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

Phase 1

Completed

• Conditions: Hemorrhage; Hypovolemic Shock
• Interventions: Device: Non-pneumatic Anti-shock Garment (NASG)

• Registration Number: NCT00305253
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study First Submitted: 2006-03-17
• Study First Submitted QC: 2006-03-17
• Study First Posted: 2006-03-21
• Study Start: 2006-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-07-07
• Results First Submitted QC: 2011-06-18
• Results First Posted: 2011-07-15
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 990

Inclusion Criteria

• blood loss from obstetric hemorrhage >= 1000 mL
• pulse > 100 beats per minute or systolic blood pressure < 100 mmHg

Exclusion Criteria

Absolute exclusion criteria:

• current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins
• current bleeding sites above the diaphragm.

Relative exclusion criteria:

• history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Intervention	Non-pneumatic Anti-shock Garment (NASG)	Intervention used in this phase and outcomes compared to the Pre-Intervention phase.

Primary Outcome Measures

Name	Time	Method
Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)	from early pregnancy to within 3 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
Emergency Hysterectomy	within 72 hours of study enrollment	incidence of emergency hysterectomy for cases of uterine atony
Blood Loss Due to Obstetric Hemorrhage	within 72 hours of study enrollment	cumulative blood loss measured hourly upon study admission by calibrated blood collection drape

Trial Locations

Locations (2)

El-Galaa Teaching Hospital; 🇪🇬 Cairo, Egypt

Assuit University Hospital; 🇪🇬 Assiut, Egypt