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, PhDAssociate PRofessor

UCSF, Dept Ob/Gyn & Reproductive Sciences

Pneumatic AntiShock Garment

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

NASG

• Light-weight, reusable

• Lower body counter pressure

• Decreases bleeding• Reverses shock• May contribute to

decreased morbidity and mortality

3 way stretch neoprene (wet suit material) Industrial strength VelcroFoam pressure ball over uterus

http://mail.google.com/mail/?view=att&disp=inline&attid=0.3&th=10aec598bd01713f

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.

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

NASG

Obstetric Hemorrhage

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

Little Experience with NASG

• 206: Egypt (results published)

• Results being analyzed

• 540: Egypt II

• 580: Nigeria

• 1126 women treated with the NASG to date

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) <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

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

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

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

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

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

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

Barriers cont.• Community acceptance

– Patient compliance varies by site– Patient education for life-threatening situations is difficult

and problematic

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

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

• 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.

• Thank you…..

• Questions???