a<p>Miscarriage: termination of pregnancy and expulsion of an embryo or of a foetus prior t... more a<p>Miscarriage: termination of pregnancy and expulsion of an embryo or of a foetus prior to 20 complete weeks of gestation (as estimated by measurement of fundal height) and/or a birth weight less than 500 g.</p>b<p>Stillbirth: foetal death that occurs after 20 complete weeks of gestation.</p>c<p>Prematurity: birth before the beginning of the 37th week (assessed by the Ballard score).</p>d<p>Excluding incomplete data on Ballard score.</p>e<p>Perinatal death: foetal death that occurs during late pregnancy (at ≥28 completed weeks of gestation), childbirth and neonatal deaths within the first seven days of life.</p><p>Adverse pregnancy outcomes and serious adverse events by study arm (safety cohort).</p
a<p>RR.</p>b<p>Mean difference.</p>c<p>Assessed by the Ballard scor... more a<p>RR.</p>b<p>Mean difference.</p>c<p>Assessed by the Ballard score (excluding incomplete data). ITT analysis adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4).</p><p>Malaria-related outcomes at delivery.</p
a<p>RR.</p>b<p>Proportional difference. <i>p</i>-Value from censore... more a<p>RR.</p>b<p>Proportional difference. <i>p</i>-Value from censored regression (Tobit) using Wald test. Treatment comparison adjusted by country. Viral loads lower than 400 are considered as censored in the regression analysis. ITT analysis adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4).</p><p>HIV-related outcomes at delivery.</p
<p>Newborn weights not captured at birth but within the first week of life were estimated u... more <p>Newborn weights not captured at birth but within the first week of life were estimated using a linear regression model.</p
<p>ITT analysis adjusted by country. Interaction country×treatment: χ<sup>2</sup&g... more <p>ITT analysis adjusted by country. Interaction country×treatment: χ<sup>2</sup>: 1.22 with 3 degrees of freedom <i>p</i> = 0.766.</p><p>ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]). Interaction country×treatment: χ<sup>2</sup>: 0.31 with 3 degrees of freedom <i>p</i> = 0.959.</p><p>Low birth weight (<2,500 g at birth) rates by treatment group and country.</p
a<p>Episodes per person/year. ITT analysis adjusted by country. ATP analysis adjusted by ba... more a<p>Episodes per person/year. ITT analysis adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4).</p><p>PYAR, person/year.</p><p>Incidence of clinical malaria, outpatient visits, and hospital admissions.</p
<p>N, number of participants with at least one event.</p><p>Adverse events by s... more <p>N, number of participants with at least one event.</p><p>Adverse events by system organ class and treatment group.</p
a<p>OR of being in a given category or superior. ITT adjusted by country. ATP analysis adju... more a<p>OR of being in a given category or superior. ITT adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4). Interaction MQ×country, <i>p</i>-value = 0.842 for ITT, <i>p</i>-value = 0.771 for ATP cohort.</p><p>Adherence to cotrimoxazole categorized in tertiles.</p
Fostering international cooperation of research infrastructures (RIs) promotes the efficiency and... more Fostering international cooperation of research infrastructures (RIs) promotes the efficiency and quality of research worldwide and is key to tackling global challenges in a concerted manner. To this end, RI-VIS aims to provide tools and strategies to support the initiation and sustainability of international collaboration between research infrastructures. This deliverable presents three White Papers with region-specific recommendations on how to increase collaboration between European RIs and RIs from Africa, Latin America and Australia, respectively. The papers are targeted at funders, policy makers and research infrastructure managers and collate the insights of experts from RIs and policymakers from the respective regions into sections that cover examples of successful collaboration, lessons learned, and possible bottlenecks.
Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine ... more Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women.
Clara Menéndez and colleagues conducted a randomized controlled trial among HIV-positive pregnant... more Clara Menéndez and colleagues conducted a randomized controlled trial among HIV-positive pregnant women in Kenya, Mozambique, and Tanzania to investigate the safety and efficacy of mefloquine as intermittent preventative therapy for malaria in women receiving cotrimoxazole prophylaxis and long-lasting insecticide treated nets. Please see later in the article for the Editors' Summary
a<p>Miscarriage: termination of pregnancy and expulsion of an embryo or of a foetus prior t... more a<p>Miscarriage: termination of pregnancy and expulsion of an embryo or of a foetus prior to 20 complete weeks of gestation (as estimated by measurement of fundal height) and/or a birth weight less than 500 g.</p>b<p>Stillbirth: foetal death that occurs after 20 complete weeks of gestation.</p>c<p>Prematurity: birth before the beginning of the 37th week (assessed by the Ballard score).</p>d<p>Excluding incomplete data on Ballard score.</p>e<p>Perinatal death: foetal death that occurs during late pregnancy (at ≥28 completed weeks of gestation), childbirth and neonatal deaths within the first seven days of life.</p><p>Adverse pregnancy outcomes and serious adverse events by study arm (safety cohort).</p
a<p>RR.</p>b<p>Mean difference.</p>c<p>Assessed by the Ballard scor... more a<p>RR.</p>b<p>Mean difference.</p>c<p>Assessed by the Ballard score (excluding incomplete data). ITT analysis adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4).</p><p>Malaria-related outcomes at delivery.</p
a<p>RR.</p>b<p>Proportional difference. <i>p</i>-Value from censore... more a<p>RR.</p>b<p>Proportional difference. <i>p</i>-Value from censored regression (Tobit) using Wald test. Treatment comparison adjusted by country. Viral loads lower than 400 are considered as censored in the regression analysis. ITT analysis adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4).</p><p>HIV-related outcomes at delivery.</p
<p>Newborn weights not captured at birth but within the first week of life were estimated u... more <p>Newborn weights not captured at birth but within the first week of life were estimated using a linear regression model.</p
<p>ITT analysis adjusted by country. Interaction country×treatment: χ<sup>2</sup&g... more <p>ITT analysis adjusted by country. Interaction country×treatment: χ<sup>2</sup>: 1.22 with 3 degrees of freedom <i>p</i> = 0.766.</p><p>ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]). Interaction country×treatment: χ<sup>2</sup>: 0.31 with 3 degrees of freedom <i>p</i> = 0.959.</p><p>Low birth weight (<2,500 g at birth) rates by treatment group and country.</p
a<p>Episodes per person/year. ITT analysis adjusted by country. ATP analysis adjusted by ba... more a<p>Episodes per person/year. ITT analysis adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4).</p><p>PYAR, person/year.</p><p>Incidence of clinical malaria, outpatient visits, and hospital admissions.</p
<p>N, number of participants with at least one event.</p><p>Adverse events by s... more <p>N, number of participants with at least one event.</p><p>Adverse events by system organ class and treatment group.</p
a<p>OR of being in a given category or superior. ITT adjusted by country. ATP analysis adju... more a<p>OR of being in a given category or superior. ITT adjusted by country. ATP analysis adjusted by baseline variables (country, literacy, gestational age, gravidity, anemia, middle upper arm circumference, and CD4). Interaction MQ×country, <i>p</i>-value = 0.842 for ITT, <i>p</i>-value = 0.771 for ATP cohort.</p><p>Adherence to cotrimoxazole categorized in tertiles.</p
Fostering international cooperation of research infrastructures (RIs) promotes the efficiency and... more Fostering international cooperation of research infrastructures (RIs) promotes the efficiency and quality of research worldwide and is key to tackling global challenges in a concerted manner. To this end, RI-VIS aims to provide tools and strategies to support the initiation and sustainability of international collaboration between research infrastructures. This deliverable presents three White Papers with region-specific recommendations on how to increase collaboration between European RIs and RIs from Africa, Latin America and Australia, respectively. The papers are targeted at funders, policy makers and research infrastructure managers and collate the insights of experts from RIs and policymakers from the respective regions into sections that cover examples of successful collaboration, lessons learned, and possible bottlenecks.
Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine ... more Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women.
Clara Menéndez and colleagues conducted a randomized controlled trial among HIV-positive pregnant... more Clara Menéndez and colleagues conducted a randomized controlled trial among HIV-positive pregnant women in Kenya, Mozambique, and Tanzania to investigate the safety and efficacy of mefloquine as intermittent preventative therapy for malaria in women receiving cotrimoxazole prophylaxis and long-lasting insecticide treated nets. Please see later in the article for the Editors' Summary
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