DOI: 10.1111/j.1471-0528.2011.03142.

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International guidelines, patents and trials

Womens healthwhats new worldwide

International guidelines/reports
Family planning and reproductive health
indicators database
This resource developed by Measure Evaluation and Reproductive Health Project,
which is funded by the United States
Agency for International Development
(USAID), provides access to a comprehensive list of the most widely used indicators
for evaluating family planning and reproductive health programmes in low-resource
countries. The aim of this database is to
provide a clinically useful set of family
planning and reproductive health indicators
for evaluation of such programmes. It will
also allow consistency in data collection
and allow data obtained from different
programmes in different countries to be
compared directly. Organised into three
sections the resource contains a detailed
overview of the database and how to navigate it, a list of cross-cutting indicators
(including policy, operations research,
management, training and service delivery
indicators) and third a list of specific indicators (including fertility, healthy timing
and spacing of pregnancy, safe motherhood, post-abortion care, obstetric fistula
and malaria in pregnancy indicators) that
can all be used to evaluate different areas of
family planning and reproductive health
services provision in low-resource settings.
Links are also provided to other online
resources including handbooks and guides.
It will be a useful resource for healthcare
administrators, managers, social science
researchers, students and health workers for
evaluating the progress and effectiveness of
their reproductive health programmes.
www.cpc.unc.edu/measure/prh/rh_indica
tors

The Millennium Development Goals

report 2011
Published by the United Nations, this
report reviews the progress made over the
past 10 years since world leaders launched
the Millennium Declaration and the
Millennium Development Goal (MDG)

framework. The report highlights that

progress has been made in many areas as a
result of economic growth in some developing countries, targeted interventions to
address specific key issues and increased
funding allowing for the expansion of
programmes and services to address the
MDGs. Significant progress has been made
in seven key areas: decline of poverty in
many countries; reduction in deaths from
malaria; effective HIV prevention and
treatment programmes; effective strategies
targeting tuberculosis; increases in provision of and access to education; access to
clean drinking water; reduction in child
mortality. However, this report emphasises
that despite real progress having been
made, many programmes and interventions
have failed to reach the most vulnerable
members of society and the report calls for
renewed efforts targeting the most vulnerable to ensure that the MDGs can be
achieved by 2015.
www.un.org/millenniumgoals/11_MDG%
20Report_EN.pdf

The state of the worlds midwifery 2011:

delivering health, saving lives
This extremely comprehensive report from
the United Nations Population Fund (UNFPA) provides a global view of the current
state of midwifery provision in the 58
countries around the world representing
91% of global maternal deaths. The report
has been compiled in response to the
Global Call to Action issued at the Symposium on Strengthening Midwifery at
Women Deliver, held in Washington in June
2010. Chapters discussing the midwifery
workforce, education, service delivery and
organisation and access to midwifery care
are included. Individual country profiles
provide a detailed insight into workforce
issues, midwifery education provision, regulation, professional associations, policies
and services. Three key areas that require
addressing have been identified: a triple gap
exists in terms of midwifery competencies,
coverage and access; insufficient focus on

2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2011 RCOG

quality of care in midwifery education, regulations and associations; disjointed policies

and lack of access to strategic intelligence
or evidence for action information. Challenges to providing quality midwifery services are identified in the report and
solutions are outlined to help strengthen
the provision of midwifery services
throughout the world. The report also
urges governments to recognise midwifery
as a distinct profession that is core to the
delivery of maternal and newborn services
and also to ensure that regulatory bodies
are in place to monitor quality of provision
of care and the delivery of obstetric education.
www.unfpa.org/sowmy/resources/docs/main_
report/en_SOWMR_Full.pdf

Progress of the worlds women: in

pursuit of justice 201112
This United Nations report highlights progress made around the world in advancing
womens rights with particular reference to
legal issues and justice systems. Part I of
the report introduces womens justice and
outlines groundbreaking legal cases.
Comprehensive case studies from Nepal,
Bulgaria, Ecuador and Liberia are also
provided. Part II focuses upon justice for
women and outlines how this impacts upon
the MDGs. The report provides ten key
recommendations for advancing the
rights of women in countries around the
world: support womens legal organisations;
support specific services to reduce attrition
in the justice chain; implement gendersensitive law reforms; introduce quotas to
increase the number of women legislators;
employ women in law enforcement activities; train judges effectively and monitor
all legal decisions; increase womens access
to courts both during and after conflicts; ensure that gender-responsive reparations programmes are introduced; ensure
adequate funding for womens access to
justice; ensure that gender equality is a key
element within the MDGs. The report
states that although equality between

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International guidelines, patents and trials

women and men is guaranteed in the constitutions of 139 countries and territories,
inadequate laws, poor enforcement and vast
implementation gaps make these guarantees
hollow promises.
http://progress.unwomen.org/pdfs/ENReport-Progress.pdf

Clinical trial recruitment

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

How sweet is it? Measurement of glucose

in epidural and spinal fluid
http://clinicaltrials.gov/ct2/show/NCT01391702
In women who require anaesthesia for
caesarean section following labour, this is
usually done by topping up the epidural
anaesthetic inserted during the labour.
Epidural anaesthetic can sometimes be ineffective for caesarean sections. In such cases,
the anaesthetist will administer a spinal
anaesthetic following a failed epidural anaesthetic in labour. During the administration
of the spinal anaesthetic, the anaesthetist
relies on the presence of the aspiration of
cerebrospinal fluid (CSF) to be sure that the
tip of the spinal needle is correctly placed
before injecting the local anaesthetic. The
presence of such an aspirate for CSF can
sometimes be confused with the aspiration
of fluid within the epidural space from the
epidural infusion or injection during the
labour. This observational study aims to
investigate whether, in women requiring a
spinal anaesthetic before caesarean section
and following a failed epidural anaesthetic
during labour, the use of a bedside glucose
monitor to measure the level of glucose in
the aspirate can help the anaesthesiologist
to differentiate whether the tip of the spinal
needle is in the epidural or subarachnoid
space.
Inclusion criteria: Healthy women
(American Society of Anesthesiologists 1 or
2 classification) with a pre-existing epidural; singleton pregnancy; age 19 years
or older; understand written and oral English.
Primary outcome measure: To confirm
that the glucose meter is a feasible and
accurate bedside method to detect glucose
in epidural aspirate and to use glucose to
differentiate CSF from epidural aspirate in
women with epidural fluid from pre-existing in situ epidural catheters.

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Secondary outcome measures: Influence

of other factors on epidural glucose level.
Estimated study sample size: 200.
Trial site: British Columbia, Canada.
Anticipated trial end date: December
2011.

Evaluation of the low-molecular-weight

heparin thromboprophylaxis in
pregnancy
http://clinicaltrials.gov/ct2/show/NCT01394107
This observational study aims to determine, in pregnant women with a high risk
of thromboembolism immediately before
birth, the effect of the administration of a
standard dose of thromboprophylactic lowmolecular-weight heparin (LMWH) on the
coagulation indices over a period of
24 hours after administration. Thrombelastography and measurement of antiXa and
thrombin generation time (TGT) activity
will be performed. The possible influence
of LMWH prophylaxis on the risk of spinal
haematoma during neuraxial analgesia for
caesarean section will also be studied.
Inclusion criteria: Pregnant women
undergoing planned caesarean section; 39
40 weeks of gestation; aged between 18 and
40 years.
Primary outcome measure: Effect of
standard prophylactic dose of LMWH on
coagulation indices in pregnant women.
Secondary outcome measures: Evaluation
of the possible influence of LMWH on the
potential risk of spinal haematoma development during neuraxial blockade in pregnancy.
Estimated study sample size: Fifty
women with uncomplicated pregnancy
undergoing elective caesarean section and
50 healthy women undergoing elective surgery other than for oncology or inflammatory indications without known risk factors
for coagulation disorders as the control
group.
Trial site: Prague, Czech Republic.
Anticipated trial end date: December
2013.

GYNECARE PROSIMA* procedure

versus modified total pelvic floor
reconstructive surgery for uterine
prolapse stage III
http://clinicaltrials.gov/ct2/show/NCT01396109
This non-randomised study aims to
establish the effectiveness and safety, in
women with uterine prolapse, of GYNECARE PROSIMA* pelvic floor repair system

concurrently with transvaginal hysterectomy

when compared with modified total pelvic
floor reconstructive surgery with mesh
undertaken with concurrent transvaginal
hysterectomy. Women will be followed up
for 3 years after surgery and evaluation will
cover stage of prolapse before and after surgery, patient satisfaction, quality of life, sexual function and perioperative complication
rates.
Inclusion criteria: Candidates with symptomatic uterine prolapse of ICS POP-Q
Stage III (with any degree of vaginal prolapse), suitable for surgical repair; vaginal
hysterectomy will be performed concurrently; without stress urinary incontinence
or occult stress urinary incontinence with
no need of mid-urethral sling procedures
for incontinence to be performed; age
60 years; agrees to participate in the study,
including completion of all study-related
procedures, evaluations and questionnaires,
and documents this agreement by signing
the Ethics Committee/Institute Review
Board approved informed consent.
Primary outcome measure: Anatomical
improvement according to Pelvic Organ
Prolapse Questionnaire (POP-Q) score at
4 weeks, 6, 12 months, 2 and 3 years postsurgery.
Secondary outcome measures: Hospital
data including operative time, estimated
blood loss, length of stay, maximum temperature, time of voiding recovery; pain
score measured using a Visual Analogue
Scale; presence/absence of complications
(composite score); change from baseline in
Pelvic Floor Incontinence Questionnaire
(PFIQ)-7 scores; in women sexually active
at baseline, assessment of sexual function
using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12
(mean scores and change from baseline);
womans global impression assessed on a
five-point Likert scale; presence/absence of
complications (composite score).
Estimated study sample size: 200.
Trial site: Various locations in China.
Anticipated trial end date: March 2016.

Search for predictors of therapeutic

response in ovarian carcinoma (miRSa)
http://clinicaltrials.gov/ct2/show/NCT01391351
This study aims to define the profiles of
mitochondrial RNA expression of serum
polymorphisms and to determine differences in the profiles of two different patient
populations, those with or without cancer

2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2011 RCOG

International guidelines, patents and trials

recurrence 6 months after completion of

chemotherapy. It is hoped that the differences in profiles can be used to predict
chemotherapy response in women with carcinoma of the ovary, fallopian tube or
advanced serous type peritoneal carcinoma.
Inclusion criteria: Women with cancer of
the ovary, peritoneum or of the fallopian
tube; stage III or IV; cancer of serous histology; women should receive treatment
with Taxol and Carboplatin chemotherapy;
women who have signed informed consent;
women over the age of 18 years.
Primary outcome measure: Search for
predictors of response to chemotherapy.
Secondary outcome measures: Profiling
mitochondrial RNA expression; study of
changes in serum mitochondrial RNA
expression.
Estimated study sample size: 100.
Trial site: Various locations in France.
Anticipated trial end date: March 2014.

Flaxseed lignin for polycystic ovary

syndrome
http://clinicaltrials.gov/ct2/show/NCT01396369
This prospective pilot randomised study
aims to assess the effects of flaxseed supplementation (with Brevail) on hormonal lipid
metabolism balance in women with polycystic ovary syndrome (PCOS).
Inclusion criteria: Women aged 18
40 years; diagnosis of PCOS by menstrual
irregularity (fewer than nine menses annually/interval over 40 days), FerrimanGalleway score >8, and/or hyperandrogenaemia
defined as total testosterone >80 ng/dl or
bioavailable testosterone >8.4 ng/dl; mentally competent.
Primary outcome measure: To assess
changes of testosterone levels and hirsutism.
Secondary outcome measures: To assess
lipid profile and estrogen levels.
Trial site: Kansas, USA.
Anticipated trial end date: June 2013.

Patent news
Patent applications
US 7964189 (B1) Nutritional supplements
for women desiring to become pregnant, and
pregnant and nursing women. This US patent application outlines a unique nutritional supplement formulation that is
targeted at women planning pregnancy,
those who are already pregnant and those
who are breastfeeding. The formulation,
which is in tablet form, contains, among
many other nutrients, vitamin A, vitamin
D3, a lycopene-containing material, coenzyme Q10, docosahexaenoic acid, magnesium and selenium. It is anticipated that
this supplement will treat common deficiencies in the diets of many women before
conception, during the antenatal period
and while breastfeeding.
This application claims priority from US
Provisional Application Ser. No. 60/
995,065, filed 25 September 2007 and US
Provisional Application Ser. No. 61/
128,823, filed 27 May 2008.
Morrison, J.C., Greathouse K.R. Nutritional supplements for women desiring to
become pregnant, and pregnant and nursing women. 21 June 2011.
http://worldwide.espacenet.com/publication
Details/biblio?DB=EPODOC&II=14&adjacent=
true&locale=en_EP&FT=D&date=20110621&
CC=US&NR=7964189B1&KC=B1
US 2011178365 (A1) Surgical system for
supporting pelvic anatomy. This patent
application proposes a surgical implant and
a method of insertion for treating urinary
incontinence in women that consists of a
sling that passes under the urethra and provides a support by occluding the mid-urethra to improve symptoms of incontinence.
The sling is inserted through the surgical

incision using a handle containing the sling

with two curved needles placed at each end
of the sling that can be manipulated by the
handle to ensure that the sling is placed
correctly.
Browning, J. Surgical system for supporting pelvic anatomy. 21 July 2011.
http://worldwide.espacenet.com/publication
Details/biblio?DB=EPODOC&II=2&adjacent=
true&locale=en_EP&FT=D&date=20110721&
CC=US&NR=2011178365A1&KC=A1

Legal matters
The birth of donor offspring rights in the
USA?
This bionews comment reports that a new
law recognising the rights of donor-conceived individuals came into force in the
US state of Washington in July 2011. The
law means that everyone who donates
gametes to a fertility centre within Washington State will be required to provide
information identifying themselves and
details of their medical history. Washington
is the first US state to introduce such laws
but other countries around the world
including Sweden, New Zealand, the Netherlands, Norway, Switzerland and the UK
have already done so. The law states, however, that the donor can still veto disclosure
to prevent the fertility clinic from revealing
his or her identifying informationbut the
donor offspring will still be entitled to their
anonymised medical history.
www.bionews.org.uk/page_97446.asp?dinfo=
qUSflJrqJ5EapBGJFP2isrvP j

Shona Kirtley
Patrick Chien

Shona Kirtley, Womens Health Researcher. Patrick Chien, Consultant Obstetrician and Gynaecologist, Ninewells Hospital, Dundee, UK.

2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2011 RCOG

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