Hemorrhage Clinical Trial
Official title:
Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
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.
Status | Completed |
Enrollment | 990 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Assuit University Hospital | Assiut | |
Egypt | El-Galaa Teaching Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | MacArthur Foundation |
Egypt,
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 — View Citation
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 A — View Citation
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. Review. — View Citation
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 ha — View Citation
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? Evide — View Citation
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 hemorrh — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
Secondary | Emergency Hysterectomy | incidence of emergency hysterectomy for cases of uterine atony | within 72 hours of study enrollment | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02815670 -
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
|
Phase 3 | |
Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
Recruiting |
NCT02972385 -
Pharmacogenomics of Warfarin in Hispanics and Latinos
|
||
Completed |
NCT02569606 -
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
|
||
Completed |
NCT02554006 -
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
|
N/A | |
Recruiting |
NCT02446730 -
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
|
Phase 4 | |
Completed |
NCT01955720 -
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
|
Phase 1 | |
Completed |
NCT01935427 -
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
|
N/A | |
Recruiting |
NCT01709786 -
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Completed |
NCT01191554 -
Dose-ranging Study of Tranexamic Acid in Valve Surgery
|
N/A | |
Completed |
NCT01085006 -
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
|
Phase 1/Phase 2 | |
Completed |
NCT00700141 -
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
|
N/A | |
Completed |
NCT00375466 -
Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
|
N/A | |
Completed |
NCT00147420 -
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
|
N/A | |
Completed |
NCT00479362 -
Anticoagulant Therapy During Pacemaker Implantation
|
Phase 4 | |
Recruiting |
NCT05945680 -
Tranexamic Acid in Breast Esthetic Surgery.
|
Phase 4 | |
Completed |
NCT03273322 -
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05672407 -
The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
|
Phase 4 |