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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Non-Pneumatic Anti-Shock Garment (NASG), a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage: A Cluster Randomized Trial
PLoS ONE, Volume 8, No. 10, Article e76477, Year 2013
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Description
Background:Obstetric hemorrhage is the leading cause of maternal mortality. Using a cluster randomized design, we investigated whether application of the Non-pneumatic Anti-Shock Garment (NASG) before transport to referral hospitals (RHs) from primary health care centers (PHCs) decreased adverse outcomes among women with hypovolemic shock. We hypothesized the NASG group would have a 50% reduction in adverse outcomes.Methods and Findings:We randomly assigned 38 PHCs in Zambia and Zimbabwe to standard obstetric hemorrhage/shock protocols or the same protocols plus NASG prior to transport. All women received the NASG at the RH. The primary outcomes were maternal mortality; severe, end-organ failure maternal morbidity; and a composite mortality/morbidity outcome, which we labeled extreme adverse outcome (EAO). We also examined whether the NASG contributed to negative side effects and secondary outcomes. The sample size for statistical power was not reached; of a planned 2400 women, 880 were enrolled, 405 in the intervention group. The intervention was associated with a non-significant 46% reduced odds of mortality (OR 0.54, 95% CI 0.14-2.05, p = 0.37) and 54% reduction in composite EAO (OR 0.46, 95% CI 0.13-1.62, p = 0.22). Women with NASGs recovered from shock significantly faster (HR 1.25, 95% CI 1.02-1.52, p = 0.03). No differences were observed in secondary outcomes or negative effects. The main limitation was small sample size.Conclusions:Despite a lack of statistical significance, the 54% reduced odds of EAO and the significantly faster shock recovery suggest there might be treatment benefits from earlier application of the NASG for women experiencing delays obtaining definitive treatment for hypovolemic shock. As there are no other tools for shock management outside of referral facilities, and no safety issues found, consideration of NASGs as a temporizing measure during delays may be warranted. A pragmatic study with rigorous evaluation is suggested for further research.Trial Registration:ClinicalTrials.gov NCT00488462. © 2013 Miller et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3806786/bin/pone.0076477.s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3806786/bin/pone.0076477.s002.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3806786/bin/pone.0076477.s003.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3806786/bin/pone.0076477.s004.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3806786/bin/pone.0076477.s005.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3806786/bin/pone.0076477.s006.pdf
Authors & Co-Authors
Miller, Suellen P.
United States, San Francisco
University of California, San Francisco
Bergel, Eduardo F.
Argentina, Buenos Aires
Instituto de Efectividad Clínica y Sanitaria
El Ayadi, Alison Marie
United States, San Francisco
University of California, San Francisco
Gibbons, Luz
Argentina, Buenos Aires
Instituto de Efectividad Clínica y Sanitaria
Butrick, Elizabeth A.
United States, San Francisco
University of California, San Francisco
Magwali, Thulani Lesley
Zimbabwe, Harare
University of Zimbabwe
Mkumba, Gricelia
Zambia, Lusaka
University Teaching Hospital Lusaka
Kaseba, Christine M.
Zambia, Lusaka
University Teaching Hospital Lusaka
Nguyen, My Huong
Switzerland, Geneva
Organisation Mondiale de la Santé
Geissler, Jillian D.
United States, San Francisco
University of California, San Francisco
Merialdi, Mario
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 11
Authors: 11
Affiliations: 5
Identifiers
Doi:
10.1371/journal.pone.0076477
e-ISSN:
19326203
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Zambia
Zimbabwe
Participants Gender
Female