Non-pneumatic anti-shock garment (NASG), a first-aid device to decrease maternal mortality from obstetric hemorrhage: a cluster randomized trial

Suellen Miller, Eduardo F Bergel, Alison M El Ayadi, Luz Gibbons, Elizabeth A Butrick, Thulani Magwali, Gricelia Mkumba, Christine Kaseba, N T My Huong, Jillian D Geissler, Mario Merialdi, Suellen Miller, Eduardo F Bergel, Alison M El Ayadi, Luz Gibbons, Elizabeth A Butrick, Thulani Magwali, Gricelia Mkumba, Christine Kaseba, N T My Huong, Jillian D Geissler, Mario Merialdi

Abstract

Background: Obstetric hemorrhage is the leading cause of maternal mortality. Using a cluster randomized design, we investigated whether application of the Non-pneumatic Anti-Shock Garment (NASG) before transport to referral hospitals (RHs) from primary health care centers (PHCs) decreased adverse outcomes among women with hypovolemic shock. We hypothesized the NASG group would have a 50% reduction in adverse outcomes.

Methods and findings: We randomly assigned 38 PHCs in Zambia and Zimbabwe to standard obstetric hemorrhage/shock protocols or the same protocols plus NASG prior to transport. All women received the NASG at the RH. The primary outcomes were maternal mortality; severe, end-organ failure maternal morbidity; and a composite mortality/morbidity outcome, which we labeled extreme adverse outcome (EAO). We also examined whether the NASG contributed to negative side effects and secondary outcomes. The sample size for statistical power was not reached; of a planned 2400 women, 880 were enrolled, 405 in the intervention group. The intervention was associated with a non-significant 46% reduced odds of mortality (OR 0.54, 95% CI 0.14-2.05, p = 0.37) and 54% reduction in composite EAO (OR 0.46, 95% CI 0.13-1.62, p = 0.22). Women with NASGs recovered from shock significantly faster (HR 1.25, 95% CI 1.02-1.52, p = 0.03). No differences were observed in secondary outcomes or negative effects. The main limitation was small sample size.

Conclusions: Despite a lack of statistical significance, the 54% reduced odds of EAO and the significantly faster shock recovery suggest there might be treatment benefits from earlier application of the NASG for women experiencing delays obtaining definitive treatment for hypovolemic shock. As there are no other tools for shock management outside of referral facilities, and no safety issues found, consideration of NASGs as a temporizing measure during delays may be warranted. A pragmatic study with rigorous evaluation is suggested for further research.

Trial registration: ClinicalTrials.gov NCT00488462.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Non-pneumatic Anti-Shock Garment (NASG) Photo.
Figure 1. Non-pneumatic Anti-Shock Garment (NASG) Photo.
A model in an NASG.
Figure 2. Schematic of the NASG.
Figure 2. Schematic of the NASG.
This figure shows an opened NASG. The articulated leg segments (1, 2, 3) are attached to the pelvic segment (4), and the abdominal segments (5, 6) contain a foam ball for extra pressure.
Figure 3. Cluster Randomized Trial Design.
Figure 3. Cluster Randomized Trial Design.

References

    1. Lozano R, Wang H, Foreman KJ, Rajaratnam JK, Naghavi M, et al. (2011) Progress towards Millennium Development Goals 4 and 5 on maternal and child mortality: an updated systematic analysis. Lancet 378: 1139–1165.
    1. WHO (2012) WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: World Health Organization. 42 p.
    1. Lalonde A (2012) Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet 117: 108–118.
    1. Mobeen N, Durocher J, Zuberi N, Jahan N, Blum J, et al. (2010) Use of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage during home deliveries in Pakistan: a randomised placebo-controlled trial. British Journal of Obstetrics and Gynaecology 118: 353–361.
    1. Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, et al. (2006) Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet 368: 1248–1253.
    1. McCarthy J, Maine D (1992) A framework for analyzing the determinants of maternal mortality. Stud Fam Plann 23: 23–33.
    1. Ransom EI, Yinger NV (2002) Making Motherhood Safer: Overcoming Obstacles on the Pathway to Care.: Population Reference Bureau.
    1. Lester F, Stenson A, Meyer C, Morris J, Vargas J, et al. (2011) Impact of the Non-pneumatic Anti-shock Garment on pelvic blood flow in healthy postpartum women. Am J Obstet Gynecol 204: 409e401–405.
    1. McSwain NE (1988) Pneumatic anti-shock garment: state of the art 1988. Ann Emerg Med 17: 506–525.
    1. Stenson A, Miller S, Lester F (2012) The Mechanisms of Action of the Non-pneumatic Anti-Shock Garment (NASG). In: Arulkumaran S, Karoshi M, L.G K, Lalonde A, B-Lynch C, editors. A Comprehensive Textbook of Postpartum Hemorrhage: An Essential Clinical Reference for Effective Management. 2nd ed. UK: Sapiens Publications.
    1. McSwain MJ, McSwain NE (2000) Pneumatic antishock garment: state of the art at the turn of the century. Trauma 2: 63–75.
    1. Hauswald M, Greene ER (1986) Aortic blood flow during sequential MAST inflation. Ann Emerg Med 15: 1297–1299.
    1. Hauswald M, Greene ER (2003) Regional blood flow after pneumatic anti-shock garment inflation. Prehosp Emerg Care 7: 225–228.
    1. Hensleigh PA (2002) Anti-shock garment provides resuscitation and haemostasis for obstetric haemorrhage. BJOG 109: 1377–1384.
    1. Pelligra R (1994) Non-pneumatic antishock garment use. Emergency: 53–56.
    1. O’Connor RE, Domeier RM (1997) An evaluation of the pneumatic anti-shock garment (PASG) in various clinical settings. Prehosp Emerg Care 1: 36–44.
    1. Christensen KS (1986) Pneumatic antishock garments (PASG): do they precipitate lower-extremity compartment syndromes? J Trauma 26: 1102–1105.
    1. Dickinson K, Roberts I (2000) Medical anti-shock trousers (pneumatic anti-shock garments) for circulatory support in patients with trauma. Cochrane Database Syst Rev: CD001856.
    1. Miller S, Fathalla MM, Ojengbede OA, Camlin C, Mourad-Youssif M, et al. (2010) Obstetric hemorrhage and shock management: using the low technology Non-pneumatic Anti-Shock Garment in Nigerian and Egyptian tertiary care facilities. BMC Pregnancy Childbirth 10: 64.
    1. Miller S, Fathalla MM, Youssif MM, Turan J, Camlin C, et al. (2010) A comparative study of the non-pneumatic anti-shock garment for the treatment of obstetric hemorrhage in Egypt. Int J Gynaecol Obstet 109: 20–24.
    1. Miller S, Hamza S, Bray E, Gipson R, Nada K, et al. (2006) First aid for obstetrical haemorrhage: the pilot study of the non-pneumatic anti-shock garment (NASG) in Egypt. BJOG 113: 424–429.
    1. Miller S, Ojengbede O, Turan JM, Morhason-Bello IO, Martin HB, et al. (2009) A comparative study of the non-pneumatic anti-shock garment for the treatment of obstetric hemorrhage in Nigeria. Int J Gynaecol Obstet 107: 121–125.
    1. Miller S, Turan JM, Dau K, Fathalla M, Mourad M, et al. (2007) 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 2: 110–124.
    1. Sutherland T, Downing J, Miller S, Bishai D, Butrick E, et al... (2013) Use of the non-pneumatic anti-shock garment (NASG) for life-threatening obstetric hemorrhage: A cost-effectiveness analysis in Egypt and Nigeria. PLoS ONE.
    1. WHO (2012) WHO recommendations for the prevention and treatment of postpartum haemorrhage: Evidence base. Geneva: World Health Organization. 278 p.
    1. (2007) Zambia Demographic and Health Survey. Calverton, MD: Central Statistical Office, Lusaka, Zambia; Ministry of Health, Lusaka, Zambia; Tropical Diseases Research Centre, Ndola, Zambia; University of Zambia, Lusaka, Zambia.
    1. (2010–2011) Zimbabwe Demographic and Health Survey. Calverton, MD: Zimbabwe National Statistics Agency.
    1. Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, et al. (2012) Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials 13: 120.
    1. The Clinician’s Ultimate Reference (2010) Mean Arterial Pressure.
    1. Mantel GD, Buchmann E, Rees H, Pattinson RC (1998) Severe acute maternal morbidity: a pilot study of a definition for a near-miss. BJOG, 105 985–990.
    1. Mitra B, Fitzgerald M, Chan J (2013) The utility of a shock index>/ = 1 as an indication for pre-hospital oxygen carrier administration in major trauma. Injury.
    1. Hensleigh P, Ojengbede O, Miller S, Morhason-Bello IO, Fabamwo OA (2005) Non-pneumatic Anti Shock Garment Resuscitation in Patients with Post Partum Hemorrhage, Abstract # 029 Presented at the Society of Gynaecology and Obstetrics of Nigeria (SOGON) Annual Conference. Tropical Journal of Obstetrics and Gynaecology 22: S14.
    1. Donner A, Klar N (2000) Design and Analysis of Cluster Randomisation Trials: In Health Research: Oxford University Press. 178 pages p.
    1. Nixon RM, Thompson SG (2003) Baseline adjustments for binary data in repeated cross-sectional cluster randomized trials. Stat Med 22: 2673–2692.
    1. Miller S, Sloan NL, Winikoff B, Langer A, Fikree FF (2003) Where is the “E” in MCH? The need for an evidence-based approach in safe motherhood. J Midwifery Womens Health 48: 10–18.
    1. Campbell OM, Graham WJ (2006) Strategies for reducing maternal mortality: getting on with what works. Lancet 368: 1284–1299.
    1. West KPJ, Katz J, Khatry SK, LeClerq SC, Pradhan EK, et al. (1999) Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group. BMJ 318: 570–575.
    1. Altman D, Carroli G, Duley L, Farrell B, Moodley J, et al. (2002) Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet 359: 1877–1890.
    1. Manandhar DS, Osrin D, Shrestha BP, Mesko N, Morrison J, et al. (2004) Effect of a participatory intervention with women’s groups on birth outcomes in Nepal: cluster-randomised controlled trial. Lancet 364: 970–979.
    1. Jokhio AH, Winter HR, Cheng KK (2005) An intervention involving traditional birth attendants and perinatal and maternal mortality in Pakistan. N Engl J Med 352: 2091–2099.
    1. Goudar SS, Chakraborty H, Edlavitch SA, Naik VA, Bellad MB, et al. (2008) Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol. J Matern Fetal Neonatal Med 21: 559–564.
    1. Fathalla MF, Mourad-Youssif MM, Meyer C, Camlin C, Turan J, et al... (2011) Non-Atonic Obstetric Haemorrhage: Effectiveness of the Non-pneumatic Anti-Shock Garment in Egypt. ISRN Obstet Gynecol 2011.
    1. Morris J, Meyer C, Fathalla MF, Youssif MM, Al-Hussaini TK, et al. (2011) Treating Uterine Atony with the Non-pneumatic Anti-Shock Garment in Egypt. Afr J Midwifery Womens Health 5: 37–42.
    1. Turan J, Ojengbede O, Fathalla M, Mourad-Youssif M, Morhason-Bello IO, et al. (2011) 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) 20: 91–98.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera