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POPPHI 2009 UPDATE NON-PNEUMATIC ANTI- SHOCK GARMENT (NASG) POPPHI 2009 UPDATE SUELLEN MILLER, CNM, PHD DIRECTOR, SAFE MOTHERHOOD PROGRAMS, BIXBY CENTER FOR GLOBAL REPRODUCTIVE HEALTH, UCSF Presented by Carinne Meyer, MA, MPH
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The NASG: Low-cost, Low Tech Life Saving Device
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Update on Research Nigeria: Pre-Post Study (Completed) Egypt: Pre-Post Study (Completed) Zambia/Zimbabwe: Cluster Randomized Trial (In Progress)
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Nigeria Study (Mar. 04 – Nov. 08) Pre-intervention/intervention study design 12 referral hospitals in Northern and Southern Nigeria Entry criteria were OH of any etiology (> = 750 ml) and one clinical sign of shock. Outcomes: mean measured blood loss and mortality. PhaseN=756 Pre-intervention /Standard Treatment 182 Intervention / NASG574
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Ongoing Collaboration
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Egypt Study (June 06 – May 08) Pre-intervention/intervention study design 2 referral facilities in Egypt Entry criteria were OH of any etiology (> = 750 ml) and one clinical sign of shock. Outcomes: mean measured blood loss, mortality, severe morbidities and extreme adverse outcomes. PhaseN=990 Pre-intervention /Standard Treatment 432 Intervention / NASG558
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Zambia/Zimbabwe RCT Design: Cluster Randomized Trial Funding: NIH and Gates Foundation Data Coordination: WHO, RHRU Data Management: Centro Rosario Estudios Perinatales (CREP) (Argentina) OpenClinica Research Collaboration: University Teaching Hospital in Lusaka, Zambia and the University of Zimbabwe (UZ-UCSF RH Collaborative)
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Why a RCT? The RCT is designed to early application determine if early application at the primary care level by midwives will IMPROVE MATERNAL OUTCOMES.
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Randomized Cluster Trial Clinics Referral Hospital SiteClusters Harare12 Lusaka12 Copperbelt13
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Study Design – Example Lusaka
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Study Timeline October 2007October 2008 June 2008 October 2009May 2009 Feb 2009 July 2009 LUSAKA – Phase 1 HARARE – Phase 1 LUSAKA – Phase 3 LUSAKA – Phase 2 HARARE – Phase 3 HARARE – Phase 2 COPPERBELT– Phase 3 COPPERBELT– Phase 2 COPPERBELT– Phase 1
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Thank You.
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