Early application of the non-pneumatic anti-shock garment (NASG), a first-aid device to decrease maternal mortality from obstetric hemorrhage: A cluster randomized trial

Obstetric hemorrhage is the leading cause of maternal mortality worldwide. Using a cluster randomized design, we investigated whether application of the Non-pneumatic Anti-Shock Garment (NASG), a low-technology first-aid device, applied before transport to referral hospitals (RHs) from primary health care centers (PHCs) decreased extreme adverse outcomes (EAO, mortality or severe morbidity) among women with hypovolemic shock in Zambia and Zimbabwe, compared to women who received the NASG on RH arrival. We compared treatment groups using intention-to-treat analyses. We estimated random effects logistic and linear regression models to account for cluster design and adjusted cox regression models for time-to-event data. The sample size for statistical power was not reached; of 2400 planned women, 880 were enrolled, 405 in the intervention group. The intervention was associated with a non-statistically significant 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 from NASG use. The main limitation was small sample size. Despite a lack of statistical significance, the 54% reduced odds of EAO and significantly faster shock recovery suggest 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.