UPDATE OF NEW TECHNOLOGIES TO TREAT POSTPARTUM HAEMORRHAGE

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 (>500 ml). 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% (500 ml) and 0. 44% (1000 ml) 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) Goudar, Eldavitch, Bellad, 2003 Mean + SE 265. 18 + 10. 95 Range 20 - 1600 Median 200 Mode 100 Acute PPH 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 20 cc 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-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 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 24 hr 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 48 hrs 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%) COAGULOPATH Y 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 Performing Manual removal of Placenta 30. 8 69. 2 Performing B-Lynch Suture 100 Performing cesarean Hysterectomy 15. 4 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 50. 0 5. 0 15. 0 30. 0 50. 0 20. 0 65. 0 15. 0 25. 0 10. 0 5. 0 65. 0 25. 0 35. 0 15. 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

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