Hemorrhage, Hypovolemic Shock
Conditions
Keywords
maternal mortality, obstetric hemorrhage
Brief 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.
Detailed 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.
Interventions
DEVICENon-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.
Sponsors
MacArthur Foundation
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* blood loss from obstetric hemorrhage \>= 1000 mL * pulse \> 100 beats per minute or systolic blood pressure \< 100 mmHg
Exclusion criteria
Absolute
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss Due to Obstetric Hemorrhage | within 72 hours of study enrollment | cumulative blood loss measured hourly upon study admission by calibrated blood collection drape |
| Emergency Hysterectomy | within 72 hours of study enrollment | incidence of emergency hysterectomy for cases of uterine atony |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-Intervention facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria. | 432 |
| Post-Intervention facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria. | 558 |
| Total | 990 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Pre-Intervention | Post-Intervention | Total |
|---|---|---|---|
| Age Continuous | 28.7 years STANDARD_DEVIATION 6.2 | 28.9 years STANDARD_DEVIATION 6 | 28.8 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment Egypt | 432 participants | 558 participants | 990 participants |
| Sex: Female, Male Female | 432 Participants | 558 Participants | 990 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 432 | 5 / 558 |
| serious Total, serious adverse events | 10 / 432 | 6 / 558 |
Outcome results
Primary
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
Population: All patients enrolled in the study were used in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Intervention | Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) | 27 participants |
| Post-Intervention | Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) | 11 participants |
Comparison: Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used.p-value: 0.01995% CI: [0.17, 0.85]Regression, Logistic
Secondary
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
Population: Blood loss information was missing on some patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Intervention | Blood Loss Due to Obstetric Hemorrhage | 378.9 mL | Standard Deviation 234.3 |
| Post-Intervention | Blood Loss Due to Obstetric Hemorrhage | 253.2 mL | Standard Deviation 205.3 |
Comparison: Mean measured volume of blood loss in the drape was compared across phases with t-tests.p-value: <0.0001t-test, 2 sided
Secondary
Emergency Hysterectomy
incidence of emergency hysterectomy for cases of uterine atony
Time frame: within 72 hours of study enrollment
Population: Data on emergency hysterectomy are only for women with diagnosis of uterine atony.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Intervention | Emergency Hysterectomy | 35 participants |
| Post-Intervention | Emergency Hysterectomy | 28 participants |
Comparison: Relative risks and confidence intervals were computed for emergency hysterectomy.p-value: <0.0595% CI: [0.21, 0.8]t-test, 2 sided