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

Primary Purpose

Hypovolemic Shock, Hemorrhage

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Non-pneumatic Anti-shock Garment (NASG)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovolemic Shock focused on measuring maternal mortality, obstetric hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Assuit University Hospital
  • El-Galaa Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-Intervention

Post-Intervention

Arm Description

The Pre-Intervention Phase served as the Control / Baseline group.

Intervention used in this phase and outcomes compared to the Pre-Intervention phase.

Outcomes

Primary Outcome Measures

Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)

Secondary Outcome Measures

Blood Loss Due to Obstetric Hemorrhage
cumulative blood loss measured hourly upon study admission by calibrated blood collection drape
Emergency Hysterectomy
incidence of emergency hysterectomy for cases of uterine atony

Full Information

First Posted
March 17, 2006
Last Updated
May 9, 2013
Sponsor
University of California, San Francisco
Collaborators
MacArthur Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00305253
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
MacArthur Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemic Shock, Hemorrhage
Keywords
maternal mortality, obstetric hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
990 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Intervention
Arm Type
No Intervention
Arm Description
The Pre-Intervention Phase served as the Control / Baseline group.
Arm Title
Post-Intervention
Arm Type
Experimental
Arm Description
Intervention used in this phase and outcomes compared to the Pre-Intervention phase.
Intervention Type
Device
Intervention Name(s)
Non-pneumatic Anti-shock Garment (NASG)
Other Intervention Name(s)
NASG, Manufactured by Zoex, Anti-Shock Garment, Life Wrap
Intervention Description
In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Blood Loss Due to Obstetric Hemorrhage
Description
cumulative blood loss measured hourly upon study admission by calibrated blood collection drape
Time Frame
within 72 hours of study enrollment
Title
Emergency Hysterectomy
Description
incidence of emergency hysterectomy for cases of uterine atony
Time Frame
within 72 hours of study enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Miller, CNM, PhD, RN
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit University Hospital
City
Assiut
Country
Egypt
Facility Name
El-Galaa Teaching Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16553654
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.
Results Reference
result
PubMed Identifier
18805742
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.
Results Reference
result
PubMed Identifier
21190486
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.
Results Reference
result
PubMed Identifier
20955600
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.
Results Reference
result
PubMed Identifier
20809942
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.
Results Reference
result
PubMed Identifier
19280394
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.
Results Reference
result

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

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