1. NASG for Relief Settings Consultation on Reproductive Health Technologies for Crises Settings PATH & Women's Commission for Refugee Women and Children May 13-14, 2008 Suellen Miller, CNM, PhD Associate PRofessor UCSF, Dept Ob/Gyn & Reproductive Sciences

2. Pneumatic AntiShock Garment

4. PASG Did not make statistically significant difference in mortality and morbidity for lower body trauma patients (all ages, all dxs.) in urban settings with trauma centers Use of PASG for obstetrical hemorrhage: –ONLY 6 cases reported –NO comparative trials

5. NASG Light-weight, reusable Lower body counter pressure Decreases bleeding Reverses shock May contribute to decreased morbidity and mortality

6. 3 way stretch neoprene (wet suit material) Industrial strength Velcro Foam pressure ball over uterus

10. THERAPEUTIC EFFECTS OF ANTISHOCK GARMENT Efficient, simple & safe circumferential counterpressure RESUSCITATION OF CENTRAL CIRCULATION Results in translocation of up to 30% of total blood volume from lower body to core REDUCES HEMORRHAGE IN LOWER BODY Decrease in arterial perfusion pressure to the uterus, comparable to ligation of the internal iliac arteries. Overcomes pressure in capillary and venous system (15-25 mm Hg.), reduction of transmural pressure, vessel radius and flow.

11. USES Stabilizes patient while evaluating, transporting, or preparing for definitive surgical treatment. Can be safely and comfortably used up to 48 hours. May arrest bleeding and avoid surgical intervention. May decrease need for or number of blood transfusions During delays, such as waiting for interventional radiology

12. NASG Obstetric Hemorrhage

13. What NASG Does NOT DO Does not avert the necessity for evaluation to identify cause of shock to manage fluid and blood replacement to provide appropriate therapy for coagulopathy

14. Little Experience with NASG 206: Egypt (results published) Results being analyzed 540: Egypt II 580: Nigeria 1126 women treated with the NASG to date

15. VariablePre (n= 158)NASG (n=206)P Value Median estimated blood loss at study entry 750.0 (750, 2000) 975.0 (500, 3000) <0.001 Median blood loss in drape 500 (0, 2400)250 (0, 900)<0.001 Severe morbidity & mortality 5 (3.2%)2 (1%)0.320 Egypt: 364 Women 50% lower median measured blood loss in the drape, 68% decrease in morbidity and mortality

16. Median Pulse Recovery Times from Kaplan-Meier Survival Analysis Median time from study entry to first pulse < 100 in minutes (95% confidence interval)* Study Group Pre- intervention (N=106) NASG (N=145) Pulse at admission < 120 150 minutes (117 – 183) 45 minutes (36-54) Pulse at admission >= 120* 240 minutes (161-319) 170 minutes (120-220) * Log Rank Test adjusted for pulse at admission = 21.20, p=0.000

17. Findings Promising Clinically promising: faster recovery, shorter time of oxygen deprivation, lower blood loss THAN standard treatment Statistically significant on PROXY indicators OUTCOMES OF INTEREST: Mortality and Morbidity, not statistically significant Lower quality design, PRE/POST

18. Lack of Evidence for Crisis Settings To date, these results have all been obtained at tertiary care facilities with access to surgery, blood and sufficient supplies, anesthesiologists, etc. –Currently testing whether application at a clinic prior to transfer will affect outcomes

19. Applicability for Relief Settings Easy to use Training for application, management and removal just a few hours Can stabilize patients for transport to a referral facility

20. Barriers to Use in Relief Settings Institutional capacity (tested in tertiary centers) –NASG is first aid - not definitive treatment –Facilities must be able to provide Oxygen Normal Saline Blood Uterotonics and other medicines Surgery/anesthesia –NASG buys time, but patients still need to be monitored, so adequate staffing, essential drugs and equipment are important Provider training and retraining is required, new staff must constantly be trained

21. Barriers cont. Referral protocols –Referral hospitals that will receive referred patients must first be trained and proficient –Patients need to be sent to the correct facility –If referral protocol is not correctly implemented, the patient’s greatest risk is improper removal of the NASG by untrained staff –Protocols for garment cleaning and return or exchange need to be established

22. Barriers cont. Community acceptance –Patient compliance varies by site –Patient education for life-threatening situations is difficult and problematic

23. Barriers cont. Care and maintenance –Highly correlated with the lifespan of the NASG –Adequate supply of clean water required –Not difficult, but must be done properly; not intuitive, needs training, re-training and support –Cleaning staff need to be trained to properly clean, fold, and store Time lost due to clean ones not available Time lost due to improper folding

24. NIH/GATES Collaboration: UCSF, WHO/RHR, CREP, UTH, UZ Randomized Cluster Trial Zambia and Zimbabwe Standard Treatment (uterotonics/IVs) and Application of NASG at midwifery-led peripheral clinics or Standard Treatment Transport to Tertiary Care Hospital where all women receive NASG Sample size large enough to demonstrate 50% decrease in M&M

25. Brees C, Hensleigh PA, Miller S, Pelligra R. (2004). A non-inflatable anti shock garment for obstetric hemorrhage. Int J Gynaecol Obstet, 87 (2), 119-124, 2004. *Miller, S, Hamza, S, Bray E, Gipson R, Nada, K, Fathalla, M, Mourad, M. et al. First Aid for Obstetrical Hemorrhage: The Pilot Study of the Non-pneumatic Anti-Shock Garment (NASG) in Egypt. British Journal of Obstet Gynaecol, 113(4): p. 424-9, 2006. Miller, S., Turan, JM, Ojengbede A, Ojengbede, O, Fathalla, M, Morhason-Bello, IO, Mourad, M, Galandanci, H, Hamza, S, Awaal, M, Akinwuntan, A, Mohammed AI, McDonough, L, Dau, K, Butrick, E, and Hensleigh, P. The Pilot Study of the Non- pneumatic Anti-Shock Garment (NASG) in Women with Severe Obstetric Hemorrhage: Combined Results from Egypt and Nigeria. Int J Gynaecol Obstet, 94(S3), ps43-s44. 2006 * Miller, S & Hensleigh, P. Non-pneumatic Anti-shock Garment for Obstetric Hemorrhage.Book Chapter, in International Federation of Obstetrics and Gynecology (FIGO) Book, Postpartum Hemorrhage: New Thoughts, New Approaches, Editors: C. B-lynch, A. LaLonde, L. West,. Sapiens Publications, UK. 2006 * Miller, S, Ojengbede A, Turan J, Ojengbede O, Butrick E, Hensleigh, P. Anti-Shock Garments for Obstetric Hemorrhage. Current Women’s Health Reviews, 3(1), 3-11, 2006. * Miller, S, Turan, JM, Dau, K, Fathalla M, Mourad M, Sutherland, T, Hamza, S. et al. Decreasing Maternal Mortality from Hypovolemic Shock in Low Resource Settings: the Non-pneumatic Anti-Shock Garment (NASG). Global Public Health Journal, 2(2);110-24, 2006.

26. Thank you….. Questions???