Dataset Information

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

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.

SUBMITTER: Miller S

PROVIDER: S-EPMC3806786 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

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

Miller Suellen S Bergel Eduardo F EF El Ayadi Alison M AM Gibbons Luz L Butrick Elizabeth A EA Magwali Thulani T Mkumba Gricelia G Kaseba Christine C Huong N T My NT Geissler Jillian D JD Merialdi Mario M

PloS one 20131023 10

<h4>Background</h4>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.<h4>Methods and findings</h4>We randomly assigned 38 PHCs in Zambia and ...[more]

PMID: 24194839

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Project description:BackgroundObstetric hemorrhage (OH), which includes hemorrhage from multiple etiologies during pregnancy, childbirth, or postpartum, is the leading cause of maternal mortality and accounts for one-quarter of global maternal deaths. The Non-pneumatic Anti-Shock Garment (NASG) is a first-aid device for obstetric hemorrhage that can be applied for post-partum/post miscarriage and for ectopic pregnancies to buy time for a woman to reach a health care facility for definitive treatment. Despite successful field trials, and endorsement by safe motherhood organizations and the World Health Organization (WHO), scale-up has been slow in some countries. This qualitative study explores contextual factors affecting uptake.MethodsFrom March 2013 to April 2013, we conducted 13 key informant interviews across four countries with a large burden of maternal mortality that had achieved varying success in scaling up the NASG: Ethiopia, India, Nigeria, and Zimbabwe. These key informants were health providers or program specialists working with the NASG. We applied a health policy analysis framework to organize the results. The framework has five domains: attributes of the intervention, attributes of the implementers, delivery strategy, attributes of the adopting community, the socio-political context, and the research context.ResultsThe interviews from our study found that relevant facilitators for scale-up are the simplicity of the device, local and international champions, well-developed training sessions, recommendations by WHO and the International Federation of Gynecology and Obstetrics, and dissemination of NASG clinical trial results. Barriers to scaling up the NASG included limited health infrastructure, relatively high upfront cost of the NASG, initial resistance by providers and policy makers, lack of in-country champions or policy makers advocating for NASG implementation, inadequate return and exchange programs, and lack of political will.ConclusionsThere was a continuum of uptake ranging in both speed and scale. Ethiopia while not the first country to use the NASG has the most rapid scale-up, followed by Nigeria, then India, and finally Zimbabwe. Increasing the coverage of the NASG will require collaboration with local NASG champions, greater NASG awareness among clinicians and policymakers, as well as stronger political will and advocacy.

Project description:Non-pneumatic Anti-Shock Garment (NASG) is a lightweight, reusable first aid compression device that squeezes blood from the lower extremities and centralizes blood circulation to vital organs of the body. Postpartum hemorrhage followed by severe preeclampsia/eclampsia is the leading primary cause of maternal death (A reduction in extreme maternal adverse outcomes and faster recovery from shock are more likely to occur with earlier NASG intervention. The median blood loss reduced by half when the NASG was used for obstetric hemorrhage management, which was associated with significantly reduced maternal mortality among the most severe cases. To estimate the pooled prevalence of NASG utilization and its predictors in Ethiopia. Appropriate and comprehensive searches of PubMed, MEDLINE, EMBASE, Google Scholar, HINARI, and Scopus were performed. The electronic literature search was last performed on November 18/2023. All observational study designs were eligible for this SRMA. All cross sectional studies reporting the prevalence/proportion of NASG utilization for obstetric hemorrhage management among obstetric care providers and associated factors were included in this SRMA. Primary studies lacking the outcome of interest were excluded from the SRMA. The extracted Microsoft Excel spreadsheet data were imported into STATA software version 17 (STATA Corporation, Texas, USA) for analysis. A random-effects model was used to estimate the pooled prevalence of NASG utilization among obstetric care providers in Ethiopia. The Cochrane Q-test and I2 statistics were computed to assess the heterogeneity among the studies included in the SRMA. A total of 1623 articles were found by using our search strategies and seven studies comprising 2335 participants were ultimately included in the SRMA. The pooled prevalence of NASG utilization for obstetric hemorrhage in Ethiopia was 43.34% (95% CI: 35.25, 51.42%). The findings of this subgroup analysis by sample size showed that the pooled prevalence of NASG utilization for obstetric hemorrhage was greater in studies with sample sizes of less than the mean sample size (48.6%; 95% CI: 32.34, 64.86%). Receiving training (AOR = 3.88, 95% CI: 2.08-5.37), having good knowledge (AOR = 1.99, 95% CI: 1.28-3.16), positive attitude (AOR = 2.16, 95% CI: 1.62-2.75) and having available NASGs in the facility (AOR = 4.89, 95%CI: 2.88-8.32) were significantly associated with the use of NASGs for obstetric hemorrhage management. The level of NASG utilization for obstetric hemorrhage in Ethiopia is low. Receiving training, good knowledge, positive attitudes and availability of NASG were significantly associated with the utilization of NASG. Therefore, policy makers and other stakeholders should emphasize enhancing the knowledge and attitudes of obstetric care providers through continuous support and training. At the same time, they should work strictly in providing devices for all the health facilities.

Project description:BackgroundA disproportionate burden of maternal deaths occurs in low- and middle-income countries (LMICs), and obstetric hemorrhage (OH) is a leading cause of excess mortality. In Zambia, most of maternal deaths are directly caused by OH. The Non-Pneumatic Anti-Shock Garment (NASG) is a first aid tool that uses compression to the abdomen and lower body to stop and reverse hypovolemic shock secondary to OH. We describe the process and experiences introducing the NASG into the Zambia public health system to encourage the development of national policies, clinical guidelines, and implementation plans that feature the NASG.MethodsWe conducted an observational study of NASG introduction to 143 public health facilities in Northern Province, Zambia, organizing observations into the five dimensions of the RE-AIM evaluation framework: reach, effectiveness, adoption, implementation, and maintenance. The NASG was introduced in August 2019, and the introduction was evaluated for 18 months. Data on healthcare worker training and mentorship, cases where NASG was used, and NASG availability and use during the study period were collected and analyzed.ResultsThe NASG was successfully introduced and integrated into the Zambia public health system, and appropriately used by healthcare workers when responding to cases of OH. Sixteen months after NASG introduction, NASGs were available and functional at 99% of study sites and 88% reported ever using a NASG. Of the 68 cases of recorded OH where a NASG was applied, 66 were confirmed as clinically appropriate, and among cases where shock index (SI) could be calculated, 59% had SI ≥ 0.9. Feedback from healthcare providers revealed that 97% thought introducing the NASG was a good decision, and 92% felt confident in their ability to apply the NASG after initial training. The RE-AIM average for this study was 0.65, suggesting a public health impact that is not equivocal, and that NASG introduction had a positive population-based effect.ConclusionsA successful NASG demonstration took place over the course of 18 months in the existing health system of Northern Province, Zambia, suggesting that incorporation of NASG into the standard of care for obstetric emergency in the Zambia public sector is feasible and can be maintained without external support.

Dataset Information

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

Background

Methods and findings

Conclusions

Trial registration

Publications

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

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