A Phase 1/2 interventional study of Non-pneumatic Anti-shock Garment (NASG) in Hypovolemic Shock and Hemorrhage, sponsored by University of California, San Francisco. Completed at 2 sites in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-14.
Sponsored by University of California, San Francisco · Phase 1/2, Interventional, and Treatment
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 990 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Absolute exclusion criteria:
Relative exclusion criteria:
The Pre-Intervention Phase served as the Control / Baseline group.
Intervention used in this phase and outcomes compared to the Pre-Intervention phase.
Device: 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.
Also known as: NASG, Manufactured by Zoex, Anti-Shock Garment, Life Wrap
Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)
Time frame: from early pregnancy to within 3 weeks postpartum
Blood Loss Due to Obstetric Hemorrhage
cumulative blood loss measured hourly upon study admission by calibrated blood collection drape
Time frame: within 72 hours of study enrollment
Emergency Hysterectomy
incidence of emergency hysterectomy for cases of uterine atony
Time frame: within 72 hours of study enrollment
| Milestone | Pre-Intervention | Post-Intervention |
|---|---|---|
| Started | 432 | 559 |
| Completed | 432 | 558 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| participants | Pre-Intervention | Post-Intervention |
|---|---|---|
| Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) | 27 | 11 |
cumulative blood loss measured hourly upon study admission by calibrated blood collection drape
| mL | Pre-Intervention | Post-Intervention |
|---|---|---|
| Blood Loss Due to Obstetric Hemorrhage | 378.9 ± 234.3 | 253.2 ± 205.3 |
incidence of emergency hysterectomy for cases of uterine atony
| participants | Pre-Intervention | Post-Intervention |
|---|---|---|
| Emergency Hysterectomy | 35 | 28 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-Intervention | — | 10/432 (2.3%) | 17/432 (3.9%) |
| Post-Intervention | — | 6/558 (1.1%) | 5/558 (0.9%) |
| Event | Pre-Intervention | Post-Intervention |
|---|---|---|
| MortalityPregnancy, puerperium and perinatal conditions | 10/432 | 6/558 |
| Event | Pre-Intervention | Post-Intervention |
|---|---|---|
| Renal FailureRenal and urinary disorders | 14/432 | 3/558 |
| Acute Respitory Distress Syndrome (ARDS)Respiratory, thoracic and mediastinal disorders | 3/432 | 0/558 |
| Cerebral ImpairmentNervous system disorders | 2/432 | 2/558 |
| Cardiac FailureCardiac disorders | 1/432 | 0/558 |
| Age Continuous(years) | Pre-Intervention | Post-Intervention | Total |
|---|---|---|---|
| Mean | 28.7 ± 6.2 | 28.9 ± 6.0 | 28.8 ± 6.2 |
| Sex: Female, Male(Participants) | Pre-Intervention | Post-Intervention | Total |
|---|---|---|---|
| Female | 432 | 558 | 990 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pre-Intervention | Post-Intervention | Total |
|---|---|---|---|
| Egypt | 432 | 558 | 990 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco