Per-protocol effect of earlier non-pneumatic anti-shock garment application for obstetric hemorrhage

摘要

Obstetric hemorrhage is the primary cause of maternal mortality worldwide, especially in lower-resource settings that are characterized by treatment delays [1]. The non-pneumatic anti-shock garment (NASG) is a first-aid device used to stabilize women in shock from obstetric hemorrhage until they can receive definitive care. The authors conducted a cluster-randomized trial (CRT) to evaluate NASG application at the primary health clinic prior to referral hospital transfer on maternal outcomes. Control participants received the NASG upon arrival at the referral hospital. The intent-to-treat analysis (ITT) reported a non-statistically significant 46% reduction in mortality, 54% reduction in extreme adverse outcomes, and a significant 25% faster recovery from shock associated with earlier NASG intervention [2]. However, protocol violations occurred, potentially diluting the intervention effect. Thus, the effect of earlier NASG application was evaluated using 2 per-protocol analysis strategies.