Cost-effectiveness of the non-pneumatic anti-shock garment (NASG): evidence from a cluster randomized controlled trial in Zambia and Zimbabwe.

BACKGROUND: Obstetric hemorrhage is the leading cause of maternal mortality, particularly in low resource settings where delays in obtaining definitive care contribute to high rates of death. The non-pneumatic anti-shock garment (NASG) first-aid device has been demonstrated to be highly cost-effective when applied at the referral hospital (RH) level. In this analysis we evaluate the incremental cost-effectiveness of early NASG application at the Primary Health Center (PHC) compared to later application at the RH in Zambia and Zimbabwe. METHODS: We obtained data on health outcomes and costs from a cluster-randomized clinical trial (CRCT) and participating study hospitals. We translated health outcomes into disability-adjusted life years (DALYs) using standard methods. Econometric regressions estimated the contribution of earlier PHC NASG application to DALYs and costs, varying geographic covariates (country, referral hospital) to yield regression models best fit to the data. We calculated cost-effectiveness as the ratio of added costs to averted DALYs for earlier PHC NASG application compared to later RH NASG application. RESULTS: Overall, the cost-effectiveness of early application of the NASG at the primary health care level compared to waiting until arrival at the referral hospital was $21.78 per DALY averted ($15.51 in added costs divided by 0.712 DALYs averted per woman, both statistically significant). By country, the results were very similar in Zambia, though not statistically significant in Zimbabwe. Sensitivity analysis suggests that results are robust to a per-protocol outcome analysis and are sensitive to the cost of blood transfusions. CONCLUSIONS: Early NASG application at the PHC for women in hypovolemic shock has the potential to be cost-effective across many clinical settings. The NASG is designed to reverse shock and decrease further bleeding for women with obstetric hemorrhage; therefore, women who have received the NASG earlier may be better able to survive delays in reaching definitive care at the RH and recover more quickly from shock, all at a cost that is highly acceptable.

Access to transport for women with hypovolemic shock differs according to weeks of pregnancy.

OBJECTIVE: To examine whether women with hypovolemic shock secondary to obstetric hemorrhage are transported to referral hospitals differently depending on weeks of pregnancy in Zambia. METHODS: In a retrospective study, transport type, wait time, and transit time were assessed for women with obstetric hemorrhage and hypovolemic shock transported from 26 primary health centers to three referral hospitals during 2007-2012. A mean arterial pressure of less than 60 mm Hg was used to indicate severe shock. Women were split into two categories on the basis of the number of weeks of pregnancy (<24 weeks vs ≥24 weeks). RESULTS: Overall, 616 women were included. Mode of transport differed significantly by group (P<0.001). 414 (93.0%) of 445 women at 24 weeks of pregnancy or more were transported by ambulance versus 114 (66.7%) of 171 women at less than 24 weeks. Among those in severe shock, 106 (93.0%) of 114 women at 24 weeks of pregnancy or more were transported in ambulances versus 26 (52.0%) of 50 women at less than 24 weeks (P<0.001). CONCLUSION: Women at 24 weeks of pregnancy or more were given preference for ambulance transport even when signs of shock were equivalent. Policy-makers aiming to lower maternal mortality need to address transport issues regardless of the etiology of hemorrhage or week of pregnancy.

Non-pneumatic anti-shock garment (NASG), a first-aid device to decrease maternal mortality from obstetric hemorrhage: a cluster randomized trial.

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.