Non-Pneumatic Anti-Shock Garment (NASG), a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage: A Cluster Randomized Trial

Abstract

BackgroundObstetric 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 FindingsWe 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.ConclusionsDespite 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 RegistrationClinicalTrials.gov NCT00488462

The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next?

“…There were no statistically significant improvements in outcomes, but the reduction in 'extreme adverse outcome' was 54% (odds ratio, OR 0.46; 95% CI 0.13-1.62), and the reduction in mortality was 46% (OR 0.54; 95% CI 0.14-2.05). 50 The WHO recommends its use as a temporising measure until appropriate care is available. 14 …”

Experience in the use of non-pneumatic anti-shock garment (NASG) in the management of postpartum haemorrhage with hypovolemic shock in the Fundación Valle Del Lili, Cali, Colombia

“…A systematic review of five of these studies ( n  = 2330) showed a significant reduction in mortality, loss of blood, and a more rapid recovery of shock index (SI) in women when NASG was used [16]. A randomized clinical trial assessing the rapid implementation of NASG demonstrated a statistically significant reduction in SI recovery.…”

Maternal Health Innovations and Urbanization

“…First used for PPH in 2002, the device may assist women to survive delays in transport to facilities for treatment. The circumferential compression provided by the NASG is thought to reduce vascular volume under the compressed areas, expand the circulating blood volume, and reduce blood loss [ 29 ].…”