UPDATE OF NEW TECHNOLOGIES TO
TREAT POSTPARTUM HAEMORRHAGE
Presented by
Dr. Sylvia Deganus
Presentation Outlines
• The PPH Problem and Management
Challenges
• The New Technologies
–
–
–
–
Measuring Blood Loss
Balloon Tamponade
Anti-shock Garments
New Intra –Operative Surgical Techniques
• Advancing the New Technologies
• Questions/Comments
Acknowledgements
1. PATH
2. Courtesy Goudar, Eldavitch, Bellad, 2003
3. Pathfinder
Management Challenges of Obstetric
Bleeding
• It accounts for more maternal deaths than any other cause (about
25%) . More than half occur within 24 hours of childbirth.
• It is difficult to predict who will experience PPH on the basis of
risk factors.
• Recognizing promptly the emergency can sometimes be difficult
as blood loss is difficult to measure accurately.
• The estimated time to death from start of a bleeding complication
is often very short due to rapidity of blood loss and therefore
delays can be “costly”.
• Rapid, Aggressive, Timely and Skilled interventions action are
critical for survival.
Measuring Blood Loss
A key step to EFFECTIVE TREATMENT…..
• The Diagnosis of PPH is based on the amount of blood loss
(>500ml). Underestimation leads to delayed intervention.
• Visual estimated amounts of blood loss are notoriously far from
accurate by as much as 30-50%: especially for very large amounts.
– In one study the incidence of PPH by visual estimation were 5.7% (500ml) and
0.44% (1000ml) whereas direct measurement showed the true incidences to be
27.6 and 3.51% respectively.
• Old methods for estimating blood loss more accurately tend to be
complex.
(They include weighing soaked clothes and pads, collection into pans etc.,
Acid haematin techniques, Spectrophometric technics and measuring
plasma volume changes)
THE BRASSS-V DRAPE
A low cost calibrated plastic
blood collection drape.
BRASSS-V DRAPE:
Direct measurement of blood loss (PPH)
Measuring Blood Loss in PPH
Blood Loss (n = 434)
Mean + SE
265.18 +
10.95
Range
20 - 1600
Median
200
Mode
100
Acute PPH
Goudar, Eldavitch, Bellad, 2003
57 (13.2
%)
Acute severe 8 (1.8
PPH
%)
Advantages of Brasss-V
•
•
•
•
•
•
Simple and practical
Low cost: ( Plastic)
Accurate:
Objective
Can be used in a wide range of settings
Provides a hygienic delivery surface
Stopping the Bleeding:
Balloon Tamponade
• A balloon (inflated with saline/water) exerts pressure to
stop bleeding from within the uterus in 5-15 mins.
• Is very effective (≥85%) when uterotonics fail. Can prevent
need for laparotomy and hysterectomy. (Reported success rates
for the control and management of PPH with uterine tamponade are
quite high and range between 70-100%.)
• Easy to use
• Can effectively be used in low resource settings
• Safer alternative to uterine packing
Commercially Available Balloon
Tamponades in Use
Sengstaken–Blakemore
$220 for two devices
Bakri
$250 per device
Rusch hydrostatic
$77 (quoted £50)
BT-CATH
$200 per device
These commercially available devices are prohibitively expensive
Source: Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG 2009;116:748-757
The Innovative Condom Tamponade Unit
A condom still saves lives even during Childbirth!
Developed in Bangladesh
by Ashkter and Team
The Condom /Catheters Unit
can be assembled in a few
minutes and cost of
components is ≤ U.S.$5
THE CONDOM TAMPONADE
Water/NS
UTERUS
Inflate Condom with
water till no further
bleeding is occuring
(usually about 300500 mls )
Condom
String
syringe
Giving set
OR
Foleys Catheter
Apply clamp to keep water within
Condom after inflation
Clean
water
The Condom Tamponade Emergency Pack
Preparing and using the Condom Tamponade
E.g. Protocol Guide
1. Place condom over balloon end of Foleys catheter
2. Using suture / string tie lower end of condom snugly below
level of the balloon as shown. Tie should be tight enough to
prevent leakage of water but should not strangulate catheter
and prevent inflow of water into condom. Check for leakage by
inflating ballon with about 20cc water.
3. Using an aseptic technique place the condom end high into
uterine cavity by digital manipulation or with aid of speculum
and forceps
4. Inflate CT by connecting open/outlet end of catheter to giving
set connected to infusion bag or use clean water with aid of
large syringe. ( Will need to cut the giving set at level of yellow
rubber to enable it fit into catheter)
Steps in using the Condom Tamponade.. 2
5. Inflate condom with water or saline to about 300400 mls (or to amount at which no further bleeding
is observed).
6. Clamp catheter when desired volume is achieved
and bleeding is controlled.
7. Maintain In-situ for 6-12 hours if bleeding controlled
and patient is stable.
8. Give Broad spectrum antibiotic cover
9. Continue to monitor patient closely, resuscitate
and/or treat shock necessary
Steps in Using the Condom tamponade….3
10. When patient is stable ( after 6 hours) slowly deflate
condom by letting out 50 mls of water/saline every hour.
11. Re-inflate to previous level if bleeding reoccurs whilst
deflating.
12. CT may be kept in place for up to 24 hours
13. If Bleeding is not controlled within 15 mins of initial
insertion of CT abandon procedure and seek surgical
intervention immediately.
Contraindications To Use
When should we not use the balloon?
• Arterial bleeding requiring exploration and ligation or
angiographic embolization.
• Cases indicating hysterectomy.
• Where uterine rupture is suspected
• Cervical cancer.
• Disseminated Intravascular Coagulation (DIC) *.
Key Issues: In expanding access of Balloon
Tamponade to low-resource settings
• Currently available commercial devices are very
expensive; cost ≥ US$100.
• Only one device is specifically designed for the uterine
cavity — the Bakri balloon (Cook).
• More data are needed to guide proper use and
understand failures.
• An improved condom catheter could probably be
made for less than US$10.
New Intra-Operative Surgical
Techniques
A variety of new intra-operative techniques are now
available to effectively control bleeding from the uterus:
They either act to produce tamponade by compressing the
uterus and apposing its anterior and posterior walls or to
effectively reduce blood flow to the uterus. These
techniques include:
• Uterine Compression sutures :e.g.
– B-Lynch Brace Sutures
– Cho Sutures
– Square sutures
• Arterial ligation/pelvic devascularization
• Selective Arterial embolization (Uterine Artery)
• Use of Topical Haemostatic agents
The B-Lynch Suture
Step 1: Using Absorbale arge suture.
In-out-over…In-out-over…In-out-tie
B-Lynch Suture #2
Courtesy: Lynch BC, Coker A, Laval AH et al. The B_Lynch technique for control of Masive PPH,
An Alternative to Hysterectomy. Five Cases Reported. Br. J. Obstet Gynecol 1997, 104 327-376
B-Lynch Suture #3
Modifications of this
procedure are also
available:
Example Suture is “fixed”
by taking bites through
Myometrium at the fundus
UTERINE COMPRESSION SUTURES
• SQUARE
VERTICAL
A Straight needle is passed anterior to
posterior and passed over fundus
and ligated anteriorly.
Multiple square sutures are
Passed intramurally and tied at
Various points.
Cho JH, Jun HS, Lee CN: Haemostatic Suturing Technique For uterine Bleeding during Cesarean
Section delivery. Obstet Gynecol 200 0 96:129-131
The Compression Sutures
Advantages :
• Preserves future fertility and menstrual
function
• Simple and quick to perform
Disadvantages
• Uterine wall ischaemia /Necrosis
Selective Artery Embolisation
• Evolved from other angiograpic embolisation
techniques ( Since 30 Years)
• Gelatin Sponges are injected into the bleeding
vessel until stasis of flow in target vessel is
achieved. Acess is gained via femorals to
internal iliac and subsequently the uterine
arteries
Selective Artery Embolisation
Advantages
Preserves Fertility
Useful in Haemorrhage associated with Placenta praevia
Disadvantages
• Requires 24hr availability of radiological expertise.
• Patients must be stable
• Complications include: Necrosis of uterine wall,
contrast adverse effects, local haematoma formation
Success rates of the new Technological
measures in the management of PPH
Method
B-Lynch/compression
sutures
Arterial embolization
Number of Success
95% CI
Cases
Rates (%) (%)
108
91.7
84.9–95.5
193
90.7
85.7–94.0
Arterial ligation/pelvic
501
devascularization
Uterine balloon tamponade 162
84.6
81.2–87.5
84.0
77.5–88.8
There was no statistically significant difference between the four groups (P = 0.06).
Non-Pneumatic Anti-Shock Garment
(NASG)
• NASG is a simple device that
counteracts shock and decreases
blood loss by applying direct
counter pressure to the lower
parts of the body.
• Developed by NASA 20+ yrs ago
• Useful as a first aid tool that
Keeps woman alive during
prolonged transportation to reach
help (CEOC).
NASG - Non-pneumatic Anti-shock Garment
• Physiology – shunts blood to vital
organs (anti-shock)
• During delays, provides up to 48hrs
stability
• Neoprene and Velcro
• In 2008 growing clinical evidence
for PPH use (UCSF)
• Ongoing demonstrations in
India and Nigeria (Pathfinder)
• Expensive, poor quality controls
• In 1991 FDA cleared medical device
Advantages
• It can very easily and quickly applied.
Application requires about 2 mins
• Can be used by persons with minimal
training
• Within 2-5 minutes of application most
patients with severe shock regain
consciousness and vital signs begin to
stabilize
• The Non Pneumatic Garment is less
expensive and simpler than predecessors
• It also has less danger of excessive
pressures due to overinflation
It can be reused……… : A Logistic dream
Two Zambia NASGs
Used 50+ Times
NASG : Experiences from Nigeria & India
Courtesy Pathfinder 2008-2010
NIGERIA
• Garment used for stabilization while
blood donors can be found.
– 220 garments
– 963 uses
– 52 facilities (most uses come
from the original 42)
– Most severe cases of PPH are
from referrals – home or other
clinics
Challenges
• Cleaning :Lack of clarity around bleach
dilutions and rigor regarding time in
bleach solution
•
Extra large sizes needed
– Two documented cases of women
dying because garments did not fit
INDIA
•
Garment used for triage and transport
between facilities
– 131 garments
– 63 uses
Challenges
• There are people related issues
– Reluctance to use
– Cultural discrimination against different
castes and poor
• Demand was being throttled back because of
inadequate supply.
• Smaller sizes were needed in northern states
where women generally have lower BMIs
Advancing these new Technologies….
• Need for further research to Strenghten
evidence for their use and promotion
(Systematic reviews, RCT,
• They will complement already existing
procedures.
• They will work Best….. Where facilities are
prepared:, EMONC infrastucture and skills.
• There is yawning need to disseminate
Knowledge , Skills and Availablity of these
new Technologies
UPDATED STEPS IN THE MANAGEMENT OF SEVERE PPH
PREVENTION AMTSL
UTERINE MASSAGE / MORE OXYTOCICS
Establish Cause
TEARS
RETAINED
PLACENTA
ATONY (90%)
COAGULOPATHY
BIMANUAL COMPRESSION / AORTIC COMPRESSION /ANTI-SHOCK GARMENT
HYDROSTATIC CONDOM TAMPONADE
SURGERY
COMPRESSION SUTURING; B-LYNCH PROCEDURE
LIGATION OF UTERINE & OVARIAN ARTERIES
HYSTERECTOMY
Availability of Skilled Staff
Doctors Self Assessed Competency Levels in One
District in Ghana
SKILLS/LEVEL OF COMPETENCE
0
1
2
3
4
5
Managing shock with IV fluids
30.8 69.2
Repair of Cervical Tear
30.8 69.2
Performing Bimanual uterine
7.7
15.4 46.2 30.8
compression
Using Condom tamponade for PPH
23.1
46.2
15.4 15.4
Performing Manual removal of Placenta
30.8 69.2
Performing B-Lynch Suture
100
Performing cesarean Hysterectomy
15.4 23.1
23.1 38.5
Midwives self assessed competency levels at a
District in Ghana
EMOC SKILL
0
1
2
3
4
5
Proportion of staff (%)
Managing shock with IV fluids
Using Oxytocin to Manage PPH
Using Misoprostol for PPH
Management
Repair of Episiotomy and perineal tears
Repair of Cervical Tear
Performing Bimanual uterine
compression
Using Condom tamponade for PPH
Performing Manual removal of
Placenta
5.0
5.0 5.0
50.0 5.0
15.0
5.0
5.0
30.0 50.0
20.0 65.0
15.0 25.0
5.0 10.0 5.0
65.0 25.0 5.0
35.0 15.0 25.0
20.0 60.0
5.0
10.0 15.0
80.0 15.0
30.0 10.0 20.0
5.0
20.0 20.0
Promote Change
…questions?
Image courtesy of defeatpoverty.com
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