Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MacArthur Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Intervention | No Intervention | The Pre-Intervention Phase served as the Control / Baseline group. | |
| Post-Intervention | Experimental | Intervention used in this phase and outcomes compared to the Pre-Intervention phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-pneumatic Anti-shock Garment (NASG) | Device | In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss Due to Obstetric Hemorrhage | cumulative blood loss measured hourly upon study admission by calibrated blood collection drape | within 72 hours of study enrollment |
| Emergency Hysterectomy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Absolute exclusion criteria:
Relative exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suellen Miller, CNM, PhD, RN | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuit University Hospital | Asyut | Egypt | ||||
| El-Galaa Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16553654 | Result | Miller S, Hamza S, Bray EH, Lester F, Nada K, Gibson R, Fathalla M, Mourad M, Fathy A, Turan JM, Dau KQ, Nasshar I, Elshair I, Hensleigh P. First aid for obstetric haemorrhage: the pilot study of the non-pneumatic anti-shock garment in Egypt. BJOG. 2006 Apr;113(4):424-9. doi: 10.1111/j.1471-0528.2006.00873.x. | |
| 18805742 | Result |
| Label | URL |
|---|---|
| Information and updates on current trials using the Life Wrap (NASG) for obstetric hemorrhage in low resource settings. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Intervention | Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol. |
| FG001 | Post-Intervention | Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Intervention | facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria. |
| BG001 | Post-Intervention | facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) | All patients enrolled in the study were used in this analysis. | Posted | Number | participants | from early pregnancy to within 3 weeks postpartum |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Intervention | facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Failure | Renal and urinary disorders | Systematic Assessment | Other adverse events are all designated as morbidities in publications. Three individuals in the pre-intervention group suffered two other adverse events each, but in analysis are considered single morbidities. |
Non-randomized, non-blinded pre-intervention/intervention design
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suellen Miller | University of California San Francisco (UCSF) | 415 597 9394 | smiller@globalhealth.ucsf.edu , suellenmiller@gmail.com |
Not provided
| ID | Term |
|---|---|
| D012769 | Shock |
| D006470 | Hemorrhage |
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D063129 | Parental Death |
| D003643 | Death |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
incidence of emergency hysterectomy for cases of uterine atony
| within 72 hours of study enrollment |
| Cairo |
| Egypt |
| Miller S, Martin HB, Morris JL. Anti-shock garment in postpartum haemorrhage. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):1057-74. doi: 10.1016/j.bpobgyn.2008.08.008. Epub 2008 Sep 20. |
| 21190486 | Result | Turan J, Ojengbede O, Fathalla M, Mourad-Youssif M, Morhason-Bello IO, Nsima D, Morris J, Butrick E, Martin H, Camlin C, Miller S. Positive effects of the non-pneumatic anti-shock garment on delays in accessing care for postpartum and postabortion hemorrhage in Egypt and Nigeria. J Womens Health (Larchmt). 2011 Jan;20(1):91-8. doi: 10.1089/jwh.2010.2081. Epub 2010 Dec 29. |
| 20955600 | Result | Miller S, Fathalla MM, Ojengbede OA, Camlin C, Mourad-Youssif M, Morhason-Bello IO, Galadanci H, Nsima D, Butrick E, Al Hussaini T, Turan J, Meyer C, Martin H, Mohammed AI. Obstetric hemorrhage and shock management: using the low technology Non-pneumatic Anti-Shock Garment in Nigerian and Egyptian tertiary care facilities. BMC Pregnancy Childbirth. 2010 Oct 18;10:64. doi: 10.1186/1471-2393-10-64. |
| 20809942 | Result | Mourad-Youssif M, Ojengbede OA, Meyer CD, Fathalla M, Morhason-Bello IO, Galadanci H, Camlin C, Nsima D, Al Hussaini T, Butrick E, Miller S. Can the Non-pneumatic Anti-Shock Garment (NASG) reduce adverse maternal outcomes from postpartum hemorrhage? Evidence from Egypt and Nigeria. Reprod Health. 2010 Sep 1;7:24. doi: 10.1186/1742-4755-7-24. |
| 19280394 | Result | Miller S, Turan JM, Dau K, Fathalla M, Mourad M, Sutherland T, Hamza S, Lester F, Gibson EB, Gipson R, Nada K, Hensleigh P. Use of the non-pneumatic anti-shock garment (NASG) to reduce blood loss and time to recovery from shock for women with obstetric haemorrhage in Egypt. Glob Public Health. 2007;2(2):110-24. doi: 10.1080/17441690601012536. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Blood Loss Due to Obstetric Hemorrhage | cumulative blood loss measured hourly upon study admission by calibrated blood collection drape | Blood loss information was missing on some patients. | Posted | Mean | Standard Deviation | mL | within 72 hours of study enrollment |
|
|
|
|
| Secondary | Emergency Hysterectomy | incidence of emergency hysterectomy for cases of uterine atony | Data on emergency hysterectomy are only for women with diagnosis of uterine atony. | Posted | Number | participants | within 72 hours of study enrollment |
|
|
|
|
| 10 |
| 432 |
| 17 |
| 432 |
| EG001 | Post-Intervention | facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria. | 6 | 558 | 5 | 558 |
|
| Acute Respitory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cerebral Impairment | Nervous system disorders | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | Systematic Assessment |
|
Local PIs are required to review results with Dr. Miller before releasing.