Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
NCT ID: NCT00305253
Last Updated: 2013-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
990 participants
INTERVENTIONAL
2006-04-30
2008-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pre-Intervention
The Pre-Intervention Phase served as the Control / Baseline group.
No interventions assigned to this group
Post-Intervention
Intervention used in this phase and outcomes compared to the Pre-Intervention phase.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pulse \> 100 beats per minute or systolic blood pressure \< 100 mmHg
Exclusion Criteria
* current bleeding sites above the diaphragm.
* history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)
18 Years
FEMALE
No
Sponsors
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MacArthur Foundation
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Suellen Miller, CNM, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Assuit University Hospital
Asyut, , Egypt
El-Galaa Teaching Hospital
Cairo, , Egypt
Countries
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References
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Miller S, Hamza S, Bray EH, Lester F, Nada K, Gibson R, Fathalla M, Mourad M, Fathy A, Turan JM, Dau KQ, Nasshar I, Elshair I, Hensleigh P. First aid for obstetric haemorrhage: the pilot study of the non-pneumatic anti-shock garment in Egypt. BJOG. 2006 Apr;113(4):424-9. doi: 10.1111/j.1471-0528.2006.00873.x.
Miller S, Martin HB, Morris JL. Anti-shock garment in postpartum haemorrhage. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):1057-74. doi: 10.1016/j.bpobgyn.2008.08.008. Epub 2008 Sep 20.
Turan J, Ojengbede O, Fathalla M, Mourad-Youssif M, Morhason-Bello IO, Nsima D, Morris J, Butrick E, Martin H, Camlin C, Miller S. Positive effects of the non-pneumatic anti-shock garment on delays in accessing care for postpartum and postabortion hemorrhage in Egypt and Nigeria. J Womens Health (Larchmt). 2011 Jan;20(1):91-8. doi: 10.1089/jwh.2010.2081. Epub 2010 Dec 29.
Miller S, Fathalla MM, Ojengbede OA, Camlin C, Mourad-Youssif M, Morhason-Bello IO, Galadanci H, Nsima D, Butrick E, Al Hussaini T, Turan J, Meyer C, Martin H, Mohammed AI. Obstetric hemorrhage and shock management: using the low technology Non-pneumatic Anti-Shock Garment in Nigerian and Egyptian tertiary care facilities. BMC Pregnancy Childbirth. 2010 Oct 18;10:64. doi: 10.1186/1471-2393-10-64.
Mourad-Youssif M, Ojengbede OA, Meyer CD, Fathalla M, Morhason-Bello IO, Galadanci H, Camlin C, Nsima D, Al Hussaini T, Butrick E, Miller S. Can the Non-pneumatic Anti-Shock Garment (NASG) reduce adverse maternal outcomes from postpartum hemorrhage? Evidence from Egypt and Nigeria. Reprod Health. 2010 Sep 1;7:24. doi: 10.1186/1742-4755-7-24.
Miller S, Turan JM, Dau K, Fathalla M, Mourad M, Sutherland T, Hamza S, Lester F, Gibson EB, Gipson R, Nada K, Hensleigh P. Use of the non-pneumatic anti-shock garment (NASG) to reduce blood loss and time to recovery from shock for women with obstetric haemorrhage in Egypt. Glob Public Health. 2007;2(2):110-24. doi: 10.1080/17441690601012536.
Related Links
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Information and updates on current trials using the Life Wrap (NASG) for obstetric hemorrhage in low resource settings.
Other Identifiers
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05-84956-000-GSS
Identifier Type: -
Identifier Source: org_study_id
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