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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

990

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Apr 2006

Typical duration for phase_1

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

March 17, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed

11 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

July 15, 2011

Completed

Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

2.2 years

First QC Date

March 17, 2006

Results QC Date

July 7, 2009

Last Update Submit

May 9, 2013

Conditions

Hypovolemic Shock Hemorrhage

Keywords

maternal mortalityobstetric hemorrhage

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Blood Loss Due to Obstetric Hemorrhage
within 72 hours of study enrollment
Emergency Hysterectomy
within 72 hours of study enrollment

Study Arms (2)

Pre-Intervention

NO INTERVENTION

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

Post-Intervention

EXPERIMENTAL

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

Device: Non-pneumatic Anti-shock Garment (NASG)

Interventions

Non-pneumatic Anti-shock Garment (NASG)DEVICE

In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.

Also known as: NASG, Manufactured by Zoex, Anti-Shock Garment, Life Wrap

Post-Intervention

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

blood loss from obstetric hemorrhage \>= 1000 mL
pulse \> 100 beats per minute or systolic blood pressure \< 100 mmHg

You may not qualify if:

current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins
current bleeding sites above the diaphragm.
history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of California, San Franciscolead
MacArthur Foundationcollaborator

Study Sites (2)

Assuit University Hospital

Asyut, Egypt

Location

El-Galaa Teaching Hospital

Cairo, Egypt

Location

Related Publications (6)

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.
PMID: 16553654RESULT
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.
PMID: 18805742RESULT
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.
PMID: 21190486RESULT
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.
PMID: 20955600RESULT
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.
PMID: 20809942RESULT
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.
PMID: 19280394RESULT

MeSH Terms

Conditions

ShockHemorrhageMaternal Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsParental DeathDeath

Limitations and Caveats

Non-randomized, non-blinded pre-intervention/intervention design

Results Point of Contact

Title: Suellen Miller
Organization: University of California San Francisco (UCSF)

Study Officials

Suellen Miller, CNM, PhD, RN
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 21, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 14, 2013

Results First Posted

July 15, 2011

Record last verified: 2013-05

Locations

EG(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Pre-Intervention

Post-Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (6)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Pre-Intervention

Post-Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (6)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations