Phase 2
Completed N=991
Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
Hypovolemic Shock · hemorrhage
Source: ClinicalTrials.gov NCT00305253 ↗
Enrolled (actual)
991
Serious AEs
1.6%
Results posted
Jul 2011
Primary outcomePrimary: Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) — 27; 11 participants — p=0.019
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) |
27; 11 | 0.019 sig |
| SECONDARY Blood Loss Due to Obstetric Hemorrhage |
378.9; 253.2 | <0.0001 sig |
| SECONDARY Emergency Hysterectomy |
35; 28 | <0.05 sig |
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)
Data sourced from ClinicalTrials.gov (NCT00305253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.