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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

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Presentation Transcript
presentation outlines
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

Acknowledgements

PATH

Courtesy Goudar, Eldavitch, Bellad, 2003

Pathfinder

management challenges of obstetric bleeding
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
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, Spectrophometrictechnics and measuring plasma volume changes)

measuring blood loss in pph
Measuring Blood Loss in PPH

Goudar, Eldavitch, Bellad, 2003

advantages of brasss v
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
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
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;116:748-757

slide12

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

slide13

THE CONDOM TAMPONADE

Water/NS

UTERUS

Inflate Condom with water till no further bleeding is occuring (usually about 300-500 mls )

syringe

Condom

OR

Giving set

String

Foleys Catheter

Clean

water

Apply clamp to keep water within

Condom after inflation

preparing and using the condom tamponade e g protocol guide
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
Steps in using the Condom Tamponade.. 2

5. Inflate condom with water or saline to about 300- 400 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
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
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) *.
slide19

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
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
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
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
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
The Compression Sutures

Advantages :

  • Preserves future fertility and menstrual function
  • Simple and quick to perform

Disadvantages

  • Uterine wall ischaemia /Necrosis
selective artery embolisation
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 embolisation1
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
Success rates of the new Technological measures in the management of PPH

There was no statistically significant difference between the four groups (P = 0.06).

non pneumatic anti shock garment nasg
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
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
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
slide31

It can be reused……… : A Logistic dream

Two Zambia NASGsUsed 50+ Times

nasg experiences from nigeria india courtesy pathfinder 2008 2010
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
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
UPDATED STEPS IN THE MANAGEMENT OF SEVERE PPH

PREVENTION AMTSL

UTERINE MASSAGE / MORE OXYTOCICS

Establish Cause

TEARS

ATONY (90%)

COAGULOPATHY

RETAINED

PLACENTA

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
Availability of Skilled StaffDoctors Self Assessed Competency Levels in One District in Ghana
slide38

…questions?

Image courtesy of defeatpoverty.com