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

NCT ID: NCT00305253

Last Updated: 2013-05-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

990 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Hypovolemic Shock Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-Intervention

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Group Type EXPERIMENTAL

Non-pneumatic Anti-shock Garment (NASG)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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NASG Manufactured by Zoex Anti-Shock Garment Life Wrap

Eligibility Criteria

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Inclusion Criteria

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

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.


* history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MacArthur Foundation

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

El-Galaa Teaching Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

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.

Reference Type RESULT
PMID: 16553654 (View on PubMed)

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.

Reference Type RESULT
PMID: 18805742 (View on PubMed)

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.

Reference Type RESULT
PMID: 21190486 (View on PubMed)

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.

Reference Type RESULT
PMID: 20955600 (View on PubMed)

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.

Reference Type RESULT
PMID: 20809942 (View on PubMed)

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.

Reference Type RESULT
PMID: 19280394 (View on PubMed)

Related Links

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http://www.lifewrap.org

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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