Transcript obstetric haemorrhage

Pneumatic Anti Shock Garment
London 24-26 October 2011
Prof Mohamed A
El Sheikh FRCOG
and Dr Duria Rayes
Pneumatic Anti Shock Garment
London 24-26 October 2011
Prof Mohamed A
El Sheikh FRCOG
The Millennium Development Goals
Eight Goals for 2015
1 Eradicate extreme poverty and hunger
2 Achieve universal primary education
3 Promote gender equality and empower women
4 Reduce child mortality
5 Improve maternal health
6 Combat HIV/AIDS, malaria and other diseases
7 Ensure environmental sustainability
8 Develop a global partnership for development
Maternal Mortality
• Every year, an estimated 529,000 women die
from complications of pregnancy and
childbirth;
• 99% of these deaths occur in developing
countries.
• For every woman who dies, there are 30
women who suffer a maternal morbidity and
10 who experience ‘near miss mortality’ (a
life threatening obstetric complication)
Postpartum haemorrhage (PPH),
• Defined as vaginal bleeding in excess of
500mL after vaginal delivery and in excess of
1000mL after caesarean delivery
• The most common cause of obstetric
haemorrhage.
• One of the five leading causes of maternal
mortality in developed and developing
countries,
• A WOMAN dies every 4 minutes from PPH
Maternal mortality due to PPH
 Many women in rural areas, where hospitals
may be days away, are transported over long
distances to the “nearest” hospital, and,
 if they survive the trip, often encounter
additional delays in receiving appropriate
treatment.
 Also, in areas that have limited resources, clinics
and hospitals might not have the staff or
supplies needed to save a woman's life.
Maternal mortality due to PPH
 When delays occur, a woman can bleed enough
to go into shock.
 Unless this is reversed, her vital organs,
including the kidney, heart, lungs and brain, can
be irreversibly damaged.
 A bleeding woman who develops hypovolaemic
shock from PPH can die within 2 hours.
 Women die waiting for treatment.
Maternal mortality due to PPH
TOO LATE ……. TOO LITTLE
Delay in transport
Too Little (IV fluids, oxytocics, BLOOD,
Clotting factors)
Too Late (PG, resuscitation - blood
replacement, decision for surgery + to get
senior surgeon & anaesthetist involved)
Obstetric Haemorrhage
 can be managed in developed countries with
uterotonic medications, blood transfusions, and
surgery,
 is often fatal in developing countries
 where a large percentage of births occur at home
 where there is limited access to high quality
Comprehensive Emergency Obstetric Care (CEmOC)
 New strategies or technologies that can reduce this
burden of disease will greatly contribute to improved
health of women, families, communities and nations
The Anti-Shock Garment (ASG)
• is a generic term for any compression device
that shunts blood from the extremities to the
core organs, heart, lung, and brain, thus
reversing shock.
• In the 1903 an inflatable pressure suit was
developed to decrease postural hypotension in
neurosurgical patients (George W Crile
• In the 1940s and after undergoing numerous
modifications, the suit was refined for use as an
anti-gravity suit (G-suit).
The Anti-Shock Garment (ASG)
Further modification led to its use in the
Vietnam War for resuscitating and stabilizing
soldiers with traumatic injuries before and
during transportation.
In the 1970s the G-suit was modified into a
half-suit which became known as MAST
(Military anti-shock trousers) or PASG
(Pneumatic Anti-Shock Garment).
THE MILITARY TROUSERS
The Anti-Shock Garment (ASG)
 In 1979, the PASG was useful for temporary
management of massive obstetric haemorrhage
in four women with ectopic pregnancies
awaiting surgery. (Hall and Marshall)
 During the 1980s the PASG garment was used by
emergency rescue services to stabilize patients
with shock due to lower body haemorrhage.
 In 1993, the PASG was used in the management
haemorrhage in two women with abdominal
pregnancies (Sandberg and Pelligra)
The Anti-Shock Garment (ASG)
In 1999, Bengt et al. its use as a temporary
measure before definitive radiological
intervention in two women with uterine
bleeding.
During the 1990s the PASG was added to the
American College of Obstetrics and
Gynaecology, making it part of the
recommended treatment for use by
obstetricians and gynaecologists in the USA.
Non-pneumatic Anti-Shock Garment
(NASG),
 From the 1970s, NASA/AMES developed a nonpneumatic version of the anti-shock garment.
 This was originally used for haemophiliac
children,
 but has since been developed into the garment
known as the Non-pneumatic Anti-Shock
Garment (NASG), which has been used for a
variety of indications since the mid 1970s.
Non-pneumatic Anti-Shock Garment
(NASG),
 In 2002 when Brees and Hensleigh introduced
the garment for obstetrical haemorrhage into a
hospital in Pakistan and reported on a case
series of its use.
 Miller and colleagues in Mexico, Egypt and
Nigeria have completed studies of the NASG
(also named the Life Wrap) for obstetric
haemorrhage in hospitals in these countries
with studies ongoing at primary health care
centres in Zambia and Zimbabwe.
The Non-Pneumatic Anti-Shock
garment (NASG)
 is a simple lightweight, relatively inexpensive
washable and reusable compression suit, comprising
five neoprene segments that close tightly with Velcro
around the legs, pelvis and abdomen
 designed to allow perineal access so that
examinations and vaginal procedures can be
performed without it being removed.
 The NASG reverses shock by returning blood to the
heart, lungs and brain enhancing organ perfusion
before definitive treatment is available.
 This restores the woman's consciousness, pulse and
blood pressure.
The Non-Pneumatic Anti-Shock
garment (NASG)
It is postulated that the NASG reverses the
hypotension by at least three different
mechanisms:
• By increasing peripheral vascular resistance,
• By a tamponade effect on intra-abdominal
bleeding and
• By auto transfusion of blood from the lower
extremities and abdomen to the head and
upper trunk.
The Non-Pneumatic Anti-Shock
garment (NASG)
 only applies 30–40 mmHg
 play an important role in overcoming delays that
contribute to unnecessary deaths from obstetric
haemorrhage.
 The NASG is NOT recommended for use with:
 a viable foetus,
 patients with mitral stenosis, congestive heart
failure, pulmonary hypertension,
 in clinical conditions where there could be bleeding
sites above the level of the diaphragm.
Non-pneumatic anti-shock garment (NASG) on
blood loss from obstetric haemorrhage
Research has been carried out in Egypt and
Nigeria and is ongoing in Zimbabwe and
Zambia
50% decrease in measured blood loss after
entry (250 Vs 500 ml) who were treated with
NASG compared to those treated with
standard protocol.
Source: Suellen Miller
 Promising results
 Significant reduction in blood loss and improved
resuscitation time
 Trend toward reduction in morbidity and mortality
 Additional research
 Continuing pre/post studies in Nigeria & Egypt
 Randomized Cluster Controlled Trial in Zambia and
Zimbabwe
Objective
To evaluate the feasibility, safety and
effectiveness of the non-pneumatic antishock garment for resuscitation and
haemostasis following obstetric haemorrhage
resulting in severe shock.
To determine whether the non-pneumatic
anti-shock garment (NASG) can improve
maternal outcome.
Design of the Study
A non-randomized preintervention/intervention study ???
Comparative study ????
Observational study ????
Randomised controlled study???
 Cluster randomised controlled study.
(This needs further discussion)
• SETTING: multicentre international study
Study Population
Entry criteria are:
• obstetric haemorrhage ( clinically estimated
as ≥750 mL)
• A clinical sign of shock (systolic blood
pressure <100 mm Hg or pulse >100 beats per
minute).
• (Exclusion criteria? )
Primary Outcomes
 Measured mean and median blood loss,
 Severe end-organ failure morbidity (renal
failure, pulmonary failure, cardiac failure, or
CNS dysfunctions),
Mortality,
Emergency hysterectomy.
(Others???)
METHODS
 All women who satisfy the criteria are admitted to
the study.
 The standard resuscitation measures were done.
 The NASG is then applied on the patient as soon as
there is clinical evidence of severe haemorrhage or
shock.
 Clinical observations include pulse, blood pressure
and respiratory rates every 15-30 minutes;
 oxygen saturation is obtained intermittently as
clinically indicated and
 a Foley’s catheter is inserted to determine the urine
output.
METHODS
 Fluid resuscitation included rapid saline infusion
of 1.5 times the estimated blood loss and
 blood transfusion when available.
 When the pulse and the blood pressure return
to baseline and the condition of the patient is
stable the NASG is removed in segments,
beginning at the ankles and sequentially
removing the panels upwards at15-min intervals
with observation for recurrent hypotension or
tachycardia.
Statistical Methods
statistical methods need to be reviewed?
 t tests and chi(2) tests.
Comparisons of outcomes are assessed with
rank sum tests, relative risks (RR) and 95%
confidence inter, number needed to treat for
benefit (NNTb), and multiple logistic
regression
METHODS
• In cluster randomized controlled trial the
methodology is different, that needs further
discussion (Zambia / Zimbabwe study as an
example; (currently ongoing study)
MILLENIUM DEVELOPMENT
MILLENIUM
DEVELOPMENT
GOALS
GOALS
THANK YOU
THANK YOU
Discussion
 Confirms larger study in Egypt 1
 NASG Group has better outcomes, despite
entering study in worse condition
 Limitations
 Small sample size
 No contemporary controls (pre/post)
 Groups were statistically significantly different in parity
 In some of these hospitals, a lack of blood and fluids
limits successful outcomes
1 Miller
S, Hamza S, Bray E, Lester F, Nada K, Gibson R, Fathalla M, Mourad M, Fathy A, Tuan J, Dau K, Nasshar I, Elshair I,
Hensleigh P. First aid for obstetric haemorrhage: the pilot study of the non-pneumatic anti-shock garment in Egypt. BJOG:
2006.
Rule of 30
& Shock Index

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30% blood loss >moderate shock
Pulse rate – increase >30 bpm
Respiratory rate >30/min
Systolic BP – drop by 30 mm Hg
Urinary output < 30 ml/hour
Haematocrit drop > 30% & to be kept at an absolute value of >
30
 Shock Index = Pulse rate / Systolic BP – Change by 30%
Normal = 0.5 to 0.7 : >0.9 indicates state of shock that needs
urgent resuscitation
PPH - Old problem – Innovative
Approaches
HAEMOSTASIS & Rule of 30
 PG potentiates the action of oxytocin
 Anti-shock Garment
 Tamponade test - Therapeutic & Diagnostic
 Uterine Compression Sutures
 Body weight – Blood volume & Hb%
 ‘Wash Out’ phenomenon - fibrinogen/ r-Factor VII
 Severe Shock & Golden Hour - Definitive Surgery