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

Sponsors and Collaborators:	University of California, San Francisco MacArthur Foundation
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00305253

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt

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

Primary Outcome Measures:

Maternal mortality or severe morbidity [ Time Frame: from early pregnancy to within 3 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

a) blood loss due to obstetric hemorrhage, b) emergency hysterectomy, c) time to recovery from shock, d)negative effects related to NASG use [ Time Frame: within 72 hours of study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Post Intervention facilities will use the NASG when a patient meets the study criteria.	Device: non-pneumatic anti-shock garment (NASG) In the post phase of the study, the NASG will be used when a patient meets the study criteria.

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.

There are two Main Aims:

Aim 1: 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 outcomes are mortality and severe morbidity. Secondary outcomes include: a) decreased blood loss due to obstetric hemorrhage, b) fewer emergency hysterectomies, and c) more rapid recovery from shock in the intervention group as compared to the control group.

Aim 2: Using the same study design, to examine side effects that might be associated with NASG use, including a) decreased urine output, b) hypoxia, dyspnea, or other form of respiratory distress, c) nausea and vomiting in the intervention group as compared to the control group.

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

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

Contacts

Contact: Suellen Miller, CNM, PhD, RN	(415) 597-9394	suellenmiller@gmail.com
Contact: Janet M. Turan, PhD, MPH	(415) 597-9217	Janet.Turan@ucsf.edu

Locations

Egypt
El-Galaa Teaching Hospital	Recruiting
Cairo, Egypt
Contact: Mohammed Mourad, MD 0122242224 dr_mohamed_mourad@yahoo.com
Principal Investigator: Mohammed Mourad, MD
Assuit University Hospital	Recruiting
Assiut, Egypt
Contact: Mohammed Fathalla, MD 0020-88-316205 mofath@hotmail.com
Principal Investigator: Mohammed Fathalla, MD

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

Responsible Party:	University of California, San Francisco ( Suellen Miller )
Study ID Numbers:	05-84956-000-GSS
Study First Received:	March 17, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00305253
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

maternal mortality
obstetric hemorrhage

Study placed in the following topic categories:

Shock
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009