Phase 2
N=991
Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
Hypovolemic Shock · Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00305253 ↗Enrolled (actual)
991
Serious AEs
1.6%
Results posted
Jul 2011
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Non-pneumatic Anti-shock Garment (NASG) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2008
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 |
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.
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.