Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
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About
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.
Full 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.
Enrollment
Sex
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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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
990 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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