Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
|ClinicalTrials.gov Identifier: NCT00305253|
Recruitment Status : Completed
First Posted : March 21, 2006
Results First Posted : July 15, 2011
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypovolemic Shock Hemorrhage||Device: Non-pneumatic Anti-shock Garment (NASG)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||990 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt|
|Study Start Date :||April 2006|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
No Intervention: Pre-Intervention
The Pre-Intervention Phase served as the Control / Baseline group.
Intervention used in this phase and outcomes compared to the Pre-Intervention phase.
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.
- Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) [ Time Frame: from early pregnancy to within 3 weeks postpartum ]
- Blood Loss Due to Obstetric Hemorrhage [ Time Frame: within 72 hours of study enrollment ]cumulative blood loss measured hourly upon study admission by calibrated blood collection drape
- Emergency Hysterectomy [ Time Frame: within 72 hours of study enrollment ]incidence of emergency hysterectomy for cases of uterine atony
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305253
|Assuit University Hospital|
|El-Galaa Teaching Hospital|
|Principal Investigator:||Suellen Miller, CNM, PhD, RN||University of California, San Francisco|