from which a baby manikin can be delivered. The patent also claims the device can simulate birth-related complications.
Gonzales Quinones P, Garvik TI, Lørup L, Ianke JP. Maternal simulator. 9 August 2012.
US2012/0202297A1 Gender determination method
This patent application relates to an easy-to-use, non-invasive fetal gender determination method and testing kit. The method outlined is based upon determining the difference in testosterone levels in the body fluids (serum, blood, urine or plasma) of a pregnant female carrying a male fetus compared with the levels in a woman carrying a female fetus.
Hendrickson CM, Merkle DL, Spurgeon J, Spurgeon G. Gender determination method. 9 August 2012.
US2012/0192873A1 Umbilical cord tab
This patent application describes the invention of a device and method for cleaning the umbilical cord stump and navel of an infant. The invention solves the issue of the need for a parent/carer to physically touch the umbilical stump and therefore minimises the risk of infection. The skin around the navel can also be protected from cleaning fluids while the umbilical stump is being cleaned.
Bachmann JE. Umbilical cord tab. 2 August 2012.
Colombian Constitutional Court reaffirms that the Procurador General de la Nación must provide accurate and truthful information on sexual and reproductive rights
Despite an increased commitment to protecting women's rights in Colombia in recent years, the Procurador General de la Nación and two deputies were found guilty by the Colombian Constitutional Court of violating their duties as public officers. The ruling, which was issued on 12 September 2012, states that the officials violated constitutional law by issuing documents to the public containing incorrect and biased information on sexual and reproductive rights and health care. Some of the inaccurate information distributed included that emergency contraception causes termination of pregnancy, that health-service personnel have the right to deny women access to lawful reproductive health services as a result of their moral or religious beliefs and that there is no right to legal safe termination of pregnancy in Colombia.