Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: July 7, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypovolemic Shock
Hemorrhage
Intervention: Device: Non-pneumatic Anti-shock Garment (NASG)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pre-Intervention Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.
Post-Intervention Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.

Participant Flow:   Overall Study
    Pre-Intervention     Post-Intervention  
STARTED     432     559  
COMPLETED     432     558  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pre-Intervention facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
Post-Intervention facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Total Total of all reporting groups

Baseline Measures
    Pre-Intervention     Post-Intervention     Total  
Number of Participants  
[units: participants]
  432     558     990  
Age  
[units: years]
Mean ± Standard Deviation
  28.7  ± 6.2     28.9  ± 6.0     28.8  ± 6.2  
Gender  
[units: participants]
     
Female     432     558     990  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Egypt     432     558     990  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Blood Loss Due to Obstetric Hemorrhage   [ Time Frame: within 72 hours of study enrollment ]

3.  Secondary:   Emergency Hysterectomy   [ Time Frame: within 72 hours of study enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Non-randomized, non-blinded pre-intervention/intervention design


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Suellen Miller
Organization: University of California San Francisco (UCSF)
phone: 415 597 9394
e-mail: smiller@globalhealth.ucsf.edu , suellenmiller@gmail.com


Publications of Results:


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