Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe

Hemorrhage Clinical Trial

— NASG  

Official title:

Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488462
• Other study ID #: 1R01HD053129-01A1
• Secondary ID: 5R01HD053129-03
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: January 16, 2015
• Start date: October 2007
• Est. completion date: May 2012

Study information

• Verified date: January 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics CommitteeZimbabwe: Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is a cluster randomized controlled trial to examine the effects of NASG application as a first-aid device at the SHFs before transfer to Referral Hospitals (RHs).

The first step will include start-up activities and formative data collection, including facility staff training in data collection, how to collect blood in the closed-end blood collection drape, and in an evidence-based standardized clinical protocol for obstetric hemorrhage prevention and hemorrhage and shock management. Next will be a period of baseline data collection at the RHs and SHFs, during which clinical and demographic data will be collected from women diagnosed with obstetric hemorrhage and shock. After this baseline data collection period, we will introduce the study intervention, initially at the RHs and then at SHFs.

The intervention will include: review of study protocol differences between baseline and the NASG-intervention phases, provision of the NASG, detailed training on the use of NASG for health care providers and staff, as well as on-site support and supervision for use of the NASG. After the RH providers are fully trained and have become proficient in NASG use, SHFs will be randomized into 19 intervention and 19 control facilities. Intervention SHFs will receive the NASG training described above, while control SHFs will receive a refresher training on the topics included in the baseline training.

The final step will be three years of NASG-intervention data collection at the RHs and the SHFs on women diagnosed with obstetric hemorrhage and shock on the same outcomes collected in the baseline period. A total of approximately 2,340 women from the SHFs will be included in the NASG-intervention data collection phase of the cluster randomized trial: 1,170 women in the intervention group and 1,170 women in the control group.

Recruitment information / eligibility

• 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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Hypovolemic Shock
• Shock

Intervention

Device:
• non-pneumatic anti-shock garment
In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.

Locations

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

Sponsors (6)

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

Countries where clinical trial is conducted

Zambia,  Zimbabwe, 

References & Publications (19)

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

Outcome

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

External Links

•   Information and updates on current trials using the Life Wrap (NASG) for obstetric hemorrhage in low resource settings.
•   Safe Motherhood Program details at University of California, San Francisco