Hemorrhage Clinical Trial
— NASGOfficial title:
Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe
This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.
Status | Completed |
Enrollment | 887 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
To participate in these study activities, women must be willing and able to participate,
be able to sign or mark a consent form, and speak one of the languages into which the
consent form has been translated, including English, Nyanja, and Bemba in Zambia, and
English, Shona and Ndebele in Zimbabwe. Inclusion Criteria: - Women who are pregnant or postpartum and experiencing obstetric hemorrhage with 2 of the following 3: blood loss > 500 mL (at SHF, 1000 mL at RH) SBP <100 mm Hg pulse >100 bpm Exclusion Criteria: - Absolute exclusion criteria include: current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins and/or current bleeding sites above the diaphragm. Relative exclusion criteria include: a history or current clinical evidence of mitral stenosis or congestive heart failure (CHF). These must be relative contraindications that will be assessed at the time of hemorrhage and clinical judgment will need to be utilized to evaluate each case individually. Thus if the patient can be transported and delivered rapidly and is suspected or known to have valvular heart disease, she will be excluded from the study. In other cases, depending on the severity of the hemorrhage, if the patient is dyspneic in the NASG, at the SHF level, the NASG will be loosened, if that does not result in relief, the NASG will be removed. If the patients at the RH have decreasing oxygen saturation levels as demonstrated by pulse oximeter, the NASG will be loosened, if that does not result in relief, the NASG will be removed. Women suffering obstetric hemorrhage and hypovolemic shock who have no detectable vital signs (non palpable pulse and BP) at the time of their arrival at the RH are ineligible for enrolment in the study ("non-resuscitable") if: 1) the woman does not respond to resuscitation attempts after 30 minutes and 2) more than three hours have elapsed between the start of hemorrhage and the beginning of her treatment. (As this is a clinical intervention of a potentially life saving device, the study clinicians should try the NASG on any patient if they feel it may resuscitate her; however, if the woman meets the criteria above they are ineligible for having their data entered into the study.) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Zambia | Kitwe Central Hospital | Kitwe | Copperbelt |
Zambia | University Teaching Hospital (UTH) | Lusaka | |
Zambia | Ndola Central Hospital | Ndola | Copperbelt |
Zimbabwe | Harare Hospital | Harare | |
Zimbabwe | Parienyatwa Group of Hospitals | Harare |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Zambia, University of Zimbabwe, World Health Organization |
Zambia, Zimbabwe,
Brees C, Hensleigh PA, Miller S, Pelligra R. A non-inflatable anti-shock garment for obstetric hemorrhage. Int J Gynaecol Obstet. 2004 Nov;87(2):119-24. — View Citation
Fathalla MM, Youssif MM, Meyer C, Camlin C, Turan J, Morris J, Butrick E, Miller S. Nonatonic obstetric haemorrhage: effectiveness of the nonpneumatic antishock garment in egypt. ISRN Obstet Gynecol. 2011;2011:179349. doi: 10.5402/2011/179349. Epub 2011 Aug 10. — View Citation
Kausar F, Morris JL, Fathalla M, Ojengbede O, Fabamwo A, Mourad-Youssif M, Morhason-Bello IO, Galadanci H, Nsima D, Butrick E, Miller S. Nurses in low resource settings save mothers' lives with non-pneumatic anti-shock garment. MCN Am J Matern Child Nurs. 2012 Sep;37(5):308-16. — View Citation
Lester F, Stenson A, Meyer C, Morris J, Vargas J, Miller S. Impact of the Non-pneumatic Antishock Garment on pelvic blood flow in healthy postpartum women. Am J Obstet Gynecol. 2011 May;204(5):409.e1-5. doi: 10.1016/j.ajog.2010.12.054. Epub 2011 Mar 24. — View Citation
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. — View Citation
Miller S, Fathalla MM, Youssif MM, Turan J, Camlin C, Al-Hussaini TK, Butrick E, Meyer C. A comparative study of the non-pneumatic anti-shock garment for the treatment of obstetric hemorrhage in Egypt. Int J Gynaecol Obstet. 2010 Apr;109(1):20-4. doi: 10.1016/j.ijgo.2009.11.016. Epub 2010 Jan 22. — 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 Apr;113(4):424-9. — View Citation
Miller S, Hensleigh P. Non-pneumatic Anti-shock Garment for Obstetric Hemorrhage. Chapter 14 in: (eds) B-Lynch, C, Keith, L, LaLonde, A, Karoshi, M. An International Federation of Obstetrics and Gynecology (FIGO) Book Postpartum Hemorrhage: New Thoughts, New Approaches. London, UK: Sapiens Publications; 2006. p. 136-46.
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, Ojengbede A, Turan JM, Ojengbede O, Butrick E, Hensleigh P. Anti-Shock Garments for Obstetric Hemorrhage. Current Women's Health Reviews. 2007;3(1):3-11.
Miller S, Ojengbede O, Turan JM, Morhason-Bello IO, Martin HB, Nsima D. A comparative study of the non-pneumatic anti-shock garment for the treatment of obstetric hemorrhage in Nigeria. Int J Gynaecol Obstet. 2009 Nov;107(2):121-5. doi: 10.1016/j.ijgo.2009.06.005. Epub 2009 Jul 22. — 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 haemorrhage in Egypt. Glob Public Health. 2007;2(2):110-24. doi: 10.1080/17441690601012536. — View Citation
Miller S, Turan JM, Ojengbede A, Ojengbede O, Fathalla MF, Morhason-Bello IO, et al. The pilot study of the non-pneumatic anti-shock garment (NASG) in women with severe obstetric hemorrhage: Combined results from Egypt and Nigeria. Int J Gynaecol Obstet. 2006;94(Supplement 2):S154-6.
Morris, J., Meyer, C., Fathalla, MF, Youssif, MM, Al-Hussaini, TK, Camlin, C., Miller, S. Treating Uterine Atony with the NASG in Egypt. African Journal of Midwifery and Women's Health 5(1):37-42, 2011
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. — View Citation
Ojengbede OA, Morhason-Bello IO, Galadanci H, Meyer C, Nsima D, Camlin C, Butrick E, Miller S. Assessing the role of the non-pneumatic anti-shock garment in reducing mortality from postpartum hemorrhage in Nigeria. Gynecol Obstet Invest. 2011;71(1):66-72. doi: 10.1159/000316053. Epub 2010 Dec 15. — View Citation
Ojengbede, O., Galadanci, H., Morhason-Bello, IO, Nsima, D., Camlin, C., Morris, J., Butrick, E., Meyer, C., Mohammed, AI, Miller, S. The Non-pneumatic Anti-Shock Garment for Postpartum Haemorrhage in Nigeria. African Journal of Midwifery and Women's Health 5(3):135-9, 2011
Stenson, A., Lester, F., Meyer, C., Morris, J., Vargas, V., Miller, S. The Non-pneumatic Anti-Shock Garment: How Applier Strength and Body Mass Index Affect Pressure. International Journal of Gynecology and Obstetrics, 2011; 5:33-37
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. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes | during hospital stay | No | |
Secondary | Mean amount of blood loss in mL , frequency of emergency hysterectomy, time to recovery from shock. | Blood loss as measured by the blood collection drape at the RH or pad between SHF and RH. | during hospital stay | No |
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