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Understanding the colonization of Pseudomonas aeruginosa (P. aeruginosa) in healthy humans is useful for future prevention and treatment of P. aeruginosa infection. This study aimed to investigate the prevalence and risk factors of of P. aeruginosa colonization in healthy humans. At the same time, the virulence of the isolated P. aeruginosa was also studied. In the study, 609 Vietnamese volunteers (310 females and 299 males, age range of 2 to 73 years), who had no acute infection or disease symptoms participated at the time of sample collection. Samples were taken from the throat, nostrils, and outer ears. P. aeruginosa was found in 19 participants (3.12%, 95% CI: 0.017–0.045), mainly from the throat (11/19, 57.89%). Participants with a history of sinusitis were 11.57 times more likely to be colonized with P. aeruginosa than participants without a history of sinusitis (OR: 11.57, 95% CI: 4.08–32.76, p-value < 0.0001, Fisher’s Exact test). Age and sex were not significantly associated with P. aeruginosa colonization. Among 16 P. aeruginosa isolates used in virulence tests, 100% (16/16) were positive for the synthesis of biofilm, pyocyanin, and siderophores; 93.75% (15/16) isolates were positive for the synthesis of gelatinase and protease; and 50% (8/16) isolates were positive for lipase. There were no differences in the pattern and range of virulence factors of P. aeruginosa isolates taken from participants with and without sinusitis history. P. aeruginosa colonized 3.12% of participants, and its presence was associated with sinusitis history.

In Vietnam, the State’s power is unified, agencies shall assign, coordinate and control each other in the exercises of the legislative, executive, and judicial powers. This is necessary to prevent abuse of power and ensure the state’s power. The Constitution 1946 was written by Ho Chi Minh (1890 -1969) and created a mechanism and foundation to control the state’s power in Vietnam. Nearly, in the Constitution 2013, the issue of controlling state power is recorded. The assignment and control are reflected in the assignment of the scope of power to each state agency. From the approach of philosophical, social philosophy, and political philosophy, through research and analysis documents in Ho Chi Minh Complete Collection; of previous researchers and policies, legal of Vietnam’s Government on control of the state's power and lessons for Vietnam today. The result shows that Ho Chi Minh’s thought on controlling power has shown the basic contents related to asserting that the power owner belongs to the people and focusing on supervision; use the Constitution to limit state power. The article also gives experiences when studying Ho Chi Minh's thoughts on state power control over Vietnam today.

An interrupted time series with a parallel control group (ITS-CG) design is a powerful quasi-experimental design commonly used to evaluate the effectiveness of an intervention, on accelerating uptake of useful public health products, and can be used in the presence of regularly collected data. This paper illustrates how a segmented Poisson model that utilizes general estimating equations (GEE) can be used for the ITS-CG study design to evaluate the effectiveness of a complex social accountability intervention on the level and rate of uptake of modern contraception. The intervention was gradually rolled-out over time to targeted intervention communities in Ghana and Tanzania, with control communities receiving standard of care, as per national guidelines. Two ITS GEE segmented regression models are proposed for evaluating of the uptake. The first, a two-segmented model, fits the data collected during pre-intervention and post-intervention excluding that collected during intervention roll-out. The second, a three-segmented model, fits all data including that collected during the roll-out. A much simpler difference-in-difference (DID) GEE Poisson regression model is also illustrated. Mathematical formulation of both ITS-segmented Poisson models and that of the DID Poisson model, interpretation and significance of resulting regression parameters, and accounting for different sources of variation and lags in intervention effect are respectively discussed. Strengths and limitations of these models are highlighted. Segmented ITS modelling remains valuable for studying the effect of intervention interruptions whether gradual changes, over time, in the level or trend in uptake of public health practices are attributed by the introduced intervention.Trial Registration: The Australian New Zealand Clinical Trials registry.Trial registration number: ACTRN12619000378123.Trial Registration date: 11-March-2019.

Pseudomonas aeruginosa (P. aeruginosa) is one of the most concerning pathogens due to its multidrug resistance. P. aeruginosa can be a part of the normal commensal flora of humans but can also cause a wide range of infections. In this study, we investigated the prevalence of commensal P. aeruginosa in 609 Vietnamese participants (310 females and 299 males, age range of 2 to 73 years) who had no acute infection or disease symptoms at the time of sample collection. Samples were taken from the throat, naris and outer ears. As a result, 19 were positive with P. aeruginosa (3.12%, 95% CI: 0.017-0.045) which came mostly from throat (11/19, 57.89%). Participants with a history of sinusitis were 11.57 times more likely to be colonized with P. aeruginosa than participants without a history of sinusitis (OR: 11.57, 95% CI: 4.08-32.76, p-value< 0.0001). Age and gender were not significantly associated with P. aeruginosa colonization. The commensal P. aeruginosa isolates were tested for biofilm formation, pyocyanin, siderophore, lipase, protease and gelatinase production. Among 16 P. aeruginosa isolates used for these tests, 100% (16/16) were positive for biofilm, pyocyanin and siderophores; 93.75% (15/16) isolates were positive for gelatinase and protease; and 50% (8/16) isolates were positive for lipase. There were no differences in the pattern and range of virulence factors of P. aeruginosa isolates taken from participants with and without sinusitis history. In summary, P. aeruginosa colonized 3.12% of participants, and its presence was clearly associated with sinusitis history. Most commensal P. aeruginosa isolates can produce biofilm, pyocyanin, siderophores, gelatinase and protease.Author summaryP. aeruginosa is both a common opportunistic pathogen which causes various infections in humans, such as blood, lung, and skin infections and a commensal bacterium which can be found normal human flora. In this study, we showed that the P. aeruginosa colonized 3.12% participants and resided mostly in human throat. Interestingly, we found that people with sinusitis history were more likely to be P. aeruginosa carriers. On the other hand, age and gender did not significantly affect P. aeruginosa colonization. Most tested P. aeruginosa isolates expressed various virulence factors, including biofilm, siderophores, pyocyanin, gelatinase, protease, and lipase.

The WHO ACTION-I trial demonstrated that dexamethasone significantly reduced neonatal mortality when administered to women at risk of early preterm birth in low-resource countries. We conducted a secondary analysis to determine how these benefits can be optimised, by evaluating the effect of dexamethasone compared to placebo on newborn mortality and severe respiratory distress outcomes at different administration-to-birth intervals, and identifying the interval with the greatest benefits.The WHO ACTION-I trial was a multi-country, individually-randomised, parallel-group, double-blind, placebo-controlled trial. It was conducted in 29 hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan. Women with a viable singleton or multiple pregnancy who presented to participating hospitals at a gestational age of 26 weeks 0 days-33 weeks 6 days and who were at risk of imminent preterm birth were eligible. In this secondary analysis, 2638 women and their newborns treated with single course of dexamethasone or placebo were analysed. Multivariate logistic regression was used to assess the effect of dexamethasone versus placebo on neonatal death, stillbirth or neonatal death, and severe respiratory distress at 24 h and at 168 h, by administration-to-birth interval (from 0 through 28 days), adjusting for gestational age at first dose. We used relative risks to identify the administration-to-birth interval with the greatest benefits of dexamethasone compared to placebo on the newborn outcomes.Between 24 December 2017 and 21 November 2019, 2852 women and their 3070 babies were enrolled in the WHO ACTION-I trial; 1332 women (1464 babies) in the dexamethasone group and 1306 women (1440 babies) in the placebo group were included in this secondary analysis. Neonatal mortality risk was lower with increasing time between initiating dexamethasone and birth, achieving peak mortality reduction by days 13 and 14 and then diminishing as the interval approached 28 days, regardless of gestational age at administration. For other outcomes, the overall pattern of risk reduction extending into the second week was consistent with that of neonatal death.In women at risk of preterm birth prior to 34 weeks' gestation, the neonatal benefits of antenatal dexamethasone appear to increase with longer administration-to-birth intervals than previously thought. This knowledge can support clinical assessment and estimation of the risks of adverse preterm newborn outcomes at the time of birth, and the potential benefits of antenatal dexamethasone treatment for a known administration-to-birth interval.Bill and Melinda Gates Foundation; World Health Organization.

Background Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. Methods/design The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up). Discussion Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization’s global recommendations on ACS use. Trial registration ACTRN12617000476336. Registered on 31 March 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3488-z) contains supplementary material, which is available to authorized users.

Background: There are numerous barriers leading to a high unmet need for family planning and contraceptives (FP/C). These include limited knowledge and information, poor access to quality services, structural inefficiencies in service provision and inadequately trained and supervised health professionals. Recently, social accountability programs have shown promising results in addressing barriers to accessing sexual and reproductive health services. As a highly complex participatory process with multiple and interrelated components, steps and actors, studying social accountability poses methodological challenges. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project study protocol was developed to measure the impact of a social accountability intervention on contraceptive uptake and use and to understand the mechanisms and contextual factors that influence and generate these effects (with emphasis on health services actors and community members). Methods: CaPSAI Project is implementing a social accountability intervention where service users and providers assess the quality of local FP/C services and jointly identify ways to improve the delivery and quality of such services. In the project, a quasi-experimental study utilizing an interrupted time series design with a control group is conducted in eight intervention and eight control facilities in each study country, which are Ghana and Tanzania. A cross-sectional survey of service users and health care providers is used to measure social accountability outcomes, and a cohort of women who are new users of FP/C is followed up after the completion of the intervention to measure contraceptive use and continuation. The process evaluation utilizes a range of methods and data sources to enable a fuller description of how the findings were produced. Conclusion: This complex study design could provide researchers and implementers with the means to better measure and understand the mechanisms and contextual factors that influence social accountability processes in reproductive health, adding important findings to the evidence base.

To determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion.We conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction.We enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0001). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness (p = 0.004), headache (p = 0.03), and vomiting (p0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group (p = 0.05); overall abortion satisfaction did not differ by group (p = 0.44).Compared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects.Given that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion.

Background Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. Methods We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 μg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. Results A total of 29,645 women underwe...

BACKGROUND: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P=0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P=0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. Fil: Oladapo, Olufemi T.. Organizacion Mundial de la Salud; Argentina Fil: Vogel, Joshua P.. Organizacion Mundial de la Salud; Argentina Fil: Piaggio, Gilda. Organizacion Mundial de la Salud; Argentina Fil: Nguyen, My-Huong. Organizacion Mundial de la Salud; Argentina Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Metin Gülmezoglu, A.. Organizacion Mundial de la Salud; Argentina Fil: Bahl, Rajiv. Organizacion Mundial de la Salud; Argentina Fil: Rao, Suman P.N.. Organizacion Mundial de la Salud; Argentina Fil: de Costa, Ayesha. Organizacion Mundial de la Salud; Argentina Fil: Gupta, Shuchita. Organizacion Mundial de la Salud; Argentina Fil: Shahidullah, Mohammod. No especifíca; Fil: Chowdhury, Saleha B.. No especifíca; Fil: Ara, Gulshan. No especifíca; Fil: Akter, Shaheen. No especifíca; Fil: Akhter, Nasreen. No especifíca; Fil: Dey, Probhat R.. No especifíca; Fil: Abdus Sabur, M.. No especifíca; Fil: Azad, Mohammad T.. No especifíca; Fil: Choudhury, Shahana F.. No especifíca; Fil: Matin, M.A.. No especifíca; Fil: Goudar, Shivaprasad S.. No especifíca; Fil: Dhaded, Sangappa M.. No especifíca; Fil: Metgud, Mrityunjay C.. No especifíca; Fil: Pujar, Yeshita V.. No especifíca; Fil: Somannavar, Manjunath S.. No especifíca; Fil: Vernekar, Sunil S.. No especifíca; Fil: Herekar, Veena R.. No especifíca; Fil: Bidri, Shailaja R.. No especifíca; Fil: Mathapati, Sangamesh S.. No especifíca; Fil: Patil, Preeti G.. No especifíca; Fil: Patil, Mallanagouda M.. No especifíca; Fil: Gudadinni, Muttappa R.. No especifíca; Fil: Bijapure, Hidaytullah R.. No especifíca; Fil: Mallapur, Ashalata A.. No especifíca; Fil: Katageri, Geetanjali M.. No especifíca; Fil: Chikkamath, Sumangala B.. No especifíca; Fil: Yelamali, Bhuvaneshwari C.. No especifíca; Fil: Pol, Ramesh R.. No especifíca; Fil: Misra, Sujata S.. No especifíca; Fil: Das, Leena. No especifíca

Background High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Findings Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81–1039·11; p

Background: There are numerous barriers leading to a high unmet need for family planning and contraceptives (FP/C). These include limited knowledge and information, poor access to quality services, structural inefficiencies in service provision and inadequately trained and supervised health professionals. Recently, social accountability programs have shown promising results in addressing barriers to accessing sexual and reproductive health services. As a highly complex participatory process with multiple and interrelated components, steps and actors, studying social accountability poses methodological challenges. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project study protocol was developed to measure the impact of a social accountability intervention on contraceptive uptake and use and to understand the mechanisms and contextual factors that influence and generate these effects (with emphasis on health services actors and community members). Methods: CaPSAI Project is implementing a social accountability intervention where service users and providers assess the quality of local FP/C services and jointly identify ways to improve the delivery and quality of such services. In the project, a quasi-experimental study utilizing an interrupted time series design with a control group is conducted in eight intervention and eight control facilities in each study country, which are Ghana and Tanzania. A cross-sectional survey of service users and health care providers is used to measure social accountability outcomes, and a cohort of women who are new users of FP/C is followed up after the completion of the intervention to measure contraceptive use and continuation. The process evaluation utilizes a range of methods and data sources to enable a fuller description of how the findings were produced. Conclusion: This complex study design could provide researchers and implementers with the means to better measure and understand the mechanisms and contextual factors that influence social accountability processes in reproductive health, adding important findings to the evidence base.

STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability questions were administered. MAIN RESULTS AND THE ROLE OF CHANCE There were 321 women included in the evaluable population (which includes all eligible women enrolled), with 141.9 woman-years (W-Y) of observation and with a rate (95% confidence interval [CI]) of 7.1 (3.8; 13.1) pregnancies per 100 W-Y of typical use (which reflects use of the study drug as main contraceptive method, but also includes possible use of other contraceptives from admission to end of study) and 7.5 (4.0; 13.9) pregnancies per 100 W-Y of sole use. In the primary evaluable population (which includes only eligible enrolled women

Background: Maternal mortality remains a daunting problem in Mozambique and many other low-resource countries. High quality antenatal care (ANC) services can improve maternal and newborn health outcomes and increase the likelihood that women will seek skilled delivery care. This study explores the factors influencing provider uptake of the recommended package of ANC interventions in Mozambique. Methods: This study used qualitative research methods including key informant interviews with stakeholders from the health sector and a total of five focus group discussions with women with experience with ANC or women from the community. Study participants were selected from three health centers located in Maputo city, Tete, and Cabo Delgado provinces in Mozambique. Staff responsible for the medicines/supply chain at national, provincial and district level were interviewed. A check list was implemented to confirm the availability of the supplies required for ANC. Deductive content analysis was conducted. Results: Three main groups of factors were identified that hinder the implementation of the ANC package in the study setting: a) system or organizational: include chronic supply chain deficiencies, failures in the continuing education system, lack of regular audits and supervision, absence of an efficient patient record system and poor environmental conditions at the health center; b) health care provider factors: such as limited awareness of current clinical guidelines and a resistant attitude to adopting new recommendations; and c) Users: challenges with accessing ANC, poor recognition amongst women about the purpose and importance of the specific interventions provided through ANC, and widespread perception of an unfriendly environment at the health center. Conclusions: The ANC package in Mozambique is not being fully implemented in the three study facilities, and a major barrier is poor functioning of the supply chain system. Recommendations for improving the implementation of antenatal interventions include ensuring clinical protocols based on the ANC model. Increasing the community understanding of the importance of ANC would improve demand for high quality ANC services. The supply chain functioning could be strengthened through the introduction of a kit system with all the necessary supplies for ANC and a simple monitoring system to track the stock levels is recommended. Fil: Biza, Adriano. No especifíca; Fil: Jille Traas, Ingeborg. No especifíca; Fil: Colomar, Mercedes. No especifíca; Fil: Belizan, Maria. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Requejo Harris, Jennifer. Johns Hopkins Bloomberg School of Public Health; Estados Unidos Fil: Crahay, Beatrice. No especifíca; Fil: Merialdi, Mario. No especifíca; Fil: Nguyen, My Huong. No especifíca; Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Alemán, Alicia. No especifíca; Fil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Carbonell, Alicia. No especifíca; Fil: Chavane, Leonardo. No especifíca; Fil: Delvaux, Therese. Institute of Tropical Medicine Antwerp; Bélgica Fil: Geelhoed, Diederike. No especifíca; Fil: Gülmezoglu, Metin. No especifíca; Fil: Malapende, Celsa Regina. No especifíca; Fil: Melo, Armando. No especifíca; Fil: Osman, Nafissa Bique. No especifíca; Fil: Widmer, Mariana. No especifíca; Fil: Temmerman, Marleen. No especifíca; Fil: Betrán, Ana Pilar. No especifíca

Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher. WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country’s health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘habits’ will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study. Pan African Clinical Trial Registry database. Identification number: PACTR201306000550192 .

BACKGROUND: To identify an effective misoprostol-only regimen for the termination of second trimester pregnancy, we compared sublingual and vaginal administration of multiple doses of misoprostol in a randomized, placebo-controlled equivalence trial. METHODS: Six hundred and eighty-one healthy pregnant women requesting medical abortion at 13-20 weeks' gestation were randomly assigned within 11 gynaecological centres in seven countries into two treatment groups: 400 microg of misoprostol administered either sublingually or vaginally every 3 h up to five doses, followed by sublingual administration of 400 microg misoprostol every 3 h up to five doses if abortion had not occurred at 24 h after the start of treatment. We chose 10% as the margin of equivalence. The primary end-point was the efficacy of the treatments to terminate pregnancy in 24 h. Successful abortion within 48 h was also considered as an outcome along with the induction-to-abortion-interval, side effects and women's perceptions on these treatments. RESULTS: At 24 h, the success (complete or incomplete abortion) rate was 85.9% in the vaginal administration group and 79.8% in the sublingual group (difference: 6.1%, 95% CI: 0.5 to 11.8). Thus, equivalence could not be concluded overall; the difference, however, was driven by the nulliparous women, among whom vaginal administration was clearly superior to sublingual administration (87.3% versus 68.5%), whereas no significant difference was observed between vaginal and sublingual treatments among parous women (84.7% versus 88.5%). The rates of side effects were similar in both groups except for fever, which was more common in the vaginal group. About 70% of women in both groups preferred sublingual administration. CONCLUSIONS: Equivalence between vaginal and sublingual administration could not be demonstrated overall. Vaginal administration showed a higher effectiveness than sublingual administration in terminating second trimester pregnancies, but this result was mainly driven by nulliparous women. Fever was more prevalent with vaginal administration. Registered with International Standard Randomized Controlled Trial number ISRCTN72965671.

Background Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. Methods/design This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate). Fil: Schvartzman, Javier A.. Centro de Educaciones Médicas e Investigación Clínica "Norberto Quirno"; Argentina Fil: Krupitzki, Hugo Bernardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina Fil: Betran, Ana Pilar. Department of Reproductive Health and Research. Ginebra; Suiza Fil: Requejo, Jennifer. Department of Reproductive Health and Research. Ginebra; Suiza Fil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina Fil: Gadow, Enrique Curt. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina Fil: Vizcaino, Francisco M.. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina Fil: Von Petery, Felicitas. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Borruto, Franco. Centre Hospitalier Princesse Grace; Mónaco Fil: Boulvain, Michel. Hopitaux Universitaires de Ginebra. Ginebra; Suiza Fil: Di Renzo, Gian Carlo. Santa Maria Della Misericordia University Hospital; Italia Fil: Gülmezoglu , Metin. World Health Organization. Ginebra; Suiza Fil: Hofmeyr, Justus. University of the Witwatersrand; Sudáfrica Fil: Judge, Kevin. Becton Dr. Franklin Lakes. New York; Estados Unidos Fil: Leung, Tak Yeung. The Chinese University of Hong Kong; Hong Kong Fil: Nguyen, My Huong. Department of Reproductive Health and Research. Ginebra; Suiza Fil: Saugstad, Ola Didrik. University of Oslo; Noruega Fil: Temmerman, Marleen. Department of Reproductive Health and Research. Ginebra; Suiza Fil: Treisser, Alain. Centre Hospitalier Princesse Grace; Mónaco Fil: Vayena, Effy. Universitat Zurich; Suiza Fil: Merialdi, Mario. Department of Reproductive Health and Research. Ginebra; Suiza