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

Study Overview
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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.

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

Conditions
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Hypovolemic Shock, Hemorrhage

Intervention / Treatment
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* Device: Non-pneumatic Anti-shock Garment (NASG)


Participation Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Intervention<br>The Pre-Intervention Phase served as the Control / Baseline group. | |
| Experimental: Post-Intervention<br>Intervention used in this phase and outcomes compared to the Pre-Intervention phase. | Device: Non-pneumatic Anti-shock Garment (NASG)<br>* In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.<br>* Other names: Life Wrap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Emergency Hysterectomy | incidence of emergency hysterectomy for cases of uterine atony | within 72 hours of study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal mortality, obstetric hemorrhage