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

May 9, 2013 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

990

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assuit University Hospital
      • Cairo, Egypt
        • El-Galaa Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • Anti-Shock Garment
  • Manufactured by Zoex
  • Life Wrap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from early pregnancy to within 3 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 72 hours of study enrollment
Emergency Hysterectomy
Time Frame: within 72 hours of study enrollment
incidence of emergency hysterectomy for cases of uterine atony
within 72 hours of study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

MacArthur Foundation

Investigators

  • Principal Investigator: Suellen Miller, CNM, PhD, RN, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 17, 2006

First Submitted That Met QC Criteria

March 17, 2006

First Posted (Estimate)

March 21, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-84956-000-GSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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