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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305253
• Other study ID #: 05-84956-000-GSS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 17, 2006
• Last updated: May 9, 2013
• Start date: April 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Hypovolemic Shock
• Shock

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assuit University Hospital	Assiut
Egypt	El-Galaa Teaching Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	MacArthur Foundation

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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 — View Citation

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 A — View Citation

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. Review. — View Citation

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 ha — View Citation

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? Evide — View Citation

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 hemorrh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)		from early pregnancy to within 3 weeks postpartum	No
Secondary	Blood Loss Due to Obstetric Hemorrhage	cumulative blood loss measured hourly upon study admission by calibrated blood collection drape	within 72 hours of study enrollment	No
Secondary	Emergency Hysterectomy	incidence of emergency hysterectomy for cases of uterine atony	within 72 hours of study enrollment	No

External Links

•   Information and updates on current trials using the Life Wrap (NASG) for obstetric hemorrhage in low resource settings.
•   Safe Motherhood Program details at University of California, San Francisco