A comparative study of the Non-Pneumatic Anti-Shock Garment (NASG) on women with obstetric hemorrhage At-Risk for Eclampsia (ARE)

Objectives: To assess if using a first-aid device, the Non-pneumatic Anti-Shock Garment (NASG), is harmful or protective for women at risk for or experiencing eclampsia (ARE) who have hypovolemic shock secondary to obstetric hemorrhage. Methods: Two non-randomized pre-intervention / NASG intervention parent studies were conducted in Egypt and Nigeria between 2004 – 2008 with a total of 1,746 patients from 14 obstetric centers – 2 in Egypt and 12 in Nigeria. Inclusion criteria were that a woman experienced obstetric/pregnancy-related hemorrhage blood loss of at least 750ml and at least one clinical sign of hypovolemic shock (BP<100mmHg and/or pulse>100 beats per minute). A woman was considered ARE if she was clinically diagnosed with eclampsia or fulfilled one of four recognized criteria. Outcomes measured were severe morbidity or mortality, combined as Extreme Adverse Maternal Outcome (EAO). Results: Of 133 ARE women, 58 women were in the pre-intervention phase (unexposed) and 75 in the intervention phase (exposed/NASG). The NASG was found to have a significant protective effect for EAO: aOR 0.26, CI 0.07-0.93, with women treated with the NASG having 0.26 reduced odds of experiencing an EAO as compared to women in the pre-NASG phase. In sensitivity analyses, results were more pronounced among women diagnosed clinically with eclampsia (aOR 0.23, CI 0.06 – 0.97). Conclusions: Results suggest that the NASG is safe to use on all women, including women at risk for and diagnosed with eclampsia. Further data from a randomized controlled cluster trial underway in Zambia and Zimbabwe will provide more insight.