Obstetric hemorrhage and shock management: using the low technology Non-pneumatic Anti-Shock Garment in Nigerian and Egyptian tertiary care facilities

Abstract Background Obstetric hemorrhage is the leading cause of maternal mortality globally. The Non-pneumatic Anti-Shock Garment (NASG) is a low-technology, first-aid compression device which, when added to standard hypovolemic shock protocols, may improve outcomes for women with hypovolemic shock secondary to obstetric hemorrhage in tertiary facilities in low-resource settings. Methods This study employed a pre-intervention/intervention design in four facilities in Nigeria and two in Egypt. Primary outcomes were measured mean and median blood loss, severe end-organ failure morbidity (renal failure, pulmonary failure, cardiac failure, or CNS dysfunctions), mortality, and emergency hysterectomy for 1442 women with ≥750 mL blood loss and at least one sign of hemodynamic instability. Comparisons of outcomes by study phase were assessed with rank sum tests, relative risks (RR), number needed to treat for benefit (NNTb), and multiple logistic regression. Results Women in the NASG phase (n = 835) were in worse condition on study entry, 38.5% with mean arterial pressure <60 mmHg vs. 29.9% in the pre-intervention phase (p = 0.001). Despite this, negative outcomes were significantly reduced in the NASG phase: mean measured blood loss decreased from 444 mL to 240 mL (p < 0.001), maternal mortality decreased from 6.3% to 3.5% (RR 0.56, 95% CI 0.35-0.89), severe morbidities from 3.7% to 0.7% (RR 0.20, 95% CI 0.08-0.50), and emergency hysterectomy from 8.9% to 4.0% (RR 0.44, 0.23-0.86). In multiple logistic regression, there was a 55% reduced odds of mortality during the NASG phase (aOR 0.45, 0.27-0.77). The NNTb to prevent either mortality or severe morbidity was 18 (12-36). Conclusion Adding the NASG to standard shock and hemorrhage management may significantly improve maternal outcomes from hypovolemic shock secondary to obstetric hemorrhage at tertiary care facilities in low-resource settings

Can the Non-pneumatic Anti-Shock Garment (NASG) reduce adverse maternal outcomes from postpartum hemorrhage? Evidence from Egypt and Nigeria

<p>Abstract</p> <p>Background</p> <p>Postpartum hemorrhage (PPH) is the leading cause of maternal mortality and severe maternal morbidity. The Non-pneumatic Anti-Shock Garment (NASG), a first-aid lower-body compression device, may decrease adverse outcomes from obstetric hemorrhage. This article is the first to report the effect of the NASG for PPH.</p> <p>Methods</p> <p>This pre-intervention/NASG study of 854 women was conducted in four referral facilities in Nigeria and two in Egypt between 2004-2008. Entry criteria were women with PPH due to uterine atony, retained placenta, ruptured uterus, vaginal or cervical lacerations or placenta accreta with estimated blood loss of ≥ 750 mL and one clinical sign of shock. Differences in demographics, conditions on study entry, treatment and outcomes were examined. The Wilcoxon rank-sum test and relative risks with 95% confidence intervals were calculated for primary outcomes - measured blood loss, emergency hysterectomy, mortality, morbidity (each individually), and a combined variable, "adverse outcomes", defined as severe morbidity and mortality. A multiple logistic regression model was fitted to test the independent association between the NASG and the combined severe morbidity and mortality outcome.</p> <p>Results</p> <p>Measured blood loss decreased by 50% between phases; women experienced 400 mL of median blood loss after study entry in the pre-intervention and 200 mL in the NASG phase (p < 0.0001). As individual outcomes, mortality decreased from 9% pre-intervention to 3.1% in the NASG phase (RR 0.35, 95% CI 0.19-0.62); severe morbidity decreased from 4.2% to 1%, in the NASG phase (RR 0.24, 95% CI 0.09-0.67). As a combination, "adverse outcomes," decreased from 12.8% to 4.1% in the NASG phase (RR 0.32, 95% CI 0.19-0.53). In a multiple logistic regression model, the NASG was associated with the combined outcome of severe maternal morbidity and mortality (OR 0.42, 95% CI 0.18-0.99).</p> <p>Conclusion</p> <p>In this non-randomized study, in which bias is inherent, the NASG showed promise for reducing blood loss, emergency hysterectomy, morbidity and mortality associated with PPH in referral facilities in Egypt and Nigeria.</p

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tween phases. Women experienced 350 ml of median blood loss after study entry in the pre-intervention and 50 ml in the NASG phase (p ! 0.0001). Mortality decreased from 18% preintervention to 6% in the NASG phase (RR = 0.31, 95% CI 0.15-0.64, p = 0.0007). In a multiple logistic regression model, the NASG was associated with reduced mortality (odds ratio 0.30; 95% CI 0. 13-0.68, p = 0.004). Conclusion: The NASG shows promise for reducing mortality from PPH in referral facilities in Nigeria

Use of the Non-Pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage: A Cost-Effectiveness Analysis in Egypt and Nigeria

OBJECTIVE: To assess the cost-effectiveness of a non-pneumatic anti-shock garment (NASG) for obstetric hemorrhage in tertiary hospitals in Egypt and Nigeria. METHODS: We combined published data from pre-intervention/NASG-intervention clinical trials with costs from study sites. For each country, we used observed proportions of initial shock level (mild: mean arterial pressure [MAP] >60 mmHg; severe: MAP ≤60 mmHg) to define a standard population of 1,000 women presenting in shock. We examined three intervention scenarios: no women in shock receive the NASG, only women in severe shock receive the NASG, and all women in shock receive the NASG. Clinical data included frequencies of adverse health outcomes (mortality, severe morbidity, severe anemia), and interventions to manage bleeding (uterotonics, blood transfusions, hysterectomies). Costs (in 2010 international dollars) included the NASG, training, and clinical interventions. We compared costs and disability-adjusted life years (DALYs) across the intervention scenarios. RESULTS: For 1000 women presenting in shock, providing the NASG to those in severe shock results in decreased mortality and morbidity, which averts 357 DALYs in Egypt and 2,063 DALYs in Nigeria. Differences in use of interventions result in net savings of $9,489 in Egypt (primarily due to reduced transfusions) and net costs of$6,460 in Nigeria, with a cost per DALY averted of $3.13. Results of providing the NASG for women in mild shock has smaller and uncertain effects due to few clinical events in this data set. CONCLUSION: Using the NASG for women in severe shock resulted in markedly improved health outcomes (2–2.9 DALYs averted per woman, primarily due to reduced mortality), with net savings or extremely low cost per DALY averted. This suggests that in resource-limited settings, the NASG is a very cost-effective intervention for women in severe hypovolemic shock. The effects of the NASG for mild shock are less certain

Unit costs by study site, 2010 (Int$)[1].

<p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282-Hogan1" target="_blank">[1]</a>. Costs were adjusted from local currency to international dollar with most recently available purchasing power parity (PPP) factors of 2 for Egypt and 78 for Nigeria.²¹ Refer to <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282.s001" target="_blank">Technical appendix S1</a> for a detailed explanation.</p><p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282-United1" target="_blank">[2]</a>. Differences in hysterectomy cost were investigated and confirmed with local investigators.</p><p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282-Kidney1" target="_blank">[3]</a>. Oxytocin cost from PATH report²⁸ for price per dose of 0.55 USD for an occasional purchase, medium volume.

[4]. Training costs were standardized across project sites and include provider time during the training.

[5]. Cost includes purchase price of 295 USD based on 40 uses.</p

Image of nurse applying non-pneumatic shock garment (NASG) to study patient in Nigeria^*.

<p>* Both the provider and patient have given informed consent, as outlined in the PLOS consent form, to publication of their photograph.</p

Clinical trial results for women with shock from maternal hemorrhage, by country, shock severity, and use or non-use of the non-pneumatic anti-shock garment (NASG).

<p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282-Hogan1" target="_blank">[1]</a>. 450 mls per unit <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282-United1" target="_blank">[2]</a>. Uterine atony only <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0062282#pone.0062282-Kidney1" target="_blank">[3]</a>. Oxytocin and Ergometrine.</p

Calculated mortality, morbidity, disability-adjusted life years, cost, and cost-effectiveness for 1,000 women with severe or mild shock[1] from maternal hemorrhage, by intervention scenario.

<p>1. Proportion of cohort with severe shock (MAP<60) is 18% for Egypt¹⁶ and 72%¹⁵ for Nigeria (from clinical trial, combining pre and post trial periods).</p><p>2."Difference" is versus prior row (scenario). Negative values in "difference" columns are desirable — disease burden or cost averted.</p><p>3. "Dominant" means cheaper and better health outcomes than previous intervention scenario. "Dominated" means more costly and worse outcomes than previous scenario.</p><p>4. Results for "NASG only if MAP <60" are more stable than for the incremental effect of "NASG for all", due to the small number of clinical events for mild shock group in original trials; see text.</p