Clinical trial NCT00305253: Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
Official title: Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypovolemic Shock
Hemorrhage
Keywords: maternal mortality
obstetric hemorrhage
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: MacArthur Foundation
First posted: 2006-03-21
Enrollment: 990
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)
timeFrame: from early pregnancy to within 3 weeks postpartum
Secondary outcomes:
measure: Blood Loss Due to Obstetric Hemorrhage
timeFrame: within 72 hours of study enrollment
measure: Emergency Hysterectomy
timeFrame: within 72 hours of study enrollment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University Hospital
city: Cairo
country: Egypt
facility: El-Galaa Teaching Hospital
Study officials:
affiliation: University of California, San Francisco
name: Suellen Miller, CNM, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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 Apr;113(4):424-9. doi: 10.1111/j.1471-0528.2006.00873.x.
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.
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 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.
citation: 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.
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? Evidence from Egypt and Nigeria. Reprod Health. 2010 Sep 1;7:24. doi: 10.1186/1742-4755-7-24.
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 haemorrhage in Egypt. Glob Public Health. 2007;2(2):110-24. doi: 10.1080/17441690601012536.