NCT00305253

Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 990 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG.

Detailed description

This is a comparative, pre-post study of the Non-pneumatic Anti-Shock Garment (NASG) to establish its effectiveness in reducing maternal mortality and morbidity due to obstetrical hemorrhage. The sites are two maternity teaching hospitals in Egypt: El Galaa, in Cairo and Assiut University in Assiut. Our main aim was to test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG. Our primary outcome was Extreme Adverse Outcomes (EAO) - a combined outcome of maternal mortality and severe morbidity. Secondary outcomes included mean measured blood loss and incidence of emergency hysterectomy.

Conditions

• Hypovolemic Shock
• Hemorrhage

Interventions

Type	Name	Description
DEVICE	Non-pneumatic Anti-shock Garment (NASG)	In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-03-21
• Last updated: 2013-05-14
• Results posted: 2011-07-15

Locations

2 sites across 1 country: Egypt