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

This study has been completed.
Sponsor:
Collaborator:
MacArthur Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305253
First received: March 17, 2006
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hypovolemic Shock
Hemorrhage
Device: Non-pneumatic Anti-shock Garment (NASG)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Loss Due to Obstetric Hemorrhage [ Time Frame: within 72 hours of study enrollment ] [ Designated as safety issue: No ]
    cumulative blood loss measured hourly upon study admission by calibrated blood collection drape

  • Emergency Hysterectomy [ Time Frame: within 72 hours of study enrollment ] [ Designated as safety issue: No ]
    incidence of emergency hysterectomy for cases of uterine atony


Enrollment: 990
Study Start Date: April 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pre-Intervention
The Pre-Intervention Phase served as the Control / Baseline group.
Experimental: Post-Intervention
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.
Other Names:
  • NASG
  • Manufactured by Zoex
  • Anti-Shock Garment
  • Life Wrap

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305253

Locations
Egypt
Assuit University Hospital
Assiut, Egypt
El-Galaa Teaching Hospital
Cairo, Egypt
Sponsors and Collaborators
University of California, San Francisco
MacArthur Foundation
Investigators
Principal Investigator: Suellen Miller, CNM, PhD, RN University of California, San Francisco
  More Information

Additional Information:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00305253     History of Changes
Other Study ID Numbers: 05-84956-000-GSS
Study First Received: March 17, 2006
Results First Received: July 7, 2009
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
maternal mortality
obstetric hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Shock
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014