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. Obstetric
Hemorrhage
NASG

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. Egypt: 364 Women
Variable
Pre (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)
Severe morbidity & mortality
5 (3.2%)
2 (1%)
0.320
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 ( )
170 minutes ( )
Pre-intervention (N=106)
NASG
(N=145)
Study Group
* 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)
Brees C, Hensleigh PA, Miller S, Pelligra R. (2004). A non-inflatable anti shock garment for obstetric hemorrhage. Int J Gynaecol Obstet, 87 (2), , 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 , 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-s
* 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???