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      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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          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

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          Most cited references21

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          An intervention involving traditional birth attendants and perinatal and maternal mortality in Pakistan.

          There are approximately 4 million neonatal deaths and half a million maternal deaths worldwide each year. There is limited evidence from clinical trials to guide the development of effective maternity services in developing countries. We performed a cluster-randomized, controlled trial involving seven subdistricts (talukas) of a rural district in Pakistan. In three talukas randomly assigned to the intervention group, traditional birth attendants were trained and issued disposable delivery kits; Lady Health Workers linked traditional birth attendants with established services and documented processes and outcomes; and obstetrical teams provided outreach clinics for antenatal care. Women in the four control talukas received usual care. The primary outcome measures were perinatal and maternal mortality. Of the estimated number of eligible women in the seven talukas, 10,114 (84.3 percent) were recruited in the three intervention talukas, and 9443 (78.7 percent) in the four control talukas. In the intervention group, 9184 women (90.8 percent) received antenatal care by trained traditional birth attendants, 1634 women (16.2 percent) were seen antenatally at least once by the obstetrical teams, and 8172 safe-delivery kits were used. As compared with the control talukas, the intervention talukas had a cluster-adjusted odds ratio for perinatal death of 0.70 (95 percent confidence interval, 0.59 to 0.82) and for maternal mortality of 0.74 (95 percent confidence interval, 0.45 to 1.23). Training traditional birth attendants and integrating them into an improved health care system were achievable and effective in reducing perinatal mortality. This model could result in large improvements in perinatal and maternal health in developing countries. Copyright 2005 Massachusetts Medical Society.
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            Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

            Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.
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              Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

              Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                23 October 2013
                : 8
                : 10
                : e76477
                Affiliations
                [1 ]Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America
                [2 ]Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
                [3 ]Department of Obstetrics and Gynecology, University of Zimbabwe, Harare, Zimbabwe
                [4 ]Department of Obstetrics and Gynecology, University Teaching Hospital, Lusaka, Zambia
                [5 ]The Department of Reproductive Health and Research of the United Nations Development Programme/United Nations Population Fund/United Nations Children’s Fund/World Health Organization/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland
                Assiut University Hospital, Egypt
                Author notes

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

                Conceived and designed the experiments: SM. Analyzed the data: EFB AE LG. Wrote the paper: SM EFB LG EAB AE. Supervised the study, provided administrative & technical support and revised drafts: TM GM CK. Principal investigator for the study and oversaw implementation of the study and interpreted results: SM. Oversaw database creation management: EFB. Supervised and study and cleaned the data: EAB. Involved in literature searches, figure development and data cleaning: JG. Helped acquire funding: MM. Created figures & tables, data cleaning and data interpretation: AE. Database management: NTMH.

                Article
                PONE-D-13-21141
                10.1371/journal.pone.0076477
                3806786
                24194839
                941be8f4-786c-45ea-b5d8-2e46c53de1ad
                Copyright @ 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 15 May 2013
                : 21 August 2013
                Page count
                Pages: 12
                Funding
                The project described was supported by Grant Number R01HD053129 from the National Institutes Of Child Health And Human Development. Additional funding was provided by the Bill and Melinda Gates Foundation, Grant #48541. Technical and financial support was provided by the United Nations Development Programme/United Nations Population Fund/United Nations Children’s Fund/World Health Organization (WHO)/World Bank Special programme of research, development and research training in human reproduction (HRP/WHO). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes Of Child Health And Human Development or the National Institutes of Health, the Bill and Melinda Gates Foundation, or the World Health Organization. Other than EFB, NTMH and MM, who are authors, HRP/WHO staff had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The remaining funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
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