1. UPDATE OF NEW TECHNOLOGIES TO TREAT POSTPARTUM HAEMORRHAGE
Presented by
Dr. Sylvia Deganus

2. 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

3. PATH Courtesy Goudar, Eldavitch, Bellad, 2003 Pathfinder
Acknowledgements
PATH
Courtesy Goudar, Eldavitch, Bellad, 2003
Pathfinder

4. 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.

5. 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)
About 5% of women will loose more than 1000 mls of blood during normal vaginal delivery. ICD-10 Describes PPH as blood loss of more than 500ml for vaginal delivery and 750 mls for Cesarean section. Old methods for estimating blood loss include visual, gravimetric, collection into pans etc. Acid haematin techniques, spectrophometric, plasma volume changes.

6. THE BRASSS-V DRAPE A low cost calibrated plastic blood collection drape.

7. BRASSS-V DRAPE: Direct measurement of blood loss (PPH)
This was dev during a RCT to test oral use of misoprostol to reduce incidence of acute PPH in Belgaum, India. It was dev by the NICHD funded Global Network collaboratiive team. The name BRASSS is formed from thre first letters of the names of the seven collaborators who developed the drape. It has a callibrated funnelled collection pouch. Studies show that BRASSS-V is an accurate and practical tool to measure blood loss in the third stage.

8. Measuring Blood Loss in PPH
Blood Loss (n = 434)
Mean + SE
Range
Median
200
Mode
100
Acute PPH
57 (13.2 %)
Acute severe PPH
8 (1.8 %)
Points:
Most old studies do not have good data on incidence of PPH because measurement was not standard. A range of figures have been reported.
This is perhaps the best study in a rural community for measuring blood loss
Goudar, Eldavitch, Bellad, 2003

9. 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

10. 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 %.)
Easy to use
Can effectively be used in low resource settings
Safer alternative to uterine packing

11. Commercially Available Balloon Tamponades in Use
Sengstaken–Blakemore
$220 for two devices
Rusch hydrostatic
$77 (quoted £50)
Bakri
$250 per device
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:

12. 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
Main points
Desperation
Quality controls: what constitutes a clinically relevant feature / standards / feature mapping
Other promising technologies in the pipeline:

13. THE CONDOM TAMPONADE Water/NS UTERUS
Inflate Condom with water till no further bleeding is occuring (usually about mls )
syringe
Condom OR
Giving set
String
Foleys Catheter
Clean
water
Apply clamp to keep water within
Condom after inflation

14. The Condom Tamponade Emergency Pack
Bangladesh– cost of components adds up to $2.96. Gauze packs or sanitary napkins are used for vaginal packing after the condom catheter has been inserted, to keep in place

15. 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)

16. Steps in using the Condom Tamponade.. 2
5. Inflate condom with water or saline to about 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

17. 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.

18. 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) *.

19. 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.

20. 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

21. The B-Lynch Suture B-Lynch Suture #2
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,

22. B-Lynch Suture #3 Modifications of this procedure are also available:
Example Suture is “fixed” by taking bites through Myometrium at the fundus

23. 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 :

24. The Compression Sutures
Advantages :
Preserves future fertility and menstrual function
Simple and quick to perform
Disadvantages
Uterine wall ischaemia /Necrosis

25. 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

26. 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

27. Success rates of the new Technological measures in the management of PPH
Method
Number of Cases
Success Rates (%)
95% CI (%)
B-Lynch/compression sutures
108
91.7
84.9–95.5
Arterial embolization
193
90.7
85.7–94.0
Arterial ligation/pelvic devascularization
501
84.6
81.2–87.5
Uterine balloon tamponade
162
84.0
77.5–88.8
All these procedures effectively produce tamponade by compressing the uterus and apposing the anterior and posterior walls
They do not interefere with future mentruation or fertility.
There was no statistically significant difference between the four groups (P = 0.06).

28. 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).
Initial devices were developed in the 1990,s, anti-gravity suits in the Veitnam war 1942.,from MAST (Medical antishock trousers), PAST (Pneumatic antishock trousers). NASG is light weight, has no pumps, tubings etc,. Uses the elasticity of neoprene with velco fastners it can shunt about 500 to 1500 ml of blood into the central pool.

29. 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

30. 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

31. Two Zambia NASGs Used 50+ Times
It can be reused……… : A Logistic dream
Two Zambia NASGs Used 50+ Times

32. NASG : Experiences from Nigeria & India Courtesy Pathfinder 2008-2010
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

33. 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

34. 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

35. Availability of Skilled Staff Doctors Self Assessed Competency Levels in One District in Ghana
SKILLS/LEVEL OF COMPETENCE 1 2 3 4 5
Managing shock with IV fluids
30.8
69.2
Repair of Cervical Tear
Performing Bimanual uterine compression
7.7
15.4
46.2
Using Condom tamponade for PPH
23.1
Performing Manual removal of Placenta
Performing B-Lynch Suture
100
Performing cesarean Hysterectomy
38.5

36. Midwives self assessed competency levels at a District in Ghana
EMOC SKILL 1 2 3 4 5
Proportion of staff (%)
Managing shock with IV fluids
5.0
15.0
30.0
50.0
Using Oxytocin to Manage PPH
20.0
65.0
Using Misoprostol for PPH Management
25.0
Repair of Episiotomy and perineal tears
10.0
60.0
Repair of Cervical Tear
Performing Bimanual uterine compression
35.0
Using Condom tamponade for PPH
80.0
Performing Manual removal of Placenta

37. Promote Change

38. …questions?
Image courtesy of defeatpoverty.com

39. THANK YOU