NASG: Updates on Clinical Trial Results, Cost Effectiveness, and Global Guidelines

1. NASG: Updates on Clinical Trial Results, Cost Effectiveness, and Global Guidelines Professor Suellen Miller University of California, San Francisco Dept. Obs/Gyn & Reproductive Sciences Director, Safe Motherhood Program

2. What is the NASG?

3. Mechanism of Action DECOMPENSATORY SHOCK:the heart, lungs and brain are deprived of oxygen as blood accumulates in the lower part of the body OBSTETRIC HEMORRHAGE:blood also leaves the body through the vagina or pools in the retroperitoneal area Circumferential compression of the abdomen and legs reduces the volume of blood in the compressed areas, while expanding the central circulation, reversing shock The radius of a blood vessel is decreased, blood flow is decreased

4. NASG’s Unique Role in Obstetric Hemorrhage and Hypovolemic Shock • Used with hemorrhage therapies, uterotonics, massage, vaginal procedures, even surgeries • Does not compete with other approaches: Not an either or situation, first-aid device that buys time • A technology that can be used when patient with uterine atony does not respond to uterotonics AND • Effective for ALL obstetric hemorrhage: rupture, lacerations, ectopic • Only technology that reverses shock, until blood transfusions • Can be used with balloon tamponade to reverse shock

5. Countries Using NASGs

6. Clinical Trials: Tertiary Level • 5 peer-reviewed studies: 4 pre-post design, 1 (India) contemporaneous use • 3,651 women: Severe OH (>1000 mL) with clinical sxs of shock • 1614 (45.3%), standard care, 1947, 54.7% standard care + NASG • Sub-analysis of Severe Shock • (1227 MAP < 60 mm HG, 594, std care; 633, 51.6% std care + NASG) • Meta-analytic Techniques to pool all data

7. Outcomes: NASG Tertiary Level All Women • OR 0.62, 95% CI, 0.44-0.86 • 38% reduced odds of mortality For Women in more severe shock (MAP <60 mmHG) • OR: 0.41, 95% CI, 0.20 – 0.84 • 59% reduced odds of mortality • (decreased blood loss, reduced anemia at discharge, and faster recovery from shock)

8. Clinical Trials: Primary Level • Zambia and Zimbabwe, 2007-2012 • 880 women transported from PHCs, midwifery directed, no blood/surgery • Clinics randomized to standard care vs. standard care plus NASG before transport for hypovolemic shock • 38 clinics, 5 tertiary facilities • OUTCOMES: Mortality and Time to Recovery of Shock • Similar in magnitude of effect and trend of the Tertiary Facilities

9. Safety • > 5500 documented cases • NO REPORTS of any safety issues • NO INCREASE of side effects minor or major due to use of NASG

10. CEA: Outcomes of 1440 Women in Nigeria and Egypt • Using cost of old, expensive NASG • Use in Egypt: COST SAVINGS (~ 9,000) • Use in Nigeria: Highly Cost Effective, $3.00/DALY averted Using newer, BlueFuzion Price • Saved Egypt another $1,000 (>$10,000) • Decreased Costs in Nigeria, $1.78/DALY averted WHO calls any intervention that reduces DALY at < = GDP is “highly cost effective”

11. Hemorrhage Etiologies: UCSF

12. WHO, FIGO, GLOWM Recommendations • Based on safety, decreased blood loss, reduced time to shock recovery, and decreased mortality • WHO: 2012, Guidelines and 2013, “Highlights” • Examine national guidelines to ensure NASG included • Examine training curricula to ensure providers trained in NASG use (pre-service and in-service) • Procure NASGs • FIGO, 2012: Use of NASG as life-saving tool in hypovolemic shock to survive delays • GLOWM, 2012: • keep woman in shock stable during transport

13. UNFPA • Kate Gilmore modelled the NASG during a press conference at Women Deliver on Thursday • Hope to get into kits if appropriate

14. WHO and UCSF • Working on training materials for humanitarian settings

15. THANK YOU